Pfizer Inc said that the US Food and Drug Administration (FDA) approved Toviaz (fesoterodine fumarate) extended release tablets for the treatment of overactive bladder (OAB) symptoms. New once-daily Toviaz can significantly reduce the number of urge urinary incontinence episodes and the frequency of urination over 24 hours, symptoms of OAB that can significantly impact patients' lives. Overactive bladder is a bothersome medical condition that affects an estimated one in six Americans, yet still remains highly under treated. Toviaz is currently available in Europe.
Structurally related to the most prescribed OAB medication, Pfizer's Detrol LA (tolterodine tartrate extended release capsules), Toviaz can help regulate the involuntary contractions of the bladder associated with OAB. These contractions cause frequent, sudden urges to urinate. The two efficacious and well-tolerated doses of Toviaz, 4 mg and 8 mg, allow dosing flexibility to optimize treatment based on the individual patient response and tolerability.
"The emotional and social implications for people who suffer from OAB are challenging, yet the condition remains under-diagnosed and highly under treated," said Nancy Muller, executive director, National Association For Continence. "We need to encourage people with OAB symptoms to stop simply coping and start talking to their doctors about finding treatment approaches that work for them. New treatments, like Toviaz, offer healthcare professionals another option to help their patients."
Symptoms of OAB can have a profound effect on workplace productivity, social and sexual activity and sleep. Overactive bladder may also lead to other health problems, such as falls and fractures, urinary tract infections and skin disorders, sleep problems and depression. Despite the impact of OAB on patients' lives, research, including a March 2008 National Institutes of Health (NIH) report, concludes that the embarrassment and stigma associated with incontinence can cause sufferers to try to hide the condition from families, friends and even their doctors. As a result, many with incontinence conditions suffer without seeking help.
"Pfizer is proud to offer Toviaz, a new treatment for OAB symptoms that builds on our strong heritage in urology," said Jim Maffezzoli, senior director, group leader, Pfizer. "We will continue to partner with physicians and patients to provide extensive support and education to help enhance treatment success."
Dr Victor Nitti, professor and vice chairman of urology at the New York University Langone Medical Center and a principal investigator for Toviaz, added, "The FDA approval of Toviaz is good news for patients and treating physicians. Clinical trials with Toviaz showed strong efficacy and favourable tolerability, and the ability to titrate the dose of Toviaz allows physicians flexibility in treating each patient based on individual history and need."