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news.Alexza Pharmaceuticals expects to begin the first of two Phase III trials for Staccato loxapine late in the first quarter of 2008. It is initially being developed for the treatment of acute agitation in patients with schizophrenia or bipolar disorder.
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The two Phase III trials are anticipated to each enroll approximately 300 patients. AZ-004 is being developed through Symphony Allegro, a product development collaboration formed between Alexza and Symphony Capital.
Thomas King, president and CEO said: “Our AZ-004 development program continues to track 6 to 12 months ahead of our original schedule, which we outlined last September as we initiated our phase IIa clinical trial. We believe that the strength of the clinical data from our phase IIa clinical trial, coupled with the speed with which that trial enrolled, has put us in position to initiate our phase III trials significantly ahead of our original plans. AZ-004 is a product candidate we believe could fill an important unmet need in the acute treatment of agitation in schizophrenic and bipolar patients.”