FDA Approves Adasuve for Agitation with Schizophrenia, Bipolar I

Alexza Pharmaceuticals, Inc. announced today that the US Food and Drug Administration (FDA) approved Adasuve (loxapine) Inhalation Powder 10 mg for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

Adasuve combines Alexza's proprietary Staccato® delivery system with the antipsychotic drug, loxapine. The Staccato system is a handheld inhaler that delivers a drug aerosol to the deep lung that results in rapid systemic delivery and absorption of a drug. See below for Important Safety Information about Adasuve, including Boxed Warnings.

"The approval of Adasuve is an important event in the treatment of agitation. Adasuve is the first approved non-injectable therapy for the acute treatment of agitation in adults with schizophrenia and bipolar I disorder.

As noted in the consensus guidelines for Best Practices in the Evaluation and Treatment of Agitation, we believe that the ability to deliver medications rapidly and non-invasively will be important for patients and the professionals who care for them," said Thomas B. King, President and CEO of Alexza.

"This is a landmark day for Alexza and we are proud of our accomplishments in developing this unique product. We project that Adasuve will be available for commercial launch early in the third quarter of 2013."

"The data we have seen from the Adasuve Phase 3 clinical trials in patients with schizophrenia and bipolar I disorder are compelling," said Michael Lesem, MD, Executive Medical Director, Claghorn-Lesem Research Clinic, Houston, TX and a principal investigator in the Adasuve clinical trials.

"I believe that Adasuve represents an important new and much needed therapeutic option in treating agitation patients who will benefit from a non-coercive therapeutic intervention that works quickly to relieve their symptoms."

The FDA approval is based on a clinical data package involving more than 1,600 patients and subjects. In two Phase 3 trials, Adasuve was found to be effective in the acute treatment of agitation in adults with schizophrenia or bipolar I disorder.

In these two studies, Adasuve 10 mg met the primary efficacy endpoint, with statistically significant reductions in agitation as compared to placebo at the two-hour post-dose time point, as well as the principal secondary endpoint. Of note, Adasuve exhibited rapid effects in agitated patients, with statistically significant reductions in agitation apparent starting at 10 minutes following administration of a dose versus placebo.

As part of the Adasuve development program, Alexza identified a risk of bronchospasm in certain asthma and chronic obstructive pulmonary disease (COPD) patients following dosing with Adasuve.

It is important to note that Adasuve can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest. Adasuve will be available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Adasuve REMS.