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FDA Approves New Dosing Formulation for Nuplazid

Acadia Pharmaceuticals Inc. news release; 2018 Jun 29

Acadia Pharmaceuticals Inc. has announced the US Food and Drug Administration (FDA) has approved 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 disease psychosis. Acadia Pharmaceuticals Inc. is headquartered in San Diego, CA.

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 vs the current administration of 2 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.

Dosage/administration: The recommended dose is 34 mg taken orally once daily, without titration. It can be taken with or without food.

Adverse reactions: Most common adverse reactions (≥5% and twice the rate of placebo) are

peripheral edema and confusional state.

Citation:

Acadia Pharmaceuticals announces FDA approval of new dosing formulation and strength for Nuplazid (pimavanserin). [news release]. San Diego, CA: Acadia Pharmaceuticals Inc. June 29, 2018. https://www.businesswire.com/news/home/20180629005125/en/. Accessed July 10, 2018.

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