FDA advisory panel backs Alexza antipsychotic drug

The US Food and Drug Administration’s Psychopharmacologic Drugs Advisory Committee (PDAC) has voted narrowly (nine to eight, with one abstention) to recommend that USA-based Alexza Pharmaceuticals’ (Nasdaq: ALXA) Adasuve (Staccato loxapine) be approved for use as a single dose in 24 hours when used with the FDA recommended Risk Evaluation and Mitigation Strategy (REMS), for the treatment for agitation in patients with schizophrenia or bipolar mania. The news saw Alexza’s shares leap 25% to $0.78 by close of trading yesterday.

"We view the recommendations by the PDAC today as another step forward in the development of Adasuve,” stated Thomas King, president and chief executive of Alexza, adding: "We appreciate the Advisory Committee's recognition of agitation as a serious and underappreciated symptom of schizophrenia and bipolar disorder. If approved, we believe Adasuve represents a valuable treatment option for patients and physicians alike. We look forward to continuing to work toward our goal of bringing Adasuve to market in 2012."

As previously announced, the Adasuve NDA Prescription Drug User Fee Act (PDUFA) goal date is February 4, 2012. In Europe, a Marketing Authorization Application for Adasuve is currently under review by the European Medicines Agency and the application will follow the Centralized Procedure.