UPDATED: A year after CRL, Acadia is going back to bat for Nuplazid at the FDA
A potential blockbuster drug for Acadia Pharmaceuticals is facing a new round of FDA scrutiny in June.
The FDA is holding a public advisory committee meeting on June 17 to discuss a supplemental new drug application for Nuplazid to treat hallucinations and delusions associated with Alzheimer’s disease psychosis.
While Nuplazid is already approved for patients with Parkinson’s disease psychosis, Acadia faced some hurdles when it came to an approval in patients with dementia-related psychosis, including a CRL back in 2021.
Nuplazid was hit with a CRL last April due to a “lack of substantial evidence of effectiveness” in a Phase III trial, according to the company. Regulators flagged a “lack of statistical significance in some of the subgroups of dementia,” as well as insufficient numbers of patients with certain less common dementia subtypes.
While no safety issues were raised, the initial CRL considered a supportive Phase II Alzheimer’s disease psychosis study not adequate or well-controlled. The study was cited as being a single-center study with no type I error control of secondary endpoints in which certain protocol deviations occurred. However, the company decided to soldier on, and in March Acadia resubmitted an NDA for Nuplazid.
As of now, there is no indication of any new data for the drug, or that any of the concerns FDA’s concerns have been addressed.
“We appreciate our ongoing engagement with the FDA and look forward to a productive discussion on the clinical evidence supporting the positive benefit-risk profile for pimavanserin as a treatment for ADP at the upcoming Advisory Committee meeting,” said Acadia CEO Steve Davis in a statement. “The hallucinations and delusions that Alzheimer’s patients endure represent one of the most significant burdens in this community, and one of the leading reasons for long-term care placement. There are no FDA-approved treatments for this critical public health need. Off-label use of multi-receptor acting antipsychotics with marginal efficacy and significant safety concerns can lead to poor patient outcomes, including worsening of cognition and motor function.”
According to the Alzheimer’s Association, approximately 6 million people in the United States are living with Alzheimer’s disease and approximately 30% of patients with the disease experience psychosis, commonly consisting of hallucinations and delusions. A treatment, if approved, could net Acadia a serious amount of money.
However, the Alzheimer’s treatment will likely be put through the wringer at the FDA on the heels of Biogen’s controversial Aduhelm approval.
This story has been updated to include comment from Acadia.