Alexza Pharmaceuticals, Inc announced positive results from its second phase-3 clinical trial of AZ-004 (Staccato loxapine). This phase-3 clinical trial was conducted in patients with bipolar disorder experiencing 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 two-hour post-dose time point, compared to placebo. AZ-004 is an inhalation product candidate being developed for the acute treatment of 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 this second phase-3 clinical trial of our lead programme in late July, completed enrolment in less than three months, and now we are reporting positive top-line results for the primary and secondary endpoints," said James V Cassella, Alexza senior vice president, Research and Development. "These very strong results -- coupled with the positive data from our first Phase 3 trial in schizophrenic patients -- reinforce our belief that AZ-004 is a potentially important new drug candidate for treating acute agitation. Loxapine is a well established antipsychotic and the Staccato system enables patients to easily and painlessly self-administer the drug with a single breath and achieve therapeutic effect as quickly as an intravenous injection -- a combination of attributes that makes AZ-004 a unique potential therapeutic alternative for the acute treatment of agitation. We look forward to taking the next steps toward preparing an NDA for submission in early 2010."

"The positive results from this second phase-3 study, corroborating our first phase-3 findings, show that AZ-004 has the potential to be a viable product to acutely treat agitation," said Thomas B King, Alexza president and CEO. "We are very encouraged with the pace at which we have developed into a pre-NDA stage company. In addition to our clinical successes, we are aggressively escalating many commercialization activities, including our commercial manufacturing scale-up, quality systems, regulatory affairs and strategic marketing initiatives, as we continue to track toward our planned AZ-004 NDA submission in early 2010."

AZ-004 is the combination of Alexza's proprietary Staccato system with loxapine, a drug belonging to the class of compounds known generally as antipsychotics.

Alexza Pharmaceuticals is an emerging specialty pharmaceutical company focused on the development and commercialization of novel, proprietary products for the treatment of acute and intermittent conditions.