FDA Approves Nuplazid for Capsule Sprinkling

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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The U.S. Food and Drug Administration (FDA) has approved an update to the prescribing information for Nuplazid (pimavanserin) that will allow the medication to be taken more easily by Parkinson’s patients who have difficulty swallowing.

Nuplazid, by Acadia Pharmaceutical, is an oral medication that was approved by the FDA in 2016 for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. Under the prior approval, the once-a-day medication was available as a higher-dose capsule or a lower-dose tablet.

However, many people with Parkinson’s have difficulty swallowing, which can make it hard to take a medication in those forms.

According to an email from Acadia, the new labeling update provides instructions for sprinkling the contents of Nuplazid capsules on food for dosing and administration. Instead of swallowing capsules whole, the capsule can be opened, and its contents sprinkled over a tablespoon of easily-swallowed food, like applesauce, yogurt, pudding, or a liquid nutritional supplement.

The medication/food mix should be swallowed immediately, without chewing, and the mixture shouldn’t be stored. According to Acadia, this alternative method of administration is easier for certain Parkinson’s patients and caregivers, particularly in settings like long-term care facilities.

Nuplazid is the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis. According to Acadia, about half of the people with Parkinson’s will experience hallucinations (seeing, hearing, or feeling things that do not exist) or delusions (illogical or irrational views that are not based on reality) at some point in the course of their disease. 

The medication works by blocking the activity of proteins called serotonin 5-HT2A receptors, which play an important role in psychosis, schizophrenia, depression, and other neuropsychiatric disorders. The FDA’s original approval of Nuplazid was based on clinical trial data showing Nuplazid’s use lessened symptoms of Parkinson’s-related psychosis, and that the therapy was safe and well-tolerated.

The FDA is currently reviewing an application from Acadia asking that Nuplazid (pimavanserin) also be approved to treat hallucinations and delusions associated with various forms of dementia-related psychosis. The FDA’s decision on that application is expected by April 3, 2021.