Acadia Pharmaceuticals has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) on its supplemental New Drug Application (sNDA) for NUPLAZID (pimavanserin).
This drug is intended for the treatment of hallucinations and delusions related with Alzheimer’s disease psychosis (ADP).
The CRL showed that the FDA has finished review of the application, and determined that it could not approve the sNDA in its current form, and recommended the company to undertake an additional trial in ADP.
Although the FDA stated that Study 019 showed a statistically important treatment impact on its primary endpoint, it concluded that there are limitations in the interpretability of the study results.
The regulatory body further stated that the positive treatment impact of pimavanserin on dementia-related psychosis in Study 045 (HARMONY) seems to be driven by the robustly positive results in the Parkinson’s disease dementia subgroup, a condition they stated is subsumed within the presently approved NUPLAZID Parkinson’s disease psychosis (PDP) indication.
Up to 50% of PDP patients suffer from dementia.
Acadia Pharmaceuticals CEO Steve Davis said: “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.
“We want to express our gratitude to all of the patients, their families and investigators who have participated in our clinical trials.”
In 2016, the US FDA approved NUPLAZID, which is the first and only treatment for hallucinations and delusions associated with PDP.
As per the Alzheimer’s Association, around six million people in the US are living with Alzheimer’s disease (AD).
Around 30% of patients with AD experience psychosis, commonly consisting of hallucinations and delusions.