After the FDA’s acceptance of Alexza Pharmaceuticals’s resubmitted NDA for Adasuve, the company has announced that the Prescription Drug User Fee Act (PDUFA) goal date will be February 4, 2012. Alexza had received a complete response letter for the Staccato inhaled loxapine product in October 2010 and resubmitted the application for approval of Adasuve as a treatment for agitation in adults with schizophrenia or bipolar disorder on August 4, 2011.
According to the company, “the Adasuve resubmission contains new data from a successfully completed human factors study, stability data from new production batches manufactured in late 2010, updated manufacturing and controls sections addressing findings from the Company’s Pre-Approval Inspection, and updated draft labeling and a comprehensive Risk Evaluation and Mitigation Strategy (REMS) proposal.”
Adasuve would be the first Staccato product on the market if approved. The Staccato inhaler creates an aerosol by heating a thin film of drug, which vaporizes and then condenses into particles in the 1-3 micron size range. Alexza is also developing Staccato products to deliver fentanyl, nicotine, alprazolam, and zaleplon.
“We believe Adasuve can offer physicians and patients a new therapeutic option, which combines rapid onset of action and reliability of medication delivery in a non-invasive formulation that is easy to administer. These are the key attributes outlined by the American Association for Emergency Psychiatry for the treatment of behavioral emergencies,” noted Thomas B. King, Alexza’s President and CEO.
Read the Alexza press release.
