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."