The Food and Drug Administration has decided not to approve an expanded use of the psychosis drug pimavanserin (Nuplazid) to treat patients with Alzheimer’s disease.
Nuplazid was approved in 2016 for treating hallucinations and delusions tied to Parkinson’s disease psychosis. The FDA in April rejected a subsequent attempt by its maker, Acadia Pharmaceuticals, to win broader approval for use in dementia patients, according to FiercePharma.
The company then requested approval solely for use in Alzheimer’s patients with dementia psychosis. (This subgroup accounts for about two-thirds of the people overall who have dementia psychosis.) But in late June, FDA advisors voted 9 to 3 that Acadia’ clinical trial data didn’t support that indication for these patients. The agency on Friday sent the company back to the drawing board, recommending an additional trial in this subgroup population, the pharmaceutical news outlet reported.
“We are disappointed with this outcome,” Acadia CEO Steve Davis said in a statement. “The treatment of Alzheimer’s disease psychosis continues to be an area of high unmet need, for which there is no approved therapy.”
The use of antipsychotics in dementia is dogged by concerns about the drugs’ risks. Some studies have tied the drugs to adverse health events such as falls and stroke, and a higher risk of death.