Alexza's AZ-004 (Staccato(R) Loxapine) Phase 3 Trial Meets Primary Endpoint of Treating Acute Agitation in Schizophreni...( Conference Call Scheduled for Today...),Health

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MOUNTAIN VIEW, Calif., Sept. 2 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today announced positive results from its first Phase 3 clinical trial of AZ-004 (Staccato(R) loxapine) in schizophrenic patients with acute agitation. Both the 5 mg and 10 mg doses of AZ-004 met the primary endpoint of the trial, which was a statistically significant reduction in agitation from baseline to the 2-hour post-dose time point, compared to placebo. AZ-004 is an inhalation product candidate being developed for the treatment of acute agitation in patients with schizophrenia or bipolar disorder. AZ-004 is being developed through Symphony Allegro, a product development partnership formed between Alexza and Symphony Capital, LLC.

"Alexza initiated the first Phase 3 clinical trial of our lead program in late February and completed enrollment in less than four months, and today we are reporting positive top-line results for the primary and secondary endpoints," said James V. Cassella, PhD, Alexza Senior Vice President, Research and Development. "We believe that the ability to provide loxapine via our Staccato technology, thus combining a drug with a well-established mechanism of action with rapid absorption and patient self-administration, makes AZ-004 a potentially important new drug candidate for treating acute agitation."

"The clinical data we have seen to date, in terms of both efficacy and side-effect profiles, are compelling," said Michael H. Allen, MD, Director of Research, University of Colorado Depression Center. "There is a significant unmet medical need to treat acute agitation with ne
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