Alexza To Meet With FDA To Address Concerns On Bipolar Drug Alexza (NASDAQ:ALXA) Intraday Stock Chart
Today : Monday 11 October 2010 Click Here for more Alexza Charts.
Alexza Pharmaceuticals Inc. (ALXA) said the Food and Drug Administration has decided a schizophrenic and bipolar disorder treatment isn't ready for approval, citing safety concerns.
Valeant Pharmaceuticals International Inc. (VRX) has agreed to commercialize the treatment, Alexza's lead candidate, in the U.S. and Canada. The drug is well-known and has been used for years, but combined with Alexza's inhaler delivery system it is proposed to provide rapid action and simple administration.
The FDA had safety concerns--decreases in forced expiratory volume and a measure of lung function that were observed early-stage testing, Alexza said. Suitability and stability worries also arose from the agency's pre-approval manufacturing inspection.
Officials from the company and the FDA will meet to discuss the next course.
Alexza shares closed Friday at $3.03 while Valeant finished at $26.84. Neither was active premarket.
-By Matt Jarzemsky, Dow Jones Newswires; 212-416-2240; matthew.jarzemsky@dowjones.com
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