MOUNTAIN VIEW, Calif., Feb. 25 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has initiated its first Phase 3 clinical trial with AZ-004 (Staccato(R) loxapine). AZ-004 is an inhalation product candidate being developed for the treatment of acute agitation in patients with schizophrenia or bipolar disorder. Alexza 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, LLC.
"We are excited to be initiating our AZ-004 NDA plan with this first Phase 3 clinical trial," said Thomas B. King, Alexza President and CEO. "The results we have seen to date with AZ-004 have been promising and we look forward to enrolling the planned Phase 3 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."
AZ-004 Phase 3 Clinical Trial Design
The first AZ-004 Phase 3 clinical trial is designed to enroll approximately 300 schizophrenic patients with acute agitation at 25 U.S. clinical centers. The trial is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study and will test AZ-004 at two dose levels, 5 and 10 mg. Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status.
The primary endpoint for the study is the change from baseline in the
PANSS (Positive and
|SOURCE Alexza Pharmaceuticals, Inc.|
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