Alexza (ALXA) Announces Preliminary Results from its AZ-104 Phase 2b Trial in Patients with Migraine Headache

September 14, 2009 8:13 AM EDT
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Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced preliminary results from its 366 patient Phase 2b clinical trial of AZ-104 in patients with migraine headache. Both AZ-104 dose groups trended towards statistical significance, but the study did not meet its primary endpoint, which was defined as pain-relief at the 2-hour time point, compared to placebo. There were no serious adverse events in the clinical trial, and AZ-104 was generally safe and well tolerated in this patient population.

"The failure to reach statistical significance on the primary endpoint is disappointing, as we were not able to reproduce the positive clinical findings from our AZ-104 Phase 2a proof-of-concept clinical trial," said James V. Cassella, PhD, Senior Vice President, Research and Development at Alexza.

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