June 16, 2008
Alexza reported negative results from a phase IIa trial of AZ-002 (Staccato alprazolam) for the treatment of panic disorder. This randomized, double-blind, placebo-controlled study enrolled 40 subjects in the US. Following an open label phase, the subjects received a Staccato device (randomized to either 1 mg AZ-002 or placebo) and an intravenous administration of doxapram, a respiratory stimulant used to induce a simulated panic attack. The co-primary endpoints were to assess the effect of treatment on the occurrence of a doxapram-induced panic attack of sufficient intensity and to assess the effect of treatment on the duration of the doxapram-induced panic attack. Data was based on the Acute Panic Inventory, a 22-item self-report questionnaire. The trial failed to reach statistical significance on both primary endpoints. AZ-002 was safe and well tolerated and no serious adverse events were reported. Alexza plans to further analyze the data in order to determine a future course of action.