Alexza Initiates Second Phase III Clinical Trial for AZ-004

Alexza Pharmaceuticals has begun its second Phase III trial with AZ-004, an inhalation product being developed for the treatment of acute agitation in patients with schizophrenia or bipolar disorder.

Acute agitation, characterized by unpleasant arousal, tension, irritability and hostility, is one of the most common and severe symptoms of major psychiatric disorders. This is the first study with AZ-004 to enroll bipolar disorder patients, Alexza said.

The trial will take place at 18 U.S. clinical centers and is expected to enroll roughly 300 patients with bipolar I disorder and acute agitation over 12 months. The candidate is a combination of the company’s Staccato system with loxapine, an antipsychotic.