Alexza Pharmaceuticals Announces Results of Migraine Trial

Alexza Pharmaceuticals announced positive top-line results from its 400-patient Phase IIb clinical trial of AZ-001 (Staccato prochlorperazine) in patients with migraine headache. All three doses of AZ-001 met the primary endpoint of two-hour pain relief compared with placebo.

The AZ-001 Phase IIb clinical trial was an outpatient, multicenter, randomized, double-blind, placebo-controlled study. The study was designed to evaluate the treatment of a single migraine attack in each of 400 migraine patients, with and without aura. In the trial, three doses of AZ-001 (5, 7.5 and 10 mg) and placebo (a Staccato device containing no drug) were tested, with 100 patients assigned to each treatment group. The primary efficacy endpoint for the trial was headache pain relief at two hours post-dose, as defined by the International Headache Society using a four-point headache pain rating scale. Secondary efficacy endpoints for the trial included various additional measurements of pain relief, as well as effects on nausea, vomiting, phonophobia and photophobia.

AZ-001 met the primary efficacy endpoint of the trial for all three doses of the drug. Statistically significant improvements in pain response were observed in 66 percent of patients at the 10-mg dose, 63.7 percent of patients at the 7.5-mg dose and 60.2 percent of patients at the 5-mg dose, compared with 40.8 percent of patients receiving placebo.

Another measure of efficacy was the achievement of a pain-free response at two hours. In the trial, AZ-001 showed statistically significant differences from placebo in this measure with 35 percent of patients who received the 10-mg dose achieving pain-free status and 29.7 percent of patients who received the 7.5-mg dose achieving pain-free status. The rate of pain-free response at two hours in patients receiving placebo was 15.3 percent.