NUPLAZID (pimavanserin) Efficacy Data from Open-Label Extension (OLE) Study Published in Parkinsonism and Related Disorders

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced publication of open-label extension (OLE) data from patients experiencing hallucinations and delusions associated with Parkinson’s disease psychosis (PDP) who had previously completed one of three, six-week, double-blind, placebo-controlled studies.

The OLE efficacy analysis showed that patients previously on NUPLAZID 34 mg had a sustained efficacy response from Week 6 through Week 10, and that patients who had been treated with investigational doses of 8.5 mg and 17 mg or placebo also showed an improvement in the symptoms of psychosis when switched to NUPLAZID 34 mg over the 4 weeks of the OLE. The completed study was published online and in the June issue of Parkinsonism and Related Disorders. Full text of the paper can be found at: https://www.prdjournal.com/article/S1353-8020(21)00145-0/fulltext.

“Results from a multi-center OLE study, across 14 countries, demonstrate the extended durability of efficacy of NUPLAZID for treating hallucinations and delusions associated with PDP, in addition to reinforcing the efficacy seen in the original pivotal trial using the 34 mg dose,” said Stuart Isaacson, M.D., Director, Parkinson’s Disease and Movement Disorders Center of Boca Raton. “As a physician, having NUPLAZID, an FDA-approved and proven therapy to treat these debilitating symptoms without impairing motor function, represents a major step forward. NUPLAZID is a critical first-line therapy for our patients living with PDP, and their caregivers.”

Importantly, non-motor symptoms of Parkinson’s disease, including hallucinations and delusions, can be more troublesome than motor symptoms.¹ Hallucinations and delusions can also worsen over time, making it difficult for patients to know whether or not what they are experiencing is real.^2,3

“We’re pleased to have additional published data supporting the efficacy of NUPLAZID, as approximately 50 percent of people living with Parkinson’s may experience hallucinations and delusions during the course of their disease,” said Ponni Subbiah, M.D., M.P.H., Senior Vice President, Global Head of Medical Affairs and Chief Medical Officer at Acadia. “These symptoms can have a significant impact on both patients and their families, negatively impacting their quality of life and causing severe emotional distress.”