Complete Response Letter from FDA for sNDA for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis.-Acadia Pharma

The CRL indicated that the FDA has completed review of the application, determining that it could not approve the sNDA in its present form, and recommended that Acadia conduct an additional trial in ADP. While the FDA stated that Study 019 demonstrated a statistically significant treatment effect on its primary endpoint, they concluded that there are limitations in the interpretability of the 019 results. The FDA also stated that the positive treatment effect of pimavanserin on dementia-related psychosis in Study 045 (HARMONY) appeared to be driven by the robustly positive results in the Parkinson’s disease dementia subgroup, a condition they stated is subsumed within the currently approved Nuplazid Parkinson’s disease psychosis (PDP) indication. Up to 50 percent of PDP patients have dementia.