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news.Alexza Pharmaceuticals has completed patient enrollment in its phase IIa trial of its inhalation product candidate being developed for the treatment of agitation in schizophrenic patients.
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The phase IIa trial examined two doses of AZ-004, 5 and 10 mg, and placebo. The primary aim of the trial was to assess the safety and efficacy of a single dose of AZ-004 in acutely treating agitation in schizophrenic patients.
“This clinical trial is significant in demonstrating that acutely-agitated schizophrenic patients can self-administer AZ-004 in a clinical setting,” said James Cassella, Alexza senior vice president of R&D.
“We completed enrollment in this proof-of-concept study in less than four months, which we believe shows the viability of this treatment option in this patient population. We believe we are on track to provide initial results from this clinical trial during the second quarter of 2007.”
AZ-004 is the combination of Alexza's proprietary staccato system with loxapine, a drug belonging to the class of compounds known as antipsychotics. Alexza believes the non-invasive nature and rapid pharmacokinetic properties resulting from administration via the staccato system make AZ-004 a viable product candidate for treating agitation episodes in schizophrenic patients.