The primary aim of the clinical trial was to assess the safety and efficacy of a single dose of AZ-004 in acutely treating agitation in schizophrenic patients.
In the phase IIa study three doses of the inhaled drug were studied. The 10mg dose of the drug AZ-004 met the primary endpoint of the clinical trial, which was a statistically-significant reduction in the measure of agitation compared to placebo. The lower 5mg dose did not achieve statistical significance. Alexza also said that all three doses significantly reduced migraine pain after two hours compared with placebo
“AZ-004 combines drug delivery speed comparable to that of an intravenous injection, but with the simplicity, convenience and ease of administration of a simple, one-breath inhalation,” said Thomas King, president and CEO of Alexza.