Shares of Acadia are up more than 12% in early trading after the FDA published briefing documents related to its supplemental NDA for antipsychotic therapeutic.
Shares of Acadia Pharmaceuticals are up more than 12% in early trading after the U.S. Food and Drug Administration published briefing documents related to the company’s supplemental New Drug Application for an antipsychotic therapeutic ahead of an advisory committee meeting on Friday.
Acadia is seeking approval for Nuplazid (pimavanserin), a selective serotonin inverse agonist and antagonist that preferentially targets 5-HT2A receptors, as a potential treatment for hallucinations and delusions associated with Alzheimer’s-related psychosis.
Nuplazid was the first drug approved for hallucinations and delusions associated with Parkinson’s disease psychosis. Currently, no treatment is approved for hallucinations and delusions associated with Alzheimer’s disease psychosis.
This is San Diego-based Acadia’s second time at bat for Nuplazid in this indication. Last year, the FDA issued a Complete Response Letter to the company, suggesting a lack of statistical significance in some of the dementia subgroups.
After Acadia included additional analyses from two previously conducted clinical studies, HARMONY and Study -019, the company resubmitted its sNDA. In its briefing documents, the FDA noted that these data points meet its requirements to consider Nuplazid for this indication.
The FDA did note some concerns with Study-019 related to what it called “protocol deviations.” The FDA said some participants in that study do not have “clear documentation that psychotic symptoms developed after AD (Alzheimer’s disease) diagnosis had been established or subjects who received exclusionary medications at the time of randomization.”
In its response, Acadia acknowledged some difficulties establishing the date of a diagnosis of Alzheimer’s disease in these patients. Acadia also noted some patients were excluded due to their psychosis being caused by another psychiatric condition, such as schizophrenia, or related to substance abuse. The company also repeated its per-protocol analysis to assess those protocol deviations, and the results favor Nuplazid.
“Based on this analysis and on the nature and the balanced distribution of the deviations, the agency anticipates that we will be able to rely upon the data from Study-019 for regulatory decision making,” the FDA said.
Additionally, the FDA noted that there were no key safety concerns regarding the use of Nuplazid for this indication. The findings from the sNDA development program were generally consistent with the known safety profile of pimavanserin (Nuplazid).
An estimated 6 million people in the United States live with Alzheimer’s disease. Of those, approximately 30% of patients experience psychosis, which typically consists of hallucinations and delusions. Serious consequences have been associated with psychosis in patients diagnosed with dementia, including an increased likelihood of being placed in a nursing home, worsening dementia issues and increased risk of morbidity and mortality.
Last month, when the advisory committee meeting was announced, Acadia Chief Executive Officer Steve Davis said hallucinations and delusions experienced by some Alzheimer’s patients represent “one of the most significant burdens in this community and one of the leading reasons for long-term care placement.” Because there are no approved medications for this indication, he said this is a 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,” he added.
The FDA’s Psychopharmacologic Drugs Advisory Committee will meet Friday to dissect the data around Nuplazid for this indication and will provide its recommendations regarding potential approval. The FDA is not bound to the decisions of an advisory committee but typically follows its advice.
