Allergan Inc. (AGN) filed applications with U.S. and European regulators for approval to sell Botox as a treatment for overactive bladder as two Phase III clinical trials showed the injectible neurotoxin significantly reduced urinary incontinence when compared with a placebo.
Botox is approved for both cosmetic use, such as fighting wrinkles, and for various medical issues, including urinary incontinence in patients with neurologic conditions such as spinal-cord injury and multiple sclerosis.
Allergan on Wednesday said Botox met the primary endpoints of significantly reducing urinary incontinence, or bladder leakage, episodes in patients who have an inadequate response to or are intolerant of an anticholinergic medication.
Based on the results, Allergan has submitted a supplemental biologics license application with the U.S. Food and Drug Administration and an application with European Regulatory authorities to approve the use of Botox by adult patients not managed by an anticholinergic treatment.
The drug maker has been expanding its pipeline of late, such as buying Vicept Therapeutics Inc., the developer of a cream to treat rosacea, and striking a deal with Map Pharmaceuticals Inc. (MAPP) to jointly promote Map's experimental migraine treatment Levadex.
Allergan reported last month its fourth-quarter earnings rose 6.3% as higher specialty pharmaceuticals sales contributed to a 7.1% revenue jump.
-By Melodie Warner, Dow Jones Newswires; 212-416-2283; [email protected]