Acadia Submits Nuplazid NDA for Psychosis in Parkinson’s

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If approved, Nuplazid will be the first drug approved to treat psychosis in Parkinson's disease.

Acadia Pharmaceuticals, based in San Diego, Calif. has submitted a new drug application to the FDA for Nuplazid (pimavanserin) for the treatment of Parkinson’s disease (PD) psychosis. Currently, no other psychosis treatments are approved for use in Parkinson’s disease.

Nuplazid is a selective serotonin inverse agonist (SSIA) that targets 5-HT2A receptors. Safety and efficacy was demonstrated throughout the Phase III -020 Study, in which Nuplazid met all primary and secondary endpoints with statistical significance, as well through supportive studies. In the Phase III -020 Study, Nuplazid significantly reduced psychosis compared to placebo in patients with PD psychosis, with no ill effect on motor function. Treatment with Nuplazid also showed benefits for nighttime sleep, daytime wakefulness and caregiver burden.

“Psychosis is the leading cause for Parkinson’s patients moving from their homes to nursing homes or other institutions and leads to an increased risk of mortality, a diminished quality of life and significant caregiver burden,” said Acadia CEO Steve Davis. “If approved, Nuplazid would represent a new and distinctly different pharmacological approach to treating psychosis and would be the first drug approved in the United States for psychosis associated with Parkinson’s disease.”

Previously granted breakthrough therapy designation by the FDA in 2014, Acadia is now requesting a priority review of its NDA.

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