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Monday 03 July 2006

Alexza initiates AZ-001 phase IIb trial in patients with migraine headaches

By: NewsRx

Alexza Pharmaceuticals, Inc., (ALXA) announced that it has initiated a phase IIb clinical trial with AZ-001 (Staccato prochlorperazine) in patients with migraine headaches. AZ-001 is an inhalation product candidate being developed for the acute treatment of migraine headaches.

The phase IIb clinical trial is an outpatient, multi-center, randomized, double-blind, single-dose, placebo-controlled study in approximately 400 migraine patients with or without aura. Four doses will be evaluated in the clinical trial, placebo and three doses of AZ-001 (5, 7.5 and 10 mg). Using the International Headache Society (IHS) 4-point rating scale, the primary efficacy endpoint for the trial is headache pain relief at 2 hours post-dose. Secondary efficacy endpoints for the trial include pain relief and other symptom assessments at various time points. Safety evaluations will also be made throughout the clinical trial period.

"This clinical trial with AZ-001 in migraine patients is our first study with a Staccato product candidate in a non-clinical setting," said Thomas B. King, Alexza president and CEO. "We believe the potential value of the non- invasive nature and rapid onset of pharmacological action provided by our Staccato system is well-suited for migraine pain relief in the outpatient setting. Data from this important clinical trial will guide us in our future development of AZ-001 for the treatment of migraine headaches."

According to the National Headache Foundation, approximately 13 million people in the United States have been diagnosed with migraine headaches. Acute migraine headaches occur often, averaging one to four times a month. The company believes that many migraine patients desire to find faster-acting and more predictable therapies for the treatment of their migraine headaches.

AZ-001 combines Alexza's proprietary Staccato system with prochlorperazine, a drug belonging to the class of compounds known as phenothiazines. Prochlorperazine is currently approved in the United States for the treatment of several indications, including nausea and vomiting. In several published clinical studies, 10 mg of prochlorperazine administered intravenously demonstrated effective relief of migraine pain. The company believes that AZ-001 could potentially result in a speed of therapeutic onset advantage over oral tablets, and a convenience and comfort advantage over injections.

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