Alexza Pharmaceuticals, Inc., a pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of CNS conditions, reported that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the US Food and Drug Administration (FDA) voted to recommend that 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 vote on this question was 9/8/1 (yes/no/abstain).
Adasuve is an anti-agitation product candidate that combines Alexza's proprietary Staccato system with loxapine, an antipsychotic currently available in the US as an oral formulation for the management of schizophrenia. The Staccato system is a hand-held, single-dose inhaler that delivers a medication comparable to intravenous administration, but with greater ease, patient comfort and convenience.
"We view the recommendations by the PDAC today as another step forward in the development of Adasuve," stated Thomas B. King, president and chief executive officer of Alexza Pharmaceuticals. "We appreciate the Advisory Committee's recognition of agitation as a serious and under appreciated 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 (MAA) for Adasuve is currently under review by the European Medicines Agency (EMA) and the application will follow the Centralized Procedure.
Agitation can occur in many people suffering from major psychiatric disorders, including schizophrenia, which affects approximately 2.4 million adults in the United States, and bipolar disorder, which affects approximately 5.7 million adults in the United States.