BETHESDA, Md. (
(ALXA - Get Report)
is trying to convince an independent expert panel Monday that safety concerns focused on the risk of asthma-like side effects should not prevent the approval of its inhaled antipsychotic drug Adasuve.
Adasuve is a small, handheld device that delivers an inhaled dose of the antipsychotic drug loxapine into the lungs of patients. Adasuve is being developed for the rapid treatment of agitation in schizophrenia or bipolar disorder patients.
The U.S. Food and Drug Administration rejected Alexza's Adasuve application in October 2010 primarily due to concerns that inhaling the drug caused bronchospasms, or asthma-like constrictions of the lungs, in some patients.
Alexza resubmitted Adasuve to FDA, which asked an advisory panel of independent experts to review the drug/device Monday. The panel will be voting on whether or not to recommend Adasuve's approval.
In its morning presentation, Alexza argued that Adasuve is effective in treating acute episodes of agitation in schizophrenia patients. The company believes using an inhaled antipsychotic could be a meaningful benefit for agitated patients who typically must be physically restrained and treated with injections.
Alexza proposed a risk management plan that would screen out patients with lung problems and monitor patients treated with Adasuve to manage any bronchospasms, if they occur.
FDA used its presentation time at Monday's panel to raise questions about the way Alexza studies Adasuve in its clinical trials. The agency's reviewers said patients in the Adasuve studies were carefully screened which means they may have been better suited for Adasuve than "real world" schizophrenia patients. The FDA also presented data highlighting the lung safety concerns attributable to Adasuve.
The expert panel will spend the bulk of the afternoon debating the safety of Adasuve and will ultimately vote on whether to recommend approval or not.
Alexza shares were halted for trading Monday at 62 cents. The stock fell sharply last Thursday after FDA released its Adasuve review.
--Written by Adam Feuerstein in Boston.
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