Phase 3 trial of AZ-004 for the treatment of agitation associated with schizophrenia

Alexza announced results from its Phase 3 study of AZ-004 for the rapid treatment of agitation associated with schizophrenia. The randomized, double-blind, placebo-controlled, parallel-group study conducted in 24 U.S. clinical centers, enrolled 344 patients with schizophrenia experiencing agitation.  Patients received one, two or three doses of AZ-004 (5 or 10 mg) or a placebo.  

The primary efficacy end-point of this study was change from baseline in PANSS (Positive and Negative Syndrome Scale) Excited Component score (also known as PEC score), measured at two hours after the first dose of study medication. The key secondary end-point in the study was the Clinical Global Impression–Improvement scale (CGI–I) score, measured at two hours after the first dose of study medication. Results of the study demonstrated that AZ-004 (both 5 and 10 mg) provided a statistically significant reduction in agitation compared to placebo, as assessed by the primary and key secondary end-points.

AZ-004 (loxapine) is being developed for the rapid treatment of agitation in schizophrenic or bipolar disorder patients.  AZ-004 utilizes Alexza's Staccato system, that vaporizes unformulated drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery through deep lung inhalation.

For more information call (650) 944-7000 or visit www.alexza.com.