Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for NUPLAZID(R) (pimavanserin) for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis (ADP).
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.(1)
"We are disappointed with this outcome. The treatment of Alzheimer's disease psychosis continues to be an area of high unmet need, for which there is no approved therapy," said Steve Davis, Chief Executive Officer. "We want to express our gratitude to all of the patients, their families and investigators who have participated in our clinical trials."
NUPLAZID was approved in the U.S. in 2016 and is the first and only treatment for hallucinations and delusions associated with PDP.
