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FDA Refuses To Approve Alexza's Adasuve On Manufacturing Issues, Shares Plunge

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5/4/2012 12:49 AM ET

Alexza Pharmaceuticals, Inc. (ALXA: Quote) Thursday said it has received a Complete Response Letter or CRL from the U.S. Food and Drug Administration regarding its New Drug Application for Adasuve (loxapine) inhalation powder, 5 mg and 10 mg, citing manufacturing deficiencies at its Mountain View, California facility. The stock fell about 37 percent in the extended trade.

Adasuve is being developed for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. The letter indicated that the NDA review cycle was complete and the application was not ready for approval in its present form.

The FDA said in the letter, "During a recent inspection of the Mountain View, CA manufacturing facility for this application, our field investigator conveyed deficiencies to the representative of the facility. Satisfactory resolution of these deficiencies is required before this application may be approved."

The company had received a CRL from the FDA previously in October 2010, citing breathing-related concerns associated with Adasuve.

Alexza said Thursday that it believes the deficiencies in the latest CRL concern medical devices and can be addressed readily. The company said there were no new clinical or safety issues identified and there were no other deficiencies outlined in the CRL issued by FDA's Center for Drug Evaluation and Research.

Regarding the Adasuve Risk Evaluation and Mitigation Strategy or REMS, the CRL said discussions could continue on the proposed REMS after submitting the response to the action letter.

The CRL also contained comments on Alexza's draft product labeling. The company believes that it has substantial agreement with the FDA on the REMS and product labeling.

Alexza plans to meet with the FDA as soon as practical to gain a better understanding of the specific deficiencies.

The firm said it looks forward to working to resolve the remaining issues in a timely manner.

ALXA closed on Thursday at $0.61, down $0.08 or 11.59 percent from the previous close, on 11.54 million shares compared to the 3-month average volume of 1.48 million shares. The stock declined $0.32 or 36.9 percent in the extended trade.

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by RTT Staff Writer

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