29 April 2016 - The U.S. FDA today approved Nuplazid (pimavanserin tartrate), the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease.

Nuplazid was granted breakthrough therapy designation for the treatment of hallucinations and delusions associated with Parkinson’s disease. Breakthrough therapy designation is a program designed to expedite the development and review of drugs that are intended to treat a serious condition and where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint. The drug was also granted a priority review. The FDA’s priority review program provides for an expedited review of drugs that offer a significant improvement in the safety or effectiveness for the treatment, prevention, or diagnosis of a serious condition.

Nuplazid is marketed by Acadia Pharmaceuticals Inc. of San Diego, California.

For more details, go to: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm498442.htm