Alexza starts Ph III loxapine trial

California, USA-based Alexza Pharmaceuticals has initiated a first Phase III clinical trial with AZ-004 (Staccato; loxapine), an inhalation product candidate being developed for the treatment of acute agitation in patients with schizophrenia or bipolar disorder. The company believes the novel, non-invasive nature and rapid pharmacokinetic (PK) properties resulting from inhaled loxapine administration via the Staccato system have the potential to make AZ-004 a viable product to treat acute agitation. AZ-004 is being developed through Symphony Allegro, a product development partnership formed between Alexza and Symphony Capital.

Thomas King, Alexza's chief executive, says that "the results we have seen to date with AZ-004 have been promising and we look forward to enrolling the planned Phase III clinical trials as quickly as possible. This is a transitional year in our history as we move into the early commercial planning for the manufacturing, regulatory submissions, and potential sales and marketing of AZ-004."

The first AZ-004 Phase III clinical trial is designed to enroll around 300 schizophrenic patients with acute agitation at 25 US clinical centers. The study is an in-clinic, multicenter, randomized, double-blind, placebo-controlled evaluation and will test AZ-004 at two dose levels, 5mg and 10mg. Patients may receive up to three doses of the study drug in a 24-hour period, depending on their clinical status. The primary endpoint is the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component (also known as PEC) score, measured at two hours after the first dose. A second Phase III clinical trial is projected to begin in the third quarter.