Nuplazid(pimavanserin)

Nuplazid (pimavanserin) is an atypical antipsychotic, specifically a Serotonin receptor 2A (5-HT2A) inverse agonist, approved by the FDA on April 29, 2016. It is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis (PDP), for which there were no previously FDA-approved drug treatments. The recommended dose is 34 mg, or 10 mg when co-administered with strong CYP3A4 inhibitors.

In clinical trials, pimavanserin demonstrated an improvement in psychotic symptoms over placebo, with a 23.1% improvement in SAPS-PD and a 23.3% improvement in CGI-I responder difference. The mean difference from placebo in SAPS-PD was 3.06 points. The median SAPS-PD change for much improvement (CGI-I=2) was 7 points.

Safety findings indicate that 7.9% of subjects on pimavanserin 34mg experienced serious adverse events (SAEs) compared to 3.5% on placebo. Discontinuation due to adverse events was 9.5% for pimavanserin 34 mg QD subjects versus 2.1% for placebo subjects. The risk for SAEs for pimavanserin 34mg versus placebo was 2.38.