ALXA plunges 14.37% after FDA discussion over clinical safety of AZ-004 comes to an end

Alexza Pharmaceuticals, Inc (NASDAQ:ALXA) fell 14.37% after the Company announced that its End-of-Review meeting with the FDA that discussed the clinical safety of the Company’s AZ-004 New Drug Application (NDA).

Shares of the pharmaceutical company plunged by 24 cents and trade closed at $1.43 after trading in the range of $1.33-$1.47. Shares traded hands on high volume of 3.43 million shares as compared to the daily average trading volume of 1.04 million shares.

The Company’s market capitalization stands at $85.47 million on 59.77 million shares outstanding with the shares currently trading above its 50-Day Moving Average of $1.17 but below its 200-Day Moving Average of $2.07.

Alexza had received a Complete Response Letter (CRL) in October 2010 for its NDA AZ-004 indicating FDA’s decision that the product was not ready for approval in its present form. The End-of-Review meeting held in December 2010 with the FDA discussed clinical safety data from the three Phase 1 pulmonary safety studies with AZ-004.

The primary concern of FDA was the dose-related post-dose decreases in forced expiratory volume in one second, or FEV1 observed by the FDA based on the decrease in FEV1 recorded in the Company’s subjects who were administered with placebo versions of AZ-004.

The Company after presented evidence that the placebo device is safe by showing the changes seen was likely background events in the population studied and that the aerosol characterization does not indicate a basis for concern, was asked by the FDA to provide its arguments in the AZ-004 NDA resubmission.

Alexza will resubmit the AZ-004 NDA in July 2011 with a review period of 6 months which will include a REMS program proposal for the use of Staccato loxapine which will also include labeling, a medication guide, a communication plan, and post-approval studies to manage the potential risks.

The FDA is said to likely present the AZ-004 application to an Advisory Committee.

Alexza Pharmaceuticals, Inc. (Alexza) is a pharmaceutical company focused on the research, development, and commercialization of products for the acute treatment of central nervous system (CNS) conditions.