The company said that the failure to meet the two primary endpoints was the effect of AZ-002 on the incidence of a doxapram-induced panic attack and the effect of AZ-002 on the duration of a doxapram-induced panic attack, both as compared with placebo. There were no serious adverse events in the clinical trial, and AZ-002 was safe and well tolerated in the study patient population.
The AZ-002 Phase IIa clinical trial was an in-clinic, randomized, double-blind, placebo-controlled proof-of-concept evaluation of patients with panic disorder. After an open-label pilot phase, 40 patients were enrolled at three US clinical centers, with 20 patients receiving 1mg AZ-002 and 20 patients receiving Staccato placebo. The primary aim of the clinical trial was to assess the safety and efficacy of a single dose of AZ-002 in treating a pharmacologically induced panic attack.
James Cassella, senior vice president of R&D at Alexza, said: “The failure to reach statistical significance on the primary endpoints is disappointing, but this proof-of-concept clinical trial was designed to capture data and measurements for a number of clinical parameters in this clinical setting.”