Alexza Pharmaceuticals Announces PDUFA Goal Date

Alexza Pharmaceuticals, Inc. recently announced the US FDA has accepted the ADASUVE NDA as a complete, class 2 response to the FDA’s action letter, with an indicated Prescription Drug User Fee Act (PDUFA) goal date of February 4, 2012. On August 4, 2011, 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.

“If approved, ADASUVE would be the first drug marketed based on the novel Staccato technology platform,” stated Thomas B. King, President and CEO of Alexza. “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.”

Agitation can occur in many people suffering from major psychiatric disorders, including schizophrenia, which affects approximately 2.4 million adults in the US, and bipolar disorder, which affects approximately 5.7 million adults in the US. More than 90% of these people will experience agitation in their lifetime. Agitation generally escalates over a short period of time with patients initially feeling uncomfortable, tense, and restless. As the agitation intensifies, their behavior appears more noticeable to others as they become threatening and potentially violent, especially if the agitation is not treated. Agitation episodes are currently most often treated with antipsychotics and/or benzodiazepines in oral or intramuscular injection preparations. However, there are no non-invasive therapies that work within 30 minutes to help agitated patients in need of treatment.

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. In clinical studies, ADASUVE has shown an onset of effect in 10 minutes of dosing, which is the first time point measured in the Phase III clinical studies. The ADASUVE NDA contains efficacy and safety data from more than 1,600 patients and subjects who have been studied in 13 different clinical trials.