With pimavanserin's Phase 3 failure in schizophrenia, Acadia Pharmaceuticals said it will no longer run clinical trials for the drug, whose lone approval is for treating psychosis from Parkinson's disease. The FDA previously rebuffed regulatory submissions for the drug in dementia and Alzheimer’s disease.
The FDA’s rejection of Nuplazid cited clinical trial results in subgroups of patients. Acadia Pharmaceuticals said the FDA’s decision goes against all feedback the company previously received and amounts to an incorrect way of evaluating dementia patients.
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Nuplazid, which is FDA-approved for Parkinson's psychosis, failed to fully improve symptoms as an adjunctive treatment for schizophrenia.