Alexza Pharmaceuticals Inc. ALXA -1.83% said the U.S. Food and Drug Administration needs an additional three months to complete its review of the company's new drug application for Adasuve, a schizophrenic and bipolar disorder treatment. The Prescription Drug User Fee Act date was extended to May 4 from Feb. 4. "We continue to believe that we are on a pathway to gain approval of Adasuve in the United States," said President and Chief Executive Thomas B. King. "We appreciate the efforts of the FDA to complete their review of our NDA and we will continue to support the continued review of the NDA." Alexza refiled its new drug application for the treatment in August, adding new data and sections that aimed to address safety concerns raised by the agency last year, and an FDA panel recommended Adasuve for approval last month. The drug has been used for years, but combined with Alexza's inhaler delivery system is proposed to provide rapid action and simple administration. Last month, the drug company said it hired an adviser to help it explore its strategic options and handed all of its employees 60-day layoff notices as it plans to significantly reduce its work force to conserve cash. Alexza reported in November its third-quarter loss widened sharply from a year earlier as it recorded higher research and development expenses and a loss on a contingent liability. Shares closed Friday at 80 cents and were inactive premarket. The stock has fallen 39% over the past three months. |
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