New Dosing Formulation and Strength for Pimavanserin Approved

Friday, June 29, 2018


The Food and Drug Administration (FDA) has approved a new capsule dose formulation and a new tablet strength of pimavanserin (Nuplazid; Acadia Pharmaceuticals, San Diego, CA). Both the new dose and the new formulation are expected to ease treatment for patients living with hallucinations and delusions associated with Parkinson’s disease psychosis.

Approval of a 34 mg capsule formulation of pimavanserin allows patients to take the recommended 34 mg dose once per day in a single, small capsule, which will reduce patient pill burden compared to the administration of 2 tablets of 17 mg each. Approval of a 10 mg tablet provides an optimized lower dosage for patients who take pimavanserin and strong cytochrome 3A4 inhibitors that can inhibit pimavanserin metabolism. Both the new formulation and new dose are expected to be available in mid-August, 2018.

“We are very pleased with the FDA approval of the Nuplazid 34 mg capsule and 10 mg tablet, underscoring ACADIA’s continued dedication to advancing safe and effective treatment options for patients living with hallucinations and delusions associated with Parkinson’s disease psychosis,” said Steve Davis, ACADIA’s President and Chief Executive Officer.

“NUPLAZID is a significant advance in our treatments for the hallucinations and delusions in Parkinson's disease,” said Dr. Joseph H. Friedman, Butler Hospital and Warren Alpert Medical School of Brown University. “The replacement of two 17 mg tablets with a single 34 mg capsule provides a simpler and more straightforward approach. . .”

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