SSIA Nuplazid (pimavanserin) met its endpoint for time to patient relapse; Acadia is expected to file for an sNDA in 2020.
According to drug developer Acadia Pharmaceuticals, approximately 8 million Americans have some form of dementia (Alzheimer’s disease, dementia with Lewy bodies, Parkinson’s disease dementia, vascular dementia and frontotemporal dementia). Nearly a third of those patients also suffer from psychosis (experience delusions and hallucinations). The U.S. Food and Drug Administration (FDA) has yet to approve a medication for the treatment of dementia-related psychosis (DRP).
San Diego-based Acadia is hoping it will be the first company to receive FDA approval for such a drug. A phase III clinical trial in DRP with its selective serotonin inverse agonist (SSIA) Nuplazid (pimavanserin), which has already received approval by the agency for the treatment of Parkinson’s disease psychosis, was halted early by the company because it provided sufficient positive data at an interim readout.
More details will be provided at a medical conference sometime in the near future. Acadia is expected to file a supplemental New Drug Application with the FDA next year. The company reportedly has an agreement with the agency that a single well-controlled trial with “statistically persuasive” results would be sufficient to gain approval.