Alexza has added that improvement in agitation levels were observed as early as 10 minutes after dosing on the standard components of agitation as measured by the Positive and Negative Syndrome Scale – Excited Component (PEC).
Staccato loxapine also had no significant hemodynamic effect in subjects taking chronic antipsychotic treatment and did not significantly prolong the QT interval at therapeutic doses.
These and other efficacy and safety data from clinical trials involving more than 700 patients and subjects were presented in poster presentations at the Annual Scientific Sessions of the American Psychiatric Association meeting in New Orleans.
Staccato loxapine is being developed by Alexza Pharmaceuticals for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder. Agitation is distressing for patients and their caregivers as well as a challenge for health-care professionals to manage.
According to Alexza, an AZ-004 new drug application is currently under review by the US FDA, with a PDUFA goal date of October 11, 2010. The studies being reported were sponsored by Alexza, and the AZ-004 rights for the treatment of psychiatric and/or neurological indications and the symptoms associated with these indications have been licensed in the US and Canada to Biovail Laboratories International, SRL, a subsidiary of Canada-based Biovail.
James Cassella, senior vice president of research and development at Alexza Pharmaceuticals, said: “As previously reported, our Phase 3 studies showed that Staccato loxapine was effective in relieving the symptoms of agitation, with an onset of effect occurring in as little as 10 minutes. Additional analyses of our Phase 3 data show that AZ-004 rapidly treated the five individual dimensions of agitation in patients with schizophrenia or bipolar disorder.”