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Gelnique® (oxybutynin chloride 10% gel) now available in Canada

Par WATSON PHARMA COMPANY on 12 septembre 2012

- First and Only Gel for Overactive Bladder

- Quick, convenient treatment option allows patients to treat OAB without having to take a pill

OAKVILLE, ON, Sept. 12, 2012 /CNW/ - Watson Canada today announced that Gelnique® (oxybutynin chloride gel), the first-ever topical gel for the treatment of overactive bladder (OAB), is now available in Canada. Gelnique provides patients with a novel alternative to current oral treatment options, with a very low incidence of side effects, such as dry mouth.

Gelnique is a quick-drying, clear, and fragrance-free gel that is applied once daily to the thigh, abdomen, upper arm or shoulder. A one-gram dose of Gelnique is rubbed into the skin like any skin cream, and delivers a constant dose of oxybutynin over a 24-hour period.

"Gelnique's novel gel formulation provides an important new option for patients with OAB," says Dr. Sender Herschorn, Professor and Chair University of Toronto Division of Urology. "Gelnique contains oxybutynin, the same ingredient as many available oral therapies, which has been well established as a safe and efficacious treatment for OAB. However, because Gelnique is absorbed through the skin and not taken by mouth, patients may experience limited anticholinergic side effects."

Current oral therapies for OAB are often associated with troubling side effects, such as severe dry mouth and constipation, often causing patients to discontinue use. Unlike oral treatments, Gelnique is delivered transdermally, and has been shown to cause few anticholinergic adverse effects. In clinical trials with Gelnique, no patients discontinued due to dry mouth.

MORE THAN AN INCONVENIENCE OR EMBARRASSMENT

Overactive bladder is a common, debilitating condition characterized by a sudden, uncomfortable need to urinate even when the bladder isn't full. It often results in an unexpected loss of urine, wetting accidents and the associated embarrassment.

In Canada, nearly one in five people over the age of 35 suffer from OAB. More than an inconvenience or embarrassment, OAB is associated with increased health risks and decreased quality of life. Patients with OAB can also have higher rates of hypertension, obesity, and even arthritis.

Although the prevalence of OAB is slightly higher in women, one in six men suffers from OAB (21.2 per cent vs. 14.8 per cent).

OAB IMPACTS RELATIONSHIPS & QUALITY OF LIFE

Both men and women with OAB are significantly more likely to report diminished sexual activity and enjoyment of sex because of urinary symptoms.

OAB has been shown to reduce sexual desire and the ability to achieve orgasm in women, and can be associated with increased prevalence of erectile dysfunction and reduced sexual enjoyment in men. Patients' partners report that OAB fosters significant emotions, including embarrassment, anxiety, anger, worry, frustration, and sympathy.

"Overactive bladder not only impacts overall health, but also sexual intimacy, romantic relationships, and self-confidence," says Maureen McGrath, Nurse Continence Advisor. "All patients should speak to their physician about sexual health when seeking a treatment for OAB as it can severely impact quality of life."

ABOUT GELNIQUE

Gelnique is indicated for the treatment of OAB with symptoms of urge urinary incontinence, urgency and frequency.

In a Phase 3, 12-week trial, one-gram, once-daily Gelnique was superior to placebo at relieving OAB symptoms, including a reduction in incontinence episodes and urinary frequency, and an increase in urine void volume. The treatment was well tolerated in the study with a low incidence of mostly mild side effects and no serious adverse events. The most frequently reported treatment-related adverse events (>2 per cent and greater than placebo) were dry mouth and application-site reactions (5.4 per cent).

Additional pharmacology studies showed that showering one hour or later, or applying oil-free sunscreen lotion 30 minutes before or after Gelnique application, did not significantly alter the absorption of the drug.

Gelnique significantly improved the quality of life domains of travel, physical activity, social relationships and emotional health.

For full prescribing information, please visit WatsonPharmaCompany.ca.

ABOUT WATSON PHARMA COMPANY

Watson Pharma Company is the newly-formed Canadian subsidiary of Watson Pharmaceuticals, Inc. Established in 2011 and headquartered in Oakville, Ontario, it is engaged in the marketing, sale and distribution of branded pharmaceutical products to the Canadian market. Watson is focused on delivering innovative products that address key therapeutic categories in Urology and Women's Health. As a subsidiary of Watson Pharmaceuticals, it is supported by Watson's sophisticated R&D and manufacturing capabilities, and one of the industry's leading global supply chains. For press release and other company information, visit Watson Pharma Company's website at www.WatsonPharmaCompany.ca

 

SOURCE: Watson Pharma Company

For further information:

Michelle MacLeod
Hill+Knowlton Strategies
416.413.4744 / Michelle.macleod@hkstrategies.ca

CNW

Overactive bladder linked to sleep apnea in women

Par Press Trust of India on 4 septembre 2012

Breathing difficulties in women while sleeping are linked to an overactive bladder, according to a new study.

Researchers from the Hospital del Mar in Barcelona, Spain, analysed 72 female patients referred to a sleep disorders clinic with suspected sleep apnea.

All patients completed a questionnaire asking them about four symptoms associated with their bladder control; urgency and frequency of urination, incontinence and nocturia. They were also asked to rate their discomfort with each of these symptoms.

Overactive bladder syndrome is characterised by an increased frequency to urinate along with incontinence and frequent awakening periods during night time to use the toilet (nocturia).

The need to urinate during the night is also a common symptom of sleep apnea, but little research has been carried out to investigate any links between the two conditions.

The new study analysed the questionnaires and 62 of the women were diagnosed with sleep apnea. The people within this group showed significantly higher scores for the prevalence of symptoms associated with bladder control and their discomfort with these symptoms.

Within the group diagnosed with sleep apnea, the symptoms were rated a median average score of 5, out of a possible total of 12, compared to a score of 3 in the group not diagnosed with the condition.

The median average score for discomfort with bladder control symptoms was 4 out of 12, compared with a score of 1 in the group of women who weren't diagnosed with sleep apnea.

"Overactive bladder has a prevalence of 16 per cent among people over 40 years in Europe and it is a difficult condition to live with, affecting a person's quality of life. The findings of this study provide evidence that bladder control could be linked to sleep apnea, although we do not know whether one of the conditions causes the other," lead author, Nuria Grau from the Hospital del Mar in Spain, said in a statement.

The research was presented at the European Respiratory Society's Annual Congress in Vienna.

Business Standard

Pfizer's phase 4 study of Toviaz in patients with overactive bladder meets primary endpoint

Par on 6 août 2012

Pfizer reported that the phase 4 study assessing the efficacy and safety of Toviaz (fesoterodine fumarate) in patients with overactive bladder (OAB) met its primary endpoint. Toviaz reduced urge urinary incontinence (UUI) in patients with OAB who had a suboptimal response (less than 50 per cent reduction in UUI) to Detrol LA (tolterodine tartrate extended release), a commonly-prescribed treatment for the condition. UUI is the involuntary leakage of any amount of urine, associated with or immediately preceded by a sense of urgency. The 14-week randomized, parallel group, placebo-controlled, double-blind multicentre study assessed Toviaz 8 mg in patients with OAB who had been taking Detrol LA 4 mg for two weeks and had less than 50 percent reduction in urge urinary incontinence episodes. After open-label treatment with Detrol LA 4 mg, treatment with Toviaz 4 mg was started for one week, followed by treatment with Toviaz 8 mg. The study demonstrated that Toviaz 4 mg for one week followed by Toviaz 8 mg statistically significantly reduced the average number of urge urinary incontinence episodes (-2.37 episodes from baseline) per 24 hours (p<0.0001) in OAB patients who had a suboptimal response to Detrol LA 4 mg. The safety and tolerability profiles of fesoterodine and tolterodine were consistent with previous studies. The most common treatment-emergent adverse events for both fesoterodine and tolterodine were dry mouth and constipation. Further analyses will be conducted and a publication of the comprehensive results is planned at a later date. “This study adds to the body of evidence supporting Toviaz as an effective treatment for patients with overactive bladder, including patients who may not have responded to Detrol LA,” said study principal investigator Dr. Steven A. Kaplan, professor of urology, Weill Cornell Medical College and director of the Iris Cantor Men’s Health Center at New York Presbyterian/Weill Cornell Medical Center in New York. “Health care professionals often question how to treat patients who have had a suboptimal response to Detrol LA, which is commonly used but does not have a dose higher than 4 mg, and these data may help to guide treatment decisions.” Overactive bladder is a treatable medical condition often caused by involuntary contractions or spasms of the bladder muscle. Overactive bladder symptoms of urgency, frequency or urge urinary incontinence can be bothersome and can have a significant impact on important aspects of people’s lives. Approximately 33 million American adults are estimated to suffer from OAB symptoms. Despite its prevalence, overactive bladder is often unrecognized and untreated. Toviaz (fesoterodine fumarate) treats the symptoms of overactive bladder (leaks, strong sudden urges to go, going too often). The recommended starting dose for Toviaz is 4 mg once daily. Based upon individual response and tolerability, the dose may be increased to 8 mg once daily. Toviaz should be swallowed whole; tablets should not be chewed, divided or crushed. DetrolLA (tolterodine tartrate extended release capsules) treats the symptoms of overactive bladder (leaks, strong sudden urges to go, going too often).

Pharmabiz.com

Quand on ne peut pas attendre

Par DIANE LAMARRE on 5 août 2012

Pendant les vacances, vous projetiez d’amener votre mère au chalet pour deux jours, mais voilà qu’elle se désiste sans que vous compreniez vraiment pourquoi. Même chose pour votre beau-père qui ne manquait jamais le tournoi de soccer de ses petits-enfants. Combien de fois, des patients sont venus me confier, à la pharmacie, leur déception de ne plus pouvoir participer à ces événements qui leur tenaient tant à cœur. À cette déception, s’ajoutent la gêne et parfois la honte. Ils souffrent d’une vessie trop active, une condition aussi appelée « hyperactivité vésicale » qui cause des envies soudaines et fréquentes d’uriner jusqu’à 8 ou 10 fois le jour et plus de 2 fois la nuit. Alors, pour éviter de déranger les autres, les personnes atteintes de ce problème, refusent ces petites sorties, tout en étant sensibles à la déception qu’elles causent à leurs proches. 10 % DE LA POPULATION On estime qu’environ 10 % de la population est atteinte d’une vessie hyperactive. Ce problème peut toucher des gens de tout âge, mais on estime que chez les gens de 60 ans et plus, une personne sur 5 en est incommodée. Il s’agit donc d’un problème fréquent et chronique caractérisé par une augmentation de la fréquence urinaire et par des urgences urinaires souvent responsables d’incontinences d’urgence chez le tiers des personnes. CONSÉQUENCES Des études ont permis de révéler que plusieurs individus, atteints d’hyperactivité de la vessie, prennent leur retraite prématurément parce qu’ils sont gênés de devoir, par exemple, s’absenter plusieurs fois pendant une même réunion pour des incontinences d’urgence. De plus, on a démontré que, dans leur empressement pour éviter une incontinence, des personnes âgées avec hyperactivité vésicale sont plus à risque de chutes et subissent en conséquence davantage de fractures. ON PEUT FAIRE QUELQUE CHOSE Des changements dans l’alimentation et les habitudes de vie, des exercices, certains médicaments, des produits contre l’incontinence et parfois une chirurgie peuvent faire une différence. MÉDICAMENTS On entreprend habituellement le traitement de cette condition avec un médicament appelé oxybutynine qui est efficace chez plusieurs personnes et disponible sous plusieurs formes (Ditropan XL,Uromax, Oxytrol – timbre, Gelnique-gel) . Il existe aussi d’autres options : ► Tolterodine (Detrol, Detrol LA) ► Darifénacine (Enablex) ► Fésotérodine (Toviaz) ► Solifénacine (Vésicare) ► Trospium (Trosec) Plusieurs patients ressentent toutefois certains effets indésirables en particulier, une sécheresse de la bouche et des yeux ainsi que de la constipation. Pour aider à obtenir un effet plus constant, on a commercialisé des formes à longue action qui agissent pendant 24 heures. Pour diminuer certains effets indésirables, on utilise aussi des médicaments sous forme de timbre ou de gel à appliquer sur la peau. Lorsqu’un de ces médicaments vous est prescrit une seule fois par jour, on recommande généralement de le prendre le soir ce qui diminue l’inconfort de certains effets secondaires. Ces médicaments peuvent habituellement diminuer 70 à 80 % des symptômes de l’hyperactivité de la vessie. PRODUITS D’INCONTINENCE Les protecteurs et les culottes contre l’incontinence peuvent apporter confort et sécurité et permettre de vaquer l’esprit tranquille à ses activités normales. Il faut bien noter que les serviettes hygiéniques contre les menstruations ne donnent pas du tout la même protection. Elles ne sont pas conçues pour absorber l’urine et donc leur pouvoir d’absorption est plus faible. Les produits contre l’incontinence sont conçus spécialement pour diminuer les fuites et contrôler les odeurs. Ils sont vraiment supérieurs quand il y a une incontinence. DES SOLUTIONS POSSIBLES Il existe donc plusieurs façons de diminuer les inconvénients causés par l’hyperactivité de la vessie. Ces différentes mesures peuvent permettre à nouveau de passer une nuit au chalet ou d’assister à un match de soccer en toute quiétude avec les enfants et les petits-enfants. L’important, lorsqu’on en est atteint, c’est d’en parler avec ses professionnels de la santé et ses proches. HABITUDES DE VIE QUI PEUVENT DIMINUER L’HYPERACTIVITÉ DE LA VESSIE ► Réduire la consommation de caféine en ne buvant pas plus de deux tasses de café, de cola ou de thé par jour. ► Ne pas forcer lorsque vous urinez et prendre le temps de vider complètement la vessie. ► Faire certains exercices des muscles du plancher pelvien comme les exercices de Kegel. ► Limiter la consommation d’alcool à 1 ou 2 consommations par jour. ► Avoir un poids santé, car il est démontré que la perte de poids chez une personne obèse diminue l’incontinence d’urgence. Contrôler certaines autres conditions peut aussi aider à diminuer les problèmes de vessie hyperactive, par exemple : ► Le diabète ► L’infection urinaire ► L’apnée du sommeil ► L’œdème périphérique (enflure des chevilles, par exemple)

Journaldemontreal.com

Overactive Bladder Risk Higher in Diabetics

Par Jody A. Charnow on 27 juillet 2012

Patients with type 2 diabetes are at significantly higher risk for overactive bladder (OAB) symptoms than nondiabetics, according to researchers. In addition, among type 2 diabetics, higher glycosylated hemoglobin (HbA1c) levels predict a significantly increased likelihood of OAB/urgency, urge incontinence, and nocturia. Hann-Chorng Kuo, MD, of Buddhist Tzu Chi General Hospital Hualien, Taiwan, and colleagues studied 279 type 2 diabetics and 578 age- and gender-matched controls without diabetes. OAB was present in 28% of the diabetics compared with only 16.3% of controls, which translated into a twofold increased risk of OAB in the diabetics, Dr. Kuo's team report online in the International Journal of Urology. Urgency also was present in 28% and 16.3% of diabetics and controls, respectively. Forty-eight percent of the diabetics had nocturia compared with 39.1% of controls, which translated into a 44% increased risk of nocturia among the diabetics. In addition, among diabetics, each one-point rise in HbA1c was associated with a significant 24%, 20%, and 17% increased risk of OAB/urgency, urge incontinence, and nocturia, respectively.

RenalandUrologynews.com

Merus Labs International Inc. Announces Acquisition of Emselex®/Enablex®

Par Merus Labs International Inc. on 11 juillet 2012

Merus Labs International Inc. ("Merus" or the "Company") (TSX:MSL)(NASDAQ:MSLI) is pleased to announce that it has acquired from Novartis Pharma AG ("Novartis") the Canadian and European rights (excluding France, Spain and Italy) to manufacture, market, and sell the branded prescription medicine product Emselex®/Enablex® (darifenacin) extended release tablets. Darifenacin is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. In calendar year 2011, the product had net sales of approximately US$23 million in the territories acquired. The Company funded the Emselex®/Enablex® acquisition with cash on hand and a debt facility provided to Merus by PDL BioPharma, Inc. ("PDL") (NASDAQ:PDLI), a company supporting the healthcare industry with creative financing solutions. Other financial terms of the acquisition were not disclosed. Pursuant to the acquisition, Merus acquired the Emselex®/Enablex® trademark and patent, certain related intellectual property, and other information and materials required to continue marketing the brand in the territories acquired. "We are pleased to have completed this product acquisition with Novartis, a top tier pharmaceutical company, which has built significant brand equity in the Emselex®/Enablex® product over the years. The addition of darifenacin will broaden the Company's existing product portfolio, expand our geographic focus, and bring scale to our business. We are also pleased to have entered into a strategic relationship with PDL, a sophisticated healthcare investor which we look forward to working with regarding financing solutions for future product acquisition opportunities," said Elie Farah, President and CEO-elect of Merus Labs International Inc. Byron Capital Markets Ltd. of Toronto, Canada acted as advisor to Merus in regard to the transaction. About Merus Labs International Inc. Merus is a specialty pharmaceutical company engaged in the acquisition and licensing of pharmaceutical products. The Company utilizes its expertise in pharmaceutical markets and its access to capital to acquire and license niche branded products. Merus further enhances the sale and distribution of these products by the introduction of a focused marketing and promotion plan. Cautionary Statement Certain statements contained in this press release may constitute "forward-looking statements" within the meaning of Section 21E (i) (1) of the United States Securities Exchange Act of 1934. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Merus' actual results to be materially different from any future results expressed or implied by these statements. Such factors include the following: general economic and business conditions, changes in demand for Merus' products, changes in competition, the ability of Merus to integrate acquisitions or complete future acquisitions, interest rate fluctuations, currency exchange rate fluctuations, dependence upon and availability of qualified personnel and changes in government regulation. In light of these and other uncertainties, the forward-looking statements included in this press release should not be regarded as a representation by Merus that Merus' plans and objectives will be achieved. These forward-looking statements speak only as of the date of this press release, and we undertake no obligation to update or revise the statements.

Marketwire.com

FDA approves Astellas drug for leaky bladder

Par Anna Yukhananov on 28 juin 2012

U.S. drug regulators approved Astellas Pharma Inc's pill for overactive bladder on Thursday, boosting the Japanese drugmaker's foothold in the market for the condition. The Food and Drug Administration approved the once-daily pill, to be sold as Myrbetriq, for adults who cannot control their bladder muscles, following a positive recommendation from FDA advisers. The FDA said about 33 million Americans have an overactive bladder, whose symptoms include frequent urination and urgency to urinate. The condition is especially common among those 75 years of age and older. Myrbetriq, the first drug in its class, works by activating a protein receptor in bladder muscles that relaxes them and helps the bladder fill and store urine. The pill is already approved in Japan. "Overactive bladder ... is uncomfortable, disrupting and potentially serious," said Dr. Victoria Kusiak, deputy director in an FDA office for drug evaluation. In April, a panel of outside advisers to the FDA voted 7-4 that the benefits of the pill, known chemically as mirabegron, outweighed its possible risks to the heart and liver. In clinical trials, a 50-milligram dose of the drug meant four fewer trips to the bathroom over seven days compared with placebo, and three fewer episodes of urine leakage, or incontinence. Some FDA advisers had said that may not greatly help people who often go to the bathroom at least eight times a day. However, the FDA had said clinical trials only had to prove the drug was better than a placebo, prompting a majority of panelists to vote in favor of the drug. Common side effects were elevated blood pressure, urinary tract infection, elevated heart rate and abdominal pain. The FDA said people with very high uncontrolled blood pressure or serious kidney or liver disease should not take the pill. Astellas, Japan's second-largest drugmaker, already makes the overactive bladder drug Vesicare. It is one of the company's biggest products, and had global sales of 86.7 billion yen ($1.1 billion) in 2010.

reuters.com

Pelvic Floor Disorders: Doctor designs Pfilates, exercises for pelvic floor muscles

Par Pelvic Floor Disorders: Doctor designs Pfilates, exercises for pelvic floor muscles on 20 juin 2012

Keira Wetherup Brown calls 2008 her “dark year.” That’s when her pelvic organs slipped out of place. She was diagnosed with a minor bladder prolapse after delivering her first child, but the bladder fell further and the rectum also dropped after her second child was born. “It was tediously uncomfortable,” says Brown, 41. “Inside I felt shredded.” Hoping to delay surgery as long as possible, she found a physiotherapist who helped her strengthen her pelvic muscles to keep the organs from falling further, and she discovered Pfilates, a pelvic floor exercise routine, that she does at home. Pfilates exercises But she regrets that she didn’t strengthen those muscles before pregnancy — and that no medical professionals encouraged it. “Maybe I could have staved off the prolapse,” she wonders. “We need to be proactive about the pelvic floor.” It’s not an area of the body that gets much attention — until a person leaks or organs painfully shift. “You should be working your pelvic floor muscles all your life, just like you work your biceps,” says Toronto physiotherapist Julia DiPaolo. Some doctors tell patients to do Kegel exercises, an up-and-in squeeze motion, but rarely offer instruction or follow-up. Patients tend to do them incorrectly —if at all, says DiPaolo, owner of Physio Excellence. The pelvic floor is a bowl-shaped area of muscles and connective tissues that keep the bladder, bowel, and uterus in place. Nearly 24 per cent of adult women struggle with at least one pelvic floor disorder — urinary incontinence, fecal leakage or organ prolapse — according to a national health survey in the U.S. The major risk factors are pregnancy, hysterectomy, obesity, genetics and age. Men can also develop pelvic floor disorders, such as incontinence after prostate surgery. Rather than admit to a problem, some men just use their wives’ liners and pads, says DiPaolo. “I’m blown away by what people live with,” says Trista Zinn, a personal trainer who works with pre- and postnatal women and adults over 60. “Mothers have told me they can’t laugh or run after their children without leaking.” Some women pee when they cough, or even stand up. “It’s absolutely not an inevitable consequence of childbirth and aging,” says urogynecologist Bruce Crawford, who designed the Pfilates exercise program. “That’s one of the major barriers to care — hopelessness.” Medication or surgery can help many cases. But after performing 2,500 surgical repairs for urinary incontinence, Crawford was frustrated. “Clearly the problem was the strength of the pelvic floor muscles,” says the Nevada surgeon. In 2008, he studied 120 moves from Pilates, yoga and personal trainers’ routines by hooking up volunteers to an electromyography machine. He identified 10 moves that best engaged the pelvic floor and the transverse abdominals, gluteals and thigh adductors which work with the floor muscles. Pfilates uses the 10 moves in a series of repetitions and progressive phases that can be part of a regular workout routine. Crawford, who was in Toronto recently to certify physiotherapists and fitness trainers in his program, also sells an at-home kit that includes an instructional DVD. (For more information, visit pfilates.com.) He’s currently working on a pelvic floor exercise program geared toward men that would use many of the same movements. Christina Daly, who took Crawford’s course last year, thinks Pfilates is a good alternative to the Kegel exercises. “You can feel yourself do a lunge, contract the glutes,” says Daly, a physiotherapist at Work-Fit Total Therapy at Oakville Trafalgar Hospital. “With more sensory feedback, you’re more likely to stay with it.” Personal trainer Zinn has seen results with Pfilates. “Clients tell me they’re not going to the washroom as much, that they can laugh or cough without leaking,” says Zinn, who works at Totum Performance. Dr. Susan Meikle, program director of the Pelvic Floor Disorders Network — clinical centres in the U.S. studying treatment and prevention — isn’t familiar with Pfilates, but says that studies show that exercises can help reduce the disorders. Most studies, however, have looked at one-on-one physical therapy exercise, not gym-based programs. Some common exercises, such as heavy weight lifting, could make a pelvic floor disorder worse, says Toronto trainer Zinn. “Some of us are trying to get gyms to include questions about pelvic floor dysfunction,” she says. “If there’s a red flag, the person would be sent for assessment before starting a program.” Of pelvic floor disorders, the most common is urinary incontinence, with 15.7 per cent of women reporting it, according to the U.S. national health survey. Nine per cent had fecal incontinence and 2.9 per cent experienced pelvic organ prolapse. Stunned by her prolapse diagnosis, Brown has become an advocate for women and started a website, livingwithprolapse.com. Her message: Strengthen those pelvic floor muscles. “Any women who are pregnant I start telling them about it,” she says.

Healthzone.ca

AUA Foundation Launches Campaign to Address Stigma of Overactive Bladder It's Time to Talk About OAB Aspires to Help Patients Discuss and Manage Treatable Condition

Par Wendy Waldsachs Isett and Taryn Berman on 19 juin 2012

On the heels of the fourth annual World Continence Week, the American Urological Association (AUA) Foundation has launched "It's Time to Talk About OAB," a nationwide education campaign designed to elevate awareness of Overactive Bladder (OAB), a common, yet often untreated condition, as a public health issue. As many as 30 percent of men and 40 percent of women in the United States have the condition. The campaign's goal is two-fold: help patients better understand OAB symptoms and de-stigmatize the condition so that patients feel comfortable initiating a conversation with their healthcare professional – ultimately leading to diagnosis and treatment. In tandem with the campaign launch, the AUA Foundation has also kicked-off its official call-for-entries for the Voices of OAB contest. As part of the contest, the AUA Foundation is seeking first-hand stories from patients living with OAB. To enter the Voices of OAB contest, patients should visit the dedicated Facebook page to share an audio testimonial about how OAB impacts their daily life. Official contest rules, resources and news of interest are all available on the page. The entry period will run through August 31, 2012 and official winners will be announced later this fall. Winners of the Voices of OAB contest will receive tablets loaded with applications and OAB management tools, such as the Bladder Pal, which helps patients track their bladder function. OAB is a group of urinary symptoms that include a strong, uncontrollable urge to urinate at unexpected times, which may result in urine leakage (incontinence) and/or frequent urination during the day and night. Not all patients with OAB suffer from incontinence. The symptoms of OAB can occur if the muscles in a patient's bladder contract involuntarily when it isn't yet filled with urine. Sometimes the nerve signals between the brain and bladder go awry, sending messages to empty the bladder at unexpected times. This creates a strong urge to urinate before the bladder is full. Though not life-threatening, OAB can cause a significant impact on a patient's quality of life. Because people may be too embarrassed to share their symptoms or seek treatment, there are likely many more that suffer unnecessarily from OAB. "We know all too well that people with OAB often keep quiet about their symptoms," said Kathleen Kobashi, MD, Head of the Section of Urology and Renal Transplantation at Virginia Mason Medical Center; Co-Director of the Pelvic Floor Center; Director of the clinical fellowship in Pelvic Floor Medicine; Associate Clinical Professor of Urology at the University of Washington in Seattle, WA and member of the AUA Foundation's OAB Expert Panel. "We want men and women to know that they have options; there is no need to endure the discomfort of OAB alone or in silence. The condition is manageable, but people need to take the first step and speak up about their OAB." Mike Sheppard, Executive Director of the AUA Foundation added: "We are extremely optimistic about the impact of this hallmark education initiative, which will offer patients the help they need to take control of their OAB symptoms. It is our hope that by fostering open dialogue, especially through our Voices of OAB contest and physician interaction tips, we will have a positive impact on the health of Americans living with OAB." In addition to the Voices of OAB contest and Facebook presence, "It's Time to Talk About OAB" is anchored by a dedicated website, www.ItsTimeToTalkAboutOAB.org, which features helpful disease information, a monthly expert blog and patient-focused education materials. The AUA Foundation has also set-up a private discussion forum on www.Inspire.com, a leading provider of health and wellness communities. For more information about "It's Time to Talk About OAB" or the Voices of OAB contest, visit www.ItsTimeToTalkAboutOAB.org. The campaign was developed by the AUA Foundation with support from Astellas Pharma US, Inc. About Overactive Bladder Overactive Bladder (OAB) is the name given to a group of urinary symptoms that include a strong, uncontrollable urge to urinate at unexpected times, which may result in urine leakage (incontinence), and frequent urination during the day and night. Both men and women are at risk for OAB, however, women who have experienced menopause and men who have had prostate problems are at greater risk for symptoms. Though not life-threatening, OAB can cause a significant impact on a patient's quality of life. Some patients suffering from the symptoms of OAB restrict their daily lives, limiting their social and occupational activities when bathroom access may be difficult. Some people may actually avoid leaving their homes – even to visit their physician. Others report negative impacts on their sexual function and marital satisfaction. There are a number of treatments available for OAB, which a healthcare professional may use alone or in combination. These options include lifestyle changes such as behavioral therapy, fluid management, bladder training or pelvic floor muscle exercises, though some patients may require medications, called anti-muscarinics, or other treatment options. The AUA Foundation has a panel of experts available for media interviews on OAB. To arrange an interview with an expert, please contact Taryn Berman (bermant@ruderfinn.com) or Wendy Isett (wisett@AUAnet.org). About the AUA Foundation The AUA Foundation is the world's leading nonprofit urological health foundation and the official foundation of the American Urological Association. We partner with physicians, researchers, healthcare professionals, patients, caregivers, families and the public to support and improve the prevention, detection and treatment of urological diseases through research and education. To learn more about the AUA Foundation and its campaigns visit: www.urologyhealth.org. About Astellas in Urology Astellas Pharma US, Inc., located in Northbrook, Illinois, is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The company is committed to becoming a global category leader in urology and providing solutions for physicians and patients through the discovery of new treatments for OAB and other urologic conditions, including benign prostatic hyperplasia, pelvic pain and urologic cancers. Astellas currently markets the number one branded OAB treatment in the U.S. For more information about Astellas Pharma US, Inc., please visit www.astellas.us.

PR Newswire

Pfizer Canada Introduces Toviaz(TM), A New Treatment for Canadians Suffering from Overactive Bladder

Par Pfizer Canada on 7 juin 2012

Fewer than 9 percent of OAB sufferers are diagnosed(1)

MONTREAL, QUEBEC, Jun 06, 2012 (MARKETWIRE via COMTEX) -- Pfizer Canada announced today that Toviaz(TM) (fesoterodine fumarate extended release tablets) is now available in Canada. Toviaz is a prescription medication indicated for the treatment of patients with overactive bladder (OAB) with symptoms of urinary frequency, urgency, or urge incontinence, or any combination of these symptoms.(2)

Overactive bladder is a condition that affects one in five Canadian women over the age of 35 and one in seven Canadian men over the age of 35(3), yet remains under-treated. It is estimated that fewer than 9 percent of sufferers have been diagnosed, although 24 percent of sufferers describe their condition as "a great concern" that impacts negatively on their quality of life.(4) People with OAB often delay seeking help and wait an average of 3 years before consulting a physician.(5)

Dr. Sender Herschorn, Professor and Chair, Division of Urology at the University of Toronto, says that research is demonstrating that OAB is much more common than physicians originally believed and impacts more negatively on people's sense of health and well-being than what was previously thought.(6) "One possible reason for this is that patients may be embarrassed to discuss their overactive bladder symptoms with a physician," said Dr. Herschorn. "They often develop coping strategies, such as planning "escape routes" to restrooms in public places, which allow them to delay seeking treatment. Many rely on adult pads and diapers, restrict their fluid intake, and restrict their activities and interactions to situations where they can be sure a washroom is always nearby."

Toviaz is the newest addition to Pfizer's OAB portfolio

"Given Pfizer Canada's long heritage in the overactive bladder market with Detrol and Detrol LA, we understand that experiences and challenges with overactive bladder differ from patient to patient," said Dr. Bernard Prigent, Vice-President and Medical Director, Pfizer Canada. "The approval of Toviaz gives Canadian physicians a new option to help address these challenges for patients."

Toviaz is available in two doses, 4 mg and 8 mg to be taken once daily, and is now available in Canadian pharmacies.(7)

The approval of Toviaz by Health Canada is based on two Phase 3 randomized, double-blind, placebo-controlled, 12-week studies. The trials randomized 1,135 and 836 patients respectively. The co-primary endpoints were the change from baseline to week 12 in the average number of micturitions per 24 hours and a change from baseline to week 12 in the average number of urge urinary incontinence episodes per 24 hours (US analysis) or treatment response derived from the Treatment Benefit Scale (European analysis). The safety of Toviaz was primarily evaluated in Phase 2 and 3 controlled trials in a total of 2859 patients with overactive bladder of which 2,288 were treated with fesoterodine.(8)

About Pfizer Canada

Pfizer Canada Inc. is the Canadian operation of Pfizer Inc, one of the world's leading biopharmaceutical companies. Pfizer Canada has nearly 3,000 employees working at six facilities across Canada and in many other communities in every province. They are the heart of Pfizer's ability to contribute significantly to Canadians' health and economic well-being through the company's provision of prescription and non-prescription medicines, vaccines, generic medicines, and animal health products, as well as its investments and job-creation in research and development and manufacturing.

Every day, Pfizer Canada employees work to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. We apply science and our global resources to improve the health and well-being of Canadians at every stage of life. Our commitment is reflected in everything we do, from our disease awareness initiatives to our community partnerships, to our belief that it takes more than medication to be truly healthy. To learn more about Pfizer's More Than Medication(TM) philosophy and programs, visit www.morethanmedication.ca . To learn more about Pfizer Canada, visit www.pfizer.ca .

(1) Nitti VW et al. Efficacy, safety and tolerability of fesoterodine for overactive bladder syndrome. J Urol 2007;178:2488-2494.

(2) Chapple C et al. Clinical efficacy, safety, and tolerability of once-daily fesoterodine in subjects with overactive bladder. Eur Urol 2007;52:1204-1212.

(3) Corcos, J; Schick, E; et al. Prevalence of Overactive Bladder and incontinence in Canada. The Canadian Journal of Urology. 2004; 11: 2281-84.

(4) Khullar V, Chapple C, Gabriel Z, et al. The effects of antimuscarinics on health-related quality of life in overactive bladder: a systematic review and meta-analysis. Urology 2006;68(2 Suppl):38-48.

(5) Milsom, I, et al. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001; 87: 760-766.

(6) Canadian Continence Association. Impacts of Incontinence in Canada. A briefing document for policy makers. May 2009

(7) Pfizer Canada Inc. TOVIAZ Product Monograph. February 2012

(8) Nitti VW et al. Efficacy, safety and tolerability of fesoterodine for overactive bladder syndrome. J Urol 2007;178:2488-2494

Contacts:         For more information or to coordinate an interview         with Dr. Herschorn, please contact:         Strategic Objectives         Catherine Heroux or Deb Quinn          1-866-366-7733          cheroux@strategicobjectives.com                  Pfizer Canada         Christina Antoniou          1-866-9Pfizer  (or  866-973-4937 )         christina.antoniou@pfizer.com   www.pfizer.ca

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