Alexza Pharmaceuticals (Alexza) has submitted its New Drug Application (NDA) for Staccato loxapine (AZ-004) to the FDA. AZ-004 is an inhalation product candidate being developed for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder.
The IND for Staccato loxapine was filed with the FDA in August 2005.
Reportedly, the AZ-004 NDA contains efficacy and safety data from more than 1600 patients and subjects who have been studied in 13 different clinical trials. In 2008, the company successfully initiated and completed two pivotal Phase 3 clinical trials.
The company said that in these studies, both doses of AZ-004 (5 and 10mg) met the primary and key secondary endpoints of the studies, with significant reductions in agitation as compared to placebo.
James Cassella, senior vice president of research and development at Alexza, said: “AZ-004 has delivered a predictable and consistent safety and efficacy profile in treating patients with agitation. We believe that AZ-004, if approved, has the potential to change the treatment practices for acute agitation, as the only product able to meet both the patients’ desire for quickly and comfortably gaining control, and the clinicians’ goal of rapidly and reliably calming an agitated patient.”