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Alexza's AZ-104 (Staccato(R) Loxapine) Phase 2a Trial Meets Primary Endpoint of 2-Hour Pain Relief in Patients with Migraine Headache
Date:3/3/2008

Initial Analysis Shows Statistically Significant Pain Relief with the 2.5

and 5 mg Doses Compared to Placebo

MOUNTAIN VIEW, Calif., March 3 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today positive top-line results from its 168 patient Phase 2a clinical trial of AZ-104 (Staccato(R) loxapine) in patients with migraine headache. Migraine is a debilitating, yet common neurological disorder characterized by attacks of severe headache and autonomic nervous system dysfunction. Two doses of AZ-104, 2.5 and 5 mg, met the primary endpoint of 2-hour pain-relief compared to placebo. Alexza believes the novel, non-invasive nature and rapid pharmacokinetic (PK) properties resulting from inhaled loxapine administration via the Staccato system have the potential to make AZ-104 a viable product to treat acute migraines. AZ-104 is a lower dose version of AZ-004, which is in Phase 3 clinical development for the treatment of acute agitation in patients with schizophrenia or bipolar disorder. AZ-004 and AZ-104 are being developed through Symphony Allegro, a development collaboration formed between Alexza and Symphony Capital in 2006.

"Loxapine is a potent antagonist at dopamine D2 receptors as well as serotonergic 5-HT2A receptors. While drugs that antagonize the D2 receptor are efficacious in treating migraine, it was proposed that the 5HT2A receptor antagonism might yield an improved adverse effect profile over drugs blocking primarily the D2 receptor. This dual mechanism of pharmacological action provided the scientific rationale to study AZ-104 in this proof-of-concept clinical trial," said James V. Cassella, PhD, Senior Vice President, Research and Development at Alexza and chairman
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SOURCE Alexza Pharmaceuticals, Inc.
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