ACAD > news: FDA Issues Statement Reaffirming the Positive Benefit-Risk Profile of NUPLAZID(R) (pimavanserin) for Patients with Hallucinations and Delusions Associated with Parkinson's Disease Psychosis
5:15 pm ET September 20, 2018 (BusinessWire) Print
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) today announced that the FDA has completed a postmarketing review and issued a clear statement reaffirming the positive benefit-risk profile of NUPLAZID (pimavanserin) for patients with Parkinson's disease psychosis. NUPLAZID is the only medicine approved in the United States to treat hallucinations and delusions associated with Parkinson's disease psychosis (PDP). NUPLAZID was approved by the FDA based on a pivotal Phase 3 study that demonstrated clinically robust and highly statistically significant efficacy, combined with other supportive studies.
Following the FDA's review, the FDA concluded, "The U.S. FDA has completed a review of all postmarketing reports of deaths and serious adverse events (SAEs) reported with the use of NUPLAZID. Based on an analysis of all available data, FDA did not identify any new or unexpected safety findings with NUPLAZID, or findings that are inconsistent with the established safety profile currently described in the drug label. After a thorough review, FDA's conclusion remains unchanged that the drug's benefits outweigh its risks for patients with hallucinations and delusions of Parkinson's disease psychosis." In addition, the FDA stated that, "patients taking NUPLAZID for Parkinson's disease psychosis should continue to use it as prescribed by their health care providers. Based on this observation, FDA reminds health care providers to be aware of the risks described in the prescribing information. FDA also reminds health care providers that none of the other antipsychotic medications are approved for the treatment of Parkinson's disease psychosis."
"Nothing is more important to ACADIA than the wellbeing of the patients who use NUPLAZID. We are very pleased with the FDA's clear statement reaffirming NUPLAZID's positive benefit-risk profile," said Steve Davis, ACADIA's President and Chief Executive Officer. "We are also pleased with the FDA's conclusion that patients taking NUPLAZID for Parkinson's disease psychosis should continue to use it as prescribed by their health care provider and its reminder that no other antipsychotic medication is approved for the treatment of PDP."
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