FDA advisory committee recommends approval for schizophrenia, bipolar disorder drug
MOUNTAIN VIEW, Calif. — A Food and Drug Administration panel has voted to recommend approval for a psychiatric drug made by Alexza Pharmaceuticals.
Alexza said the FDA's Pychopharmalogic Drugs Advisory Committee voted 9-8 with one abstention to recommend approval of Adasuve (loxapine) for treating agitation in patients with schizophrenia and bipolar mania. The drug is administeredusing Alexza's proprietary Staccato inhaler technology. The FDA plans to decide whether or not to approve the drug in February. While the agency takes advisory committee recommendations into account when deciding whether to approve a drug, it is not bound by them but will usually follow them nonetheless.
"We view the recommendations by the PDAC today as another step forward in the development of Adasuve," Alexza president and CEO Thomas King said. "We appreciate the advisory committee's recognition of agitation as a serious and underappreciated symptom of schizophrenia and bipolar disorder."
More than 90% of patients with the disorders experience agitation, which starts with patients feeling uncomfortable, tense and reckless and can escalate into potentially violent behavior.