Toviaz drug meets endpoint in latest study


Pfizer Inc recently announced the results for the efficacy of the drug Toviaz that has been under study. The study (Study A0221048) was conducted to test the effectiveness in treating patients with overactive bladders and nocturnal urinary urgency.  
Primary endpoint was achieved, showing the drug was statistically significantly higher than results achieved by the placebo. The drug successfully reduced the amount of urinary episodes during hours of rest after 12 weeks.

Overactive bladder (a form of urinary incontinence) is a medical condition in which the victim of the condition experiences a sudden, forceful need to urinate due to bladder muscle spasms or contractions.
Overactive bladder is a highly bothersome condition, and it can lead to different medical problems including urinary tract infection, skin irritation, skin infection, and even bladder stones. Though the condition may not seem serious in terms of health risk, it can profoundly affect social and intimate situations. It is estimated that the condition affects 33 million people in America, but it is often left untreated, unrecognized, or undiagnosed.

Comparing efficacy and safety of the drug was governed by a double blind, randomized, double dummy, placebo controlled, panel group, multi-center trial to compare the drug and its varying doses with those of the effects of placebo. It involved 937 individuals at 108 different locations over the United States over a 12 week long period.

For the first two weeks, all of the patients were on a placebo. If a patient had less than or equal to a 35 percent reduction of urgent nocturnal episodes, they were sorted, randomly and blindly, into two groups. The first group received a fesoterodine 4 mg treatment and the second group remained on the placebo. Four weeks into the trial, investigators gradually increased the treatment to 8 mg per day, depending on patient self-reporting.

Dr.Steven J. Romano,  M.D., Senior Vice President, Head, Medicines Development Group, Global Primary Care Business Unit, Pfizer Inc. stated “Many patients with overactive bladder experience frequent interruptions during sleep hours from urinary urgency, which can be very disruptive and bothersome. In this study, Toviaz demonstrated efficacy in reducing the number of nocturnal urgency episodes”.

Though some common side effects during the treatment reported were dry mouth and constipation, there were not any significant safety concerns raised throughout the duration of the trial.