Alexza Pharmaceuticals Inc.'s (ALXA: Quote) inhalation antipsychotic drug candidate Adasuve poses a significant risk of bronchospasm, particularly in patients with asthma and chronic obstructive pulmonary disease, according to FDA briefing documents posted online yesterday.
Adasuve is a drug-device combination which uses Alexza's proprietary Staccato system to deliver the antipsychotic Loxapine into the patient's lungs. Alexza is seeking approval for Adasuve for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder. This is Adasuve's second go-around with the FDA.
The safety and efficacy issues of Adasuve are set to be reviewed by Psychopharmacologic Drugs Advisory Committee on December 12, 2011 and the panel will make its recommendations.
One essential question, which the FDA panel will be asked to vote on is whether Adasuve been shown to be sufficiently effective as a treatment for agitation in patients with schizophrenia or bipolar mania, given the pulmonary risks , and whether it been shown to be reasonably safe for use , when used in conjunction with the risk-mitigation strategy, or REMS, that has been proposed , to justify its approval.
There has not yet been a head-to-head comparison of Adasuve with other intramuscular forms of atypical antipsychotics that are already approved in the US., either alone, or in combination with benzodiazepines, as these products are often used in practice, according to the briefing documents.
The FDA is slated to give its final word on Adasuve on February 4, 2012. The FDA usually follows the recommendations of its advisory panels, but is not required to do so.
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by RTT Staff Writer
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