www.fdanews.com/articles/176511-fda-gives-thumbs-up-to-first-dementia-related-psychosis-drug
FDA Gives Thumbs Up to First Dementia-Related Psychosis Drug
May 6, 2016
The FDA has approved Acadia Pharmaceuticals’ Nuplazid to treat Parkinson’s disease in patients suffering from psychosis-related hallucinations and delusions.
The tablet, which is the first drug to receive approval for this indication, was endorsed by an FDA panel on April 13. The panel’s recommendation was based solely on a six-week Phase 3 trial, an anomaly given the agency’s expectation of two or more positive clinical trials for approval.
Nuplazid’s approval comes with a caveat: a boxed warning cautioning health care professionals about the increased risk of death linked with use of the drug in patients suffering from dementia-related psychosis.