www.fdanews.com/articles/173954-acadia-wins-fda-priority-review-for-psychosis-drug
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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.