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ACADIA Pharmaceuticals Submits Supplemental New Drug Application to U.S. FDA for NUPLAZID® (pimavanserin) for the Treatment of Hallucinations and Delusions Associated with Dementia-Related Psychosis
- Submission based on positive results from the Phase 3 HARMONY study which showed a statistically significant 2.8 fold reduction in the risk of relapse of
About this update from Acadia Pharmaceuticals Inc.
[{"type":"text","content":"\n- Submission based on positive results from the Phase 3 HARMONY study which showed a statistically significant 2.8 fold reduction in the risk of relapse of psychosis\n\n SAN DIEGO--(BUSINESS WIRE)--\nACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) announced today that the company submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to support a potential new indication for NUPLAZID® (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). The FDA previously granted Breakthrough Therapy Designation for pimavanserin for the treatment of hallucinations and delusions associated with DRP.\n\n\n“This is an important step forward for the approximately 2.4 million people in the U.S. who suffer from dementia-related hallucinations and delusions, representing a large unmet need with currently no approved treatment options,” said Steve Davis, ACADIA’s Chief Executive Officer. “Our pivotal HARMONY study showed a meaningful reduction of the symptoms and stabilization of psychosis and a nearly three-fold reduction in the risk of relapse of psychosis for patients continuing treatment on pimavanserin compared to placebo. We look forward to working with the FDA as it reviews our submission.”\n\n\nThe sNDA is supported by results from the pivotal Phase 3 HARMONY study, which met its primary endpoint, demonstrating that pimavanserin significantly reduced the risk of relapse of psychosis by 2.8 fold compared to placebo (hazard ratio = 0.353; one-sided p=0.0023). The sNDA also includes positive efficacy results from two additional placebo-controlled studies, both of which met their respective primary endpoints: The Phase 2 (-019) study in patients with Alzheimer’s disease psychosis and the Phase 3 (-020) study in patients with Parkinson’s disease psychosis. The sNDA includes a large safety and tolerability database from completed and ongoing studies representing over 1500 patients with neurodegenerative disease.\n\n\nDementia is highly prevalent, affecting approximately 8 million people in the U.S., and is only expected to grow as the population ages. Approximately 30 percent, or 2.4 million people, experience dementia-related psychosis and only half, or 1.2 million, are diagnosed and treated1,2.\n\n\nNUPLAZID was approved in the U.S. in 2016 as the...