FDA extends review of Alexza product, shares fall

Alexza Pharmaceuticals Inc said U.S. health regulators extended the review date for its novel anti-psychotic treatment by three months after the company amended its approval application, sending its shares down as much as 19 percent.

The U.S. Food and Drug Administration notified Alexza that its updated risk evaluation and mitigation strategy program for the treatment, Adasuve, has been designated as a major amendment, and pushed the review date to May 4 from February 4.

Adasuve combines Alexza’s Staccato system—a hand-held, single-dose inhaler that delivers a medication comparable to intravenous administration—with loxapine, an anti-psychotic that is available as an oral drug for schizophrenia.

Three injectable drugs, Bristol-Myers Squibb’s Abilify, Eli Lilly’s Zyprexa and Pfizer’s Geodon, are already approved to calm down patients with schizophrenia or bipolar disorder, but Alexza’s product would be the first that is inhaled.

Alexza had submitted the amendment to its application earlier this month to address issues discussed during a regulatory advisory committee meeting on the Adasuve application in December.

The FDA had rejected Adasuve in October 2010 because of breathing-related side effects.

The company, which is currently exploring strategic options including a business combination, had cut all its jobs late last year to conserve cash.

Shares of the company were down 14 percent at 69 cents. They touched a low of 65 cents earlier in the session.

(Reporting by Esha Dey in Bangalore; Editing by Sreejiraj Eluvangal, Saumyadeb Chakrabarty)
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(Reuters)