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Alexza Pharmaceuticals Drops on Rejection of Schizophrenia Drug


Alexza says the FDA won't approve the drug Adasuve after citing manufacturing problems at a company plant. In premarket trading Friday, the stock fell 38%

Alexza Pharmaceuticals' (ALXA) shares are dropping after the company's experimental inhaled drug for schizophrenia was rejected by the Food and Drug Administration. Alexza says the FDA won't approve the drug after citing manufacturing problems at a company plant in Mountain View, California. The drug is designed to treat agitation in adults with schizophrenia or bipolar disorder. In premarket trading Friday, the stock fell 38% to $0.38 per share.

The drug, Adasuve, was rejected in 2010 on concerns about respiratory side effects. On the company's next attempt for approval, a panel of FDA expert advisers voted 9-8 in December to clear the drug for sale on the condition that the company develop a plan to mitigate risks with taking the drug. There's a concern about respiratory side effects going undetected in psychiatric patients. Alexza says it will talk to the FDA about both the manufacturing problems and what's known as a risk evaluation and mitigation strategy for the drug.

(See Pfizer, Gilead Sciences, Arena Pharmaceuticals Face Big Dates in May [UPDATE].)

Twitter: @brettchase

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