Alexza’s migraine drug meets endpoint in Phase II trial

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.