FDA approves new formulation, dosage strength of Nuplazid for Parkinson’s psychosis

The FDA approved a new capsule dose formulation and tablet strength of Nuplazid to treat hallucinations and delusions associated with Parkinson’s disease psychosis, according to a press release.

The new 34-mg formulation of Nuplazid (pimavanserin, Acadia Pharmaceuticals Inc.) will now be available in a single, small capsule, rather than two 17-mg tablets, minimizing pill burden for patients, according to the release.

The FDA also approved a 10-mg tablet of pimavanserin that offers an optimized lower dose for patients who receive strong cytochrome 3A4 inhibitors, according to the release.

“Nuplazid is a significant advance in our treatments for the hallucinations and delusions in Parkinson’s disease,” Joseph H. Friedman, MD, from Butler Hospital and Warren Alpert Medical School of Brown University, said in the release. “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 34-mg capsules and 10-mg tablets of pimavanserin will be available by mid-August, according to the release.

Disclosure: Healio Internal Medicine could not confirm relevant financial disclosures at the time of publication.