According to Alexza Pharmaceuticals, the FDA has extended the Prescription Drug User Fee Act (PDUFA) date for the Adasuve Staccato loxapine NDA from February 4, 2012 to May 4, 2012. On January 10, 2012, Alexza submitted an updated proposed Risk Evaluation and Mitigation Strategy (REMS) program, which the FDA is considering a major amendment, allowing the agency to extend the PDUFA date by three months. Alexza submitted the revised REMS proposal in response to concerns expressed during a December 12 meeting of the Psychopharmacologic Drugs Advisory Committee.
At the December 12 meeting, the advisory committee recommended approval of Adasuve, an inhaled loxapine for the treatment of agitation in schizophrenics delivered by Alexza’s proprietary Staccato inhaler, if used with the FDA-recommended REMS. Alexza initially submitted the NDA in December 2009 and received a complete response letter in October 2010. The company resubmitted the NDA in August 2011.
In response to the PDUFA goal date extension, Alexza President and CEO Thomas B. King commented, “We continue to believe that we are on a pathway to gain approval of ADASUVE in the United States. We appreciate the efforts of the FDA to complete their review of our NDA and we will continue to support the continued review of the NDA.”
Read the Alexza press release.
