Alexza Pharmaceuticals's AZ-001 Phase IIb Trial Meets Primary Endpoint of 2-Hour Pain Relief in Patients With Migraine Headache
PALO ALTO, Calif., March 26 -- Alexza Pharmaceuticals, Inc. today 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 2-hour pain-relief, compared to placebo. Alexza also announced today positive initial results from its Phase IIa clinical trial of AZ-004 (Staccato loxapine) in schizophrenic patients with acute agitation, where AZ-004 met the primary endpoint of the Phase IIa clinical trial.
"AZ-001 is a product candidate that we believe could fill an important unmet need in the treatment of patients with migraine headaches," said Thomas B. King, President and CEO of Alexza. "AZ-001 combines drug delivery speed comparable to that of an intravenous injection, with the simplicity, convenience and ease of administration of a simple, one-breath inhalation. For the second time in Phase II trials, efficacy has been established for AZ-001, this time with dose-ranging information."
"Prochlorperazine has long been administered intravenously with significant success in treating migraine headaches, usually in a clinic or in an emergency department," said Anthony W. Fox, MD, PhD, President of the EBD Group and advisor to Alexza. "The ability to provide a therapy with an alternative mechanism of action, coupled with rapid pharmacokinetics in an outpatient environment, makes Staccato prochlorperazine an exciting drug candidate for many migraine patients."
Clinical Trial Design
The AZ-001 Phase IIb clinical trial was an outpatient, multi-center, 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 (Staccato prochlorperazine in 5, 7.5 and 10 mg doses) 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 2-hours post-dose, as defined by the International Headache Society (IHS) using a 4-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. The clinical trial study period was 24 hours post dosing for each patient. All results were considered statistically significant at the p