FDA approves Enablex for treatment of overactive bladder
New option offers unique M3 profile with proven efficacy, safety and tolerability
East Hanover, December 22, 2004 – 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.
OAB, a condition that affects an estimated 33 million Americans, is caused by the untimely contraction of the bladder muscle. At least 16 percent of the population over the age of 40 suffers from the chronic and troublesome symptoms of OAB. Although prevalence increases with age, the problem affects people of all ages. People with OAB often limit travel, social and even work activities to avoid potentially embarrassing episodes that can occur with this condition.
"Millions of patients and their families can be profoundly affected by overactive bladder. It is important that we continue to advance technology to bring new options to people with overactive bladder to help them manage this condition," said Nancy Muller, executive director, National Association for Continence.
In total, Enablex has been studied in 98 clinical trials involving more than 10,000 people. In clinical trials, the most frequently reported adverse events associated with Enablex were dry mouth and constipation, however patient discontinuation rates due to these events were low. The majority of adverse events in Enablex treated subjects were mild or moderate and mostly occurred during the first two weeks of treatment. As with other OAB medications, Enablex is contraindicated in patients with urinary retention, gastric retention or uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. Enablex is also contraindicated in patients with known hypersensitivity to the drug or its ingredients.
This release contains certain forward-looking statements relating to Novartis Pharmaceuticals Corporation's business, which can be identified by the use of forward-looking terminology, such as "is expected," "will be," and "have the potential to" or similar expressions, or by express or implied discussions regarding potential future sales of Enablex. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results with Enablex to be materially different from any future results, performance, or achievements expressed or implied by such statements. There can be no guarantee that Enablex will reach any particular level of sales. Any such results can be affected by, among other things, uncertainties relating to clinical trials, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection, competition in general, government, industry, and general public pricing pressures, as well as factors discussed in the Company's Form 20-F filed with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
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