www.fdanews.com/articles/173954-acadia-wins-fda-priority-review-for-psychosis-drug
Acadia Wins FDA Priority Review for Psychosis Drug
November 6, 2015
The FDA has granted priority review to Acadia Pharmaceuticals’ Nuplazid for the treatment of psychosis associated with Parkinson’s disease. A PDUFA date has been set for May 1, 2016.
The NDA submission includes data from a pivotal Phase 3 study that showed improvement in both primary and secondary endpoints with no worsening of motor function.
Nuplazid (pimavanserin) acts as a selective serotonin inverse agonist that targets 5-HT2A receptors.