The U.S. Food and Drug Administration (FDA) found “deficiencies” that preclude discussing further steps in the approval process for Nuplazid (pimavanserin) as a possible treatment of dementia-related psychosis, according to a press release from Acadia Pharmaceuticals, Nuplazid’s maker.
Discussions on “labeling and post-marketing requirements/commitments” cannot take place before certain issues related to the therapy’s supplemental new drug application (sNDA) are resolved, the FDA notification stated.
The FDA’s notice to Acadia is not a final decision on the application, which is under review, but likely reflects a need for more information. The specific deficiencies noted by the agency were not detailed.
“[T]here has been no clarification by the FDA at this time. The Company plans to work with the FDA to learn the nature of the deficiencies and seek to resolve them,” Acadia said in its release.
With its sNDA, Acadia is asking that Nuplazid be approved to treat the delusions and hallucinations associated with dementia-related psychosis. The FDA approved the therapy for treating psychosis-associated hallucinations and delusions in people with Parkinson’s disease in 2016.
The agency agreed to consider Acadia’s request to expand the treatment’s use to cover dementia-related psychosis in July 2020, with a decision expected by April 3.
“If approved, Nuplazid would be the first therapy indicated for the treatment of hallucinations and delusions associated with dementia-related psychosis,” Steve Davis, CEO of Acadia, said at the time.
Classified as a selective serotonin inverse agonist, Nuplazid specifically blocks the activity of serotonin 5-HT2A receptors. Past research has linked these receptors to psychosis, depression, and other neuropsychiatric disorders.
Nuplazid was found to significantly lower the risk of a psychosis relapse — a worsening of hallucinations and delusions — in a wide range of people with dementia-related psychosis who participated in the Phase 3 HARMONY trial (NCT03325556). People taking Nuplazid in this trial were 2.8 times less likely to experience a psychosis relapse than those given a placebo.
HARMONY enrolled 392 patients with a mean age of 74.5. Of these, 76% were Alzheimer’s patients with related dementia, while about 15% had Parkinson’s-related dementia, Acadia reported in 2019.
The therapy was found to be well tolerated, and its use did not associate with the cognitive decline that accompanies the use of other antipsychotic medications throughout the trial’s nine months.
The most common side effects included headaches (9.5% with Nuplazid vs 4.5% with placebo) and urinary tract infections (6.7% vs 3.6%).
Two other clinical trials supported Nuplazid’s effectiveness. These were a Phase 2 trial (NCT02035553) in individuals with Alzheimer’s disease psychosis that reported short-term benefits, and a Phase 3 study (NCT01174004) in people with Parkinson’s disease psychosis. The latter study supported the application leading to Nuplazid’s current FDA approval.
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