The U.S. Food and Drug Administration (FDA) has accepted a request by Acadia Pharmaceuticals‘ that Nuplazid (pimavanserin) be approved for a new indication: the treatment of delusions and hallucinations associated with dementia-related psychosis.
No issues were found with the application, and the agency is not planning to request an advisory committee meeting — a process used to solicit scientific advice from independent evaluators.
“We are pleased that the FDA has accepted our sNDA for filing and we will be working closely with the FDA to facilitate completion of the review in a timely manner,” Steve Davis, CEO of Acadia, said in a press release.
An estimated 8 million people in the U.S. have dementia, and about 30% — 2.4 million people — experience dementia-related psychosis.
While half of these patients will be treated for psychosis, no medication is specifically indicated as a treatment for its related hallucinations and delusions.
“If approved, Nuplazid would be the first therapy indicated for the treatment of hallucinations and delusions associated with dementia-related psychosis,” said Davis. “We look forward to potentially bringing this important treatment advancement to patients, caregivers and physicians.”
Nuplazid is a selective serotonin inverse agonist (SSIA) that specifically binds to serotonin 5-HT2A receptors and blocks their activity. These receptors have been shown to be involved in psychosis, depression, and other neuropsychiatric disorders.
Nuplazid was approved in 2016, under FDA’s breakthrough therapy designation, to treat hallucinations and delusions associated with psychosis in people with Parkinson’s disease. The approval was based on data that showed the medicine could ease symptoms of psychosis in Parkinson’s patients, while showing only minimal signs of the debilitating effects associated with other anti-psychotic treatments.
Results from three clinical trials support the application, including the pivotal Phase 3 HARMONY trial (NCT03325556). In this study, 351 patients with dementia-related psychosis were given one of two daily doses of Nuplazid, 34 mg or 20 mg, or a placebo. All were followed for 26 weeks or until a psychosis relapse.
The study found that patients given Nuplazid, compared with those given a placebo, were 2.8 times less likely to experience a relapse of psychosis, a statistically significant reduction.
Nuplazid was well-tolerated, and was not associated with cognitive decline over the nine-month testing period.
HARMONY included people with Alzheimer’s- and Parkinson’s-related dementia, dementia with Lewy bodies, vascular dementia, and frontotemporal dementia.
Results from two other studies, a Phase 2 trial in patients with Alzheimer’s-related psychosis (NCT02035553) and a Phase 3 trial in Parkinson’s-related psychosis (NCT01174004), further demonstrated Nuplazid’s effectiveness.
Safety data from more than 1,500 people with a neurodegenerative disease who enrolled in completed and ongoing clinical studies were also included in the application.
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