Drug To Treat Psychosis Related To Parkinson's Disease Set To Be Approved By The FDA

FDA Food and Drug Administration Nuplazid Psychopharmacologic Drugs Advisory Committee Acadia Pharmaceuticals Inc. Parkinson's disease Psychosis

By Denise , Parent Herald Mar 29, 08:00 am

There have been so many attempts to find a cure for Parkinson's and for any disorder associated with the disease. The U.S. Food and Drug Administration staff members said that Acadia Pharmaceuticals' drug to manage psychosis associated with Parkinson's disease was found to be effective enough to be approved.

After the 3-phase clinical trial of patients with PDP, the company said that the drug met the essential endpoint of the study by showing a highly important reduction in psychosis as compared to the placebo drug that was given. Reuters reported that the Psychopharmacologic Drugs Advisory Committee will have a meeting on Tuesday, March 29.The agenda of the meeting is to discuss the specific risk-benefit profile of the new drug application.

NUPLAZID (pimavanserin) is a 17 mg immediate-release, film-coated oral tablets, submitted by Acadia Pharmaceuticals Inc. for approval for the proposed treatment of psychosis associated with Parkinson's disease, the FDA said.

According to MedPage Today, Nuplazid (pimavanserin) is a new chemical compound and selective serotonin inverse agonist (SSIA) that targets 5-HT2A receptors would potentially be the first drug to be approved in the U.S for Parkinson's disease psychosis (PDP). "Nuplazid also met the key secondary endpoint for motoric tolerability. These results were further supported by highly significant improvements in all secondary efficacy measures and by statistically significant benefits in exploratory efficacy measures of nighttime sleep, daytime wakefulness, and caregiver burden," they note. "Consistent with previous studies, Nuplazid was safe and well tolerated in this phase III trial."

After the approval, it will only be a matter of time before psychosis related to Parkinson's disease can be cured. There are so many people who are already waiting for this drug to be available for public use. It will benefit not only the patient but also the family of the patient who also undergoes the same experience.