Acadia hits another Nuplazid roadblock as the FDA doles out CRL and recommends another trial
Despite winning an approval back in 2016, Acadia’s Nuplazid has not had the easiest of paths in its journey to expand into new areas. And late Thursday night, the company put out a press release saying it received more bad news from the FDA.
Regulators rejected Acadia’s application to expand Nuplazid coverage into Alzheimer’s-related psychosis, the biotech said, turning away its supplemental NDA with a CRL. The rejection letter indicated the FDA also recommended that Acadia conduct an additional trial in ADP, Acadia said.
According to Acadia, while the FDA stated its study did demonstrate a statistically significant treatment effect on its primary endpoint, limitations remain regarding its effectiveness.
The FDA added that although there was positive treatment effect of the drug on dementia-related psychosis in Acadia’s HARMONY study, it appeared to be driven primarily by patients with Parkinson’s disease dementia — a condition the FDA stated included Nuplazid’s approval for patients with Parkinson’s disease psychosis.
“We are disappointed with this outcome. The treatment of Alzheimer’s disease psychosis continues to be an area of high unmet need, for which there is no approved therapy. We want to express our gratitude to all of the patients, their families and investigators who have participated in our clinical trials,” Acadia CEO Steve Davis said in a statement.
The company did not respond to inquiries from Endpoints News. Acadia shares $ACAD are down 35% since January but remained flat in Friday morning trading.
Thursday’s news is just the latest in a string of issues that Nuplazid has faced. In 2018, the drug first came under fire after a report questioned its safety of the drug, but the FDA eventually gave an all-clear for its safety.
Amidst the push to have the drug treat dementia-related psychosis and with the FDA being attentive after the Aduhelm approval, the drug has not been winning favor with the FDA.
After a CRL in 2021, due to a “lack of substantial evidence of effectiveness” in a Phase III trial, the company returned to the FDA only to receive more bad news. In June, a panel of the FDA’s outside experts voted 9-3 stating that the drug did not appear to be effective at treating patients with Alzheimer’s-related psychosis.