Alexza Shares Sink as the FDA Denies Its Antipsychotic Drug
Alexza'sStaccato system uses a hand-held inhaler to deliver the antipsychotic drug loxapine. When inhaled, the drug is quickly absorbed through the lungs into the bloodstream, says Alexa, providing comparable therapeutic speed to intravenous administration.
The FDA said it was primarily concerned about safety data from the three early-stage pulmonary studies with AZ-004, specifically, about lung function in healthy subjects and in subjects with chronic obstructive pulmonary disease (COPD) and asthma. Howver, some patients receiving placebo also exhibited the same decreased lung function.
The Mountain View, Calif., company adds that it found no serious or severe respiratory adverse events in these trials or in the two late-stage clinical trials of AZ-004.
"We appreciate the FDA's review of the first NDA [new drug application] for our novel Staccato technology, and we expect to work closely with FDA to resolve the issues raised in the Complete Response Letter," said Alexa President and CEO Thomas King. "Alexza continues to believe in the safety and efficacy of AZ-004 based on the comprehensive clinical development program we have conducted."
Valeant Pharmaceuticals (VRX) signed a deal with Alexza in February to develop and commercialize the AZ-004 in the U.S. and Canada.