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Alexza Pharmaceuticals (ALXA) Initiates AZ-104 Phase 2b Clinical Trial in Patients With Migraine Headaches

January 20, 2009 5:37 PM EST
ALXA Hot Sheet
Overall Analyst Rating:
    NEUTRAL (Up Up)

Revenue Growth %: +49.2%
Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced that it has initiated a Phase 2b clinical trial with AZ-104 (Staccato loxapine) in patients with migraine headaches. AZ-104 is a lower-dose version of AZ-004 (Staccato loxapine), Alexza's lead product candidate that is in late Phase 3 clinical development for the acute treatment of agitation in patients with schizophrenia or bipolar disorder. The Company has previously announced positive results in two Phase 3 trials of AZ-004 and expects to submit a New Drug Application for AZ-004 in early 2010. AZ-104 and AZ-004 are being developed through Symphony Allegro, a product development partnership formed between Alexza and Symphony Capital, LLC.

In March 2008, the Company announced positive initial results of an in-clinic, multi-center, randomized, double-blind, single administration, placebo-controlled Phase 2a proof-of-concept clinical trial in 168 migraine patients with or without aura.

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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.

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