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Alexza's Migraine Drug Meets Endpoint in Phase II Trial

Posted on: Tuesday, 4 March 2008, 09:01 CST

Alexza Pharmaceuticals has reported positive top-line results from its 168 patient Phase IIa trial of AZ-104 or Staccato loxapine in patients with migraine headache.

Two doses of AZ-104, 2.5 and 5mg, met the primary endpoint of two-hour pain-relief compared to placebo. The company has said that statistically significant improvements in pain response were observed in 76.7% of patients at the 5mg dose (p = 0.02), 79.1% of patients at the 2.5mg dose (p = 0.01) and 67.4% of patients at the 1.25mg dose (p = 0.18), compared to 51.3% of patients receiving placebo.

Using survival analysis for pain relief response, all three dose groups were statistically superior to placebo during the four-hour post-treatment time period that the patients remained in the clinic.


Source: Datamonitor

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