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

Alexza Pharmaceuticals, Inc. 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.

About Acute 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, usually one to four times a month. Of the estimated 29.5 million migraine sufferers (including diagnosed and undiagnosed sufferers), there are at least two groups of potential patients
for whom we believe AZ-001 (Staccato prochlorperazine) and AZ-104 could be effective and safe in comparison to triptans. Many migraine sufferers who do take triptans have an insufficient therapeutic response to these medications. In addition, according to the warning labels on triptans, patients with hypertension or high cholesterol, or who smoke cigarettes, are contraindicated for and should not take these medications due to potential cardiovascular health risks.

For more information, visit mymigraineconnection.com

Educating patients to control migraine

When migraine patients trained other migraine patients how to prevent migraine headaches, attacks declined and both trainers and trainees gained a greater sense of control over their attacks, researchers report.

Patient-trainers provide credible and recognizable disease-specific knowledge, Dr. Jan Passchier told Reuters Health. "Trainees appreciated the trainers' emotional and motivational assistance."

Moreover, trainers themselves benefited "in terms of large headache improvements and improved quality of life," noted Passchier, of Erasmus University Medical Centre in Rotterdam, the Netherlands.

Passchier and colleagues evaluated the effects of migraine sufferers providing other migraine sufferers with home-based behavior training. Both trainers and trainees were under medical care for relatively frequent migraine (1 to 6 times per month), with or without aura, but had no underlying associated disease, the investigators explain in the journal Cephalalgia.

Passchier's team recruited trainers from a pool of patients who took behavioral training classes themselves. The 14 trainers were educated in how to train others to detect and modify their individual migraine triggers and use relaxation and breathing exercises, as well as other behavioral techniques to prevent attacks.

Patients reporting greater numbers of migraines appeared to benefit more from training than did those with less frequent attacks, the researchers report.

Moreover, patients receiving behavioral training reported significantly increased self-confidence in their own ability to prevent migraine attacks, and a greater ability to manage and control attacks.

For more information, visit mymigraineconnection.com