An FDA panel of experts recommended approval for Alexza Pharmaceuticals' ($ALXA) inhaled, fast-acting antipsychotic drug Adasuve, as long as the company limits the dose to once a day and follows regulators' risk-mitigation plan.
The Dec. 12 vote, however, landed barely in the favorable column--9 to 8 recommending approval, because of safety concerns over the treatment and its drug delivery system. Investors still liked the decision, driving the stock up 76% in early trading to $1.06, Bloomberg News reported. Alexza, based in Mountain View, CA, hopes to gain FDA approval and begin marketing the drug in 2012, CEO Thomas King said in a statement. Bloomberg noted in advance of the meeting that regulators have had genuine concerns about Adasuve, warning that it could harm some patients, making them vulnerable to respiratory problems or death.
The treatment, designed to address acute agitation related to schizophrenia or bipolar I disorder in adults, is a vaporized form of loxapine, a longtime antipsychotic. Alexza developed a proprietary hand-held inhalation device to deliver the vaporized drug directly to the lungs, so it can be absorbed more quickly through the bloodstream, a previous Bloomberg story explains.
Adasuve may be fast-acting--working within 10 minutes of inhalation, according to a company-funded study. But regulators in advance of the hearing said some patients will need respiratory care after an Adasuve dose, and others "will be at risk for respiratory failure and death," Bloomberg quoted the FDA as saying.
The FDA declined to approve the drug a little more than a year ago, according to the Bloomberg article, in part because of concerns over pulmonary toxicity. The company resubmitted its FDA approval application in August, with additional proposals to screen for respiratory problems and conduct patient monitoring.
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