NUPLAZID® (pimavanserin) was approved by the FDA based on data from clinical trials in people with Parkinson's disease (PD)–related hallucinations and delusions.
A pivotal trial supported the efficacy and safety of NUPLAZID. The NUPLAZID clinical development program included multiple supportive trials, with over 1200 people receiving NUPLAZID. These include 616 people with PD-related hallucinations and delusions. In an open-label safety extension study, more than 270 people with PD-related hallucinations and delusions had received treatment for over 1 year, and more than 150 people for at least 2 years.
Pivotal trial details:
In a 6-week, placebo-controlled trial, NUPLAZID significantly reduced the frequency and/or severity of hallucinations and delusions versus placebo. The trial included 199 adults, at least 40 years of age with an average age of 72 years, with Parkinson's disease psychosis severe enough to require treatment.