Novartis Pharmaceuticals Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved Enablex® (darifenacin) extended-release tablets (7.5mg and 15mg) for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and frequency. Enablex, a once-daily medication, is expected to launch in the U.S. in early 2005.
Enablex works by blocking the M3 receptor, which is primarily responsible for bladder muscle contraction. It is a potent muscarinic receptor antagonist that helps reduce incontinence episodes, increases the amount of urine the bladder can hold, reduces the frequency of urination episodes, and decreases the pressure or urgency associated with the urge to urinate.
"The M3 profile of Enablex is unique among all overactive bladder medications," said David Chaikin, MD, clinical assistant professor of urology at New York Hospital/Cornell Medical Center. "By combining sustained efficacy with a low incidence of central nervous system and cardiovascular side effects, Enablex will be especially useful as a new treatment option for overactive bladder."
The FDA approval of Enablex was based on efficacy data from four pivotal studies and safety data from studies in which more than 7,000 patients with a mean age of 58 years were treated with varying doses of Enablex. In these studies, patients taking Enablex experienced decreased frequency of incontinence and urination episodes, increased bladder capacity, and decreased feelings of urgency. Enablex was shown to reduce weekly incontinence episodes by up to 83 percent and results were seen within two weeks of beginning treatment. Efficacy was sustained throughout the 12-week treatment period, and long-term safety was studied for up to one year.
"Many patients with overactive bladder do not seek treatment for this condition and many of those who do remain unsatisfied. As we make Enablex available in the United States, we have the potential to bring unique benefits to these patients whose needs are not currently met," stated Paulo Costa, president and CEO, Novartis Pharmaceuticals Corporation.