The FDA has accepted Alexza Pharmaceuticals’ ADASUVE New Drug Application (NDA) as a complete, class II response to the FDA's action letter, with an indicated Prescription Drug User Fee Act (PDUFA) goal date of February 4, 2012. Alexza resubmitted the ADASUVE NDA, which seeks marketing approval for the rapid treatment of agitation in adults with schizophrenia or bipolar disorder.
Alexza's NDA is based on a comprehensive clinical development program including two positive phase III clinical trials. In addition to the data from the original NDA and supplemental analyses of some of these data, 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.
"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,” stated Thomas B. King, president and chief executive officer of Alexza.