Acadia gets FDA OK for new formulation of Parkinson’s med

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced Food and Drug Administration (FDA) approval of a new capsule dose formulation and a new tablet strength of NUPLAZID (pimavanserin) to help in the treatment of patients living with hallucinations and delusions associated with Parkinson’s disease psychosis.

The FDA approval of a 34 mg NUPLAZID capsule formulation will provide patients with the recommended 34 mg once daily dose in a single, small capsule, reducing patient pill burden versus the current administration of two 17 mg tablets. In addition, the FDA approval of a 10 mg tablet provides an optimized lower dosage strength in those patients who are concomitantly receiving strong cytochrome 3A4 inhibitors which can inhibit the metabolism of NUPLAZID.

“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 for the 34 mg once daily NUPLAZID dosing regimen, while also reducing the overall pill burden for my Parkinson’s disease patients who often also take multiple other medications concomitantly.”

The NUPLAZID 34 mg capsules and 10 mg tablets will be available by mid-August.

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