Alexza's AZ-104 (Staccato(R) Loxapine) Phase 2a Trial Meets Primary Endpoint of 2-Hour Pain Relief in Patients with Migrain...(of theSymphony Allegro Development Board...),Health

AZ-104 Phase 2a Clinical Trial Design

The Phase 2a clinical trial was an in-clinic, multi-center, randomized, double blind, placebo-controlled study. The study was designed to evaluate the treatment of a single migraine attack in each of 160 migraine patients, with or without aura. In the trial design, three doses of AZ-104 (Staccato loxapine in 1.25, 2.5 and 5 mg doses) were evaluated against placebo (a Staccato device containing no drug). Patients reported to the clinic when they felt the onset of a migraine and were treated once their headache was considered to be of moderate or severe intensity. Patients stayed in the clinic for 4 hours post-dosing for various assessments and were monitored via patient diary for the remainder of the 24-hour evaluation period. The clinical trial enrolled 168 patients: 43 patients in the 1.25 mg dose group, 43 patients in the 2.5 mg dose group, 43 patients in the 5 mg dose group and 39 patients in the placebo dose group.

Patients rated their headache pain using the International Headache Society (IHS) 4-point rating scale. The primary efficacy endpoint was headache pain relief (headache pain rated as mild or none) at 2-hours post-dose. Secondary efficacy endpoints for the trial included various additional measurements of pain relief, as well as effects on nausea, vomiting, phonophobia and photophobia. All results were considered statistically significant at the p < 0.05 level and all analyses were made on an intent-to-treat basis. Side effects were recorded throughout the clinical trial study period.

Primary Efficacy Endpoint

AZ-104 met the primary efficacy endpoint of the clinical trial for two doses of the drug compared to placebo. Statistically
'/>"/>