FDA panel backs Alexza drug with limits

U.S. drug advisers recommended approving an experimental treatment from Alexza Pharmaceuticals for calming down patients with schizophrenia or bipolar disorder, but placed restrictions on how the drug should be used.

Advisers to the Food and Drug Administration on Monday voted 9 to 8 that Adasuve should be approved, but only if it is given in a single dose in 24 hours, and with the FDA’s safety strategy.

Adasuve caused some breathing problems for patients, especially for those who already had lung issues, and panelists were concerned such patients would not be properly screened in the real world with Alexza’s safety strategy.

The FDA usually follows the recommendation of its advisers, and will make the final decision on Adasuve in early 2012.

Shares of the Moutain View, California-based company were halted on Nasdaq pending the outcome of the meeting. (Editing by Bernard Orr)

(Reporting By Anna Yukhananov)

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reuters.com