December 26, 2012
Adasuve Approved for Agitation Associated with Schizophrenia or Bipolar I Disorder
The FDA approval is based on two Phase 3 trials that evaluated more than 1,600 patients. Clinical data showed Adasuve was found to be effective in the acute treatment of agitation in adults with schizophrenia or bipolar I disorder. In these two studies, Adasuve 10mg met the primary efficacy endpoint, with statistically significant reductions in agitation as compared to placebo at the two-hour post-dose time point, as well as the principal secondary endpoint. Adasuve also showed rapid effects in agitated patients, with statistically significant reductions in agitation apparent starting at 10 minutes following administration of a dose vs. placebo.
Adasuve will be available as single-use disposable inhalers containing 10mg loxapine in 5-unit cartons. It is expected to be available in the third quarter of 2013.
For more information call (800) 284-0062 or visit www.adasuve.com.