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news.Alexza Pharmaceuticals has completed enrollment of its first Phase III clinical trial with AZ-004, an inhalation product candidate being developed for the treatment of acute agitation in patients with schizophrenia or bipolar disorder.
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Alexza said that the novel, non-invasive nature and rapid pharmacokinetic 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 in 2006.
Thomas King, president and CEO of Alexza, said: “With the early completed enrollment of our first AZ-004 Phase III study, we are sharpening our focus and accelerating our AZ-004 pre-commercialization activities for manufacturing, quality systems, regulatory submissions, and potential sales and marketing. We also remain on schedule to initiate our second AZ-004 Phase III study during the third quarter of this year.”