Alexza Pharmaceuticals announced that the FDA has accepted its New Drug Application (NDA) for Adasuve (Staccato loxapine) for the rapid treatment of agitation in adults with schizophrenia. This submission was based on a comprehensive clinical development program including two Phase 3 trials. In a previous Phase 3 study, 344 patients with schizophrenia experiencing agitation received one, two, or three doses of loxapine (previously AZ-004) 5mg or 10mg or placebo. The primary efficacy endpoint was change from baseline in PANSS (Positive and Negative Syndrome Scale) Excited Component score (PEC), measured at two hours after the first dose of study medication. Results showed statistically significant reduction in agitation compared to placebo as assessed by this primary endpoint along with additional secondary endpoints.

In addition to the data from the original NDA, the resubmission contains new data from successfully completed human factors study, stability data, updated manufacturing and controls sections findings from the Company’s Pre-Approval Inspection, and updated draft labeling and comprehensive Risk Evaluation and Mitigation Strategy (REMS) proposal. The NDA was resubmitted on August 4, 2011 and was accepted 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. 

Adasuve is an anti-agitation product that combines loxapine, an antipsychotic with Alexza’s Staccato system that vaporizes the drug into small particle aerosol for inhalation which allows for rapid onset of action.

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