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.