ACADIA Pharmaceuticals Submits Supplemental New Drug Application to U.S. FDA for NUPLAZID® (pimavanserin) for the Treatment of Hallucinations and Delusions Associated with Dementia-Related Psychosis
The FDA previously granted Breakthrough Therapy Designation for pimavanserin for the treatment of hallucinations and delusions associated with DRP.
- The FDA previously granted Breakthrough Therapy Designation for pimavanserin for the treatment of hallucinations and delusions associated with DRP.
- NUPLAZID was approved in the U.S. in 2016 as the first and only treatment for hallucinations and delusions associated with Parkinsons disease psychosis.
- If approved by the FDA, NUPLAZID would be the first drug approved to treat the hallucinations and delusions associated with dementia-related psychosis and would be the second indication for NUPLAZID.
- NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinsons disease psychosis.