Pfizer received approval from the FDA for Toviaz extended release tablets for the treatment of overactive bladder (OAB) symptoms. The once-daily drug can help regulate the involuntary contractions of the bladder associated with OAB over a period of 24 hours. These contractions cause frequent, sudden urges to urinate. Overactive bladder affects an estimated one in six Americans but remains highly undertreated, according to the company. The two doses of Toviaz, 4 mg and 8 mg, allow dosing flexibility to optimize treatment based on the individual patient response and tolerability.

     The approval is based on two Phase III studies of 1,964 OAB patients. Patients showed an 88% median reduction in urge urinary incontinence with Toviaz 8 mg versus 50% with placebo. Treatment with 8 mg reduced the number of urinations per day by as much as 19% compared to an 11% reduction with placebo. Reductions in wetting accidents were seen as early as week two of treatment and maintained over 12 weeks.