November 3, 2008
Pfizer Wins FDA Approval for Bladder Drug
Pfizer has announced that the FDA has approved Toviaz extended release tablets for the treatment of overactive bladder symptoms. Toviaz will be available in the US in the first half of 2009.
The approval of Toviaz is based on two large 12-week Phase III clinical studies of 1,964 overactive bladder (OAB) patients. In these studies, patients showed up to an 88% median reduction in urge urinary incontinence with Toviaz 8mg versus 50% with placebo.
According to the company, the 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.
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, 4mg and 8mg, allow dosing flexibility to optimize treatment based on the individual patient response and tolerability, the company said.
Jim Maffezzoli, senior director and group leader of Pfizer, said: "Pfizer is proud to offer Toviaz, a new treatment for OAB symptoms that builds on our strong heritage in urology. We will continue to partner with physicians and patients to provide extensive support and education to help enhance treatment success."