Pimavanserin Label Updated to include Sprinkling Administration Option

Ponni Subbiah, MD, MPH

Recently, Acadia Pharmaceuticals announced that the FDA has approved its prior approval supplement application for updating the prescribing information for its agent pimavanserin (Nuplazid), which is currently indicated for the treatment of hallucinations and delusions associated with Parkinson disease psychosis.¹

All told, the labeling update provides instructions for the sprinkling of the capsule contents onto both food and liquids for dosing and administration. The capsules, which can be swallowed whole, can be emptied over 15 mL of applesauce, yogurt, pudding, or a liquid nutritional supplement for patients with Parkinson disease who face difficulty in swallowing—a challenge that occurs for this population at a rate that is 3 times greater than in healthy elderly people.²

Acadia Pharmaceuticals noted that the drug/food mixture should be consumed immediately without chewing and not stored for future use.

“People living with Parkinson's, particularly those who are elderly, often experience difficulty swallowing as muscle control declines. With this in mind, Acadia obtained FDA approval for an additional method of administration for those prescribed Nuplazid for hallucinations and delusions associated with Parkinson's disease,” Ponni Subbiah, MD, MPH, senior vice president, global head of Medical Affairs, and chief medical officer, Acadia Pharmaceuticals, told NeurologyLive.

Subbiah added that this new delivery option offers “a proven palatable and swallowable alternative” for patients, their caregivers, and the health care professionals treating them, as well as those in long-term care facilities. “We're very pleased to continue to provide new options to patients and their providers,” she said.

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Pimavanserin, a selective serotonin inverse agonist and antagonist preferentially targeting 5HT2A receptors, was approved for the treatment of hallucinations and delusions associated with Parkinson disease psychosis by the FDA in April 2016. It was later granted breakthrough therapy designation for the treatment of hallucinations and delusions associated with DRP in October 2017.

This new label amendment comes just a few months after Acadia’s supplemental new drug application (sNDA) for the agent in the treatment hallucinations and delusions associated with dementia-related psychosis, which was filed in July 2020. The FDA has set a prescription drug user fee act (PDUFA) date of April 3, 2021, for that decision.³

The sNDA is supported by the results of the phase 3 HARMONY study (NCT03325556), in which pimavanserin met the primary end point, demonstrating a significant reduction in the risk of relapse of psychosis by 2.8-fold compared to placebo (hazard ratio [HR], 0.353; one-sided P = .0023). Data from the phase 2 (-019) study in patients with Alzheimer disease (AD) psychosis and the phase 3 (-20) study in patients with Parkinson disease (PD) psychosis, both of which also met their primary end points, also attributed to the sNDA.

Steve Davis, chief executive officer, Acadia, said at the time that “if approved, Nuplazid would be the first therapy indicated for the treatment of hallucinations and delusions associational with dementia-related psychosis. We look forward to potentially bringing this important treatment advancement to patients, caregivers and physicians.”

REFERENCES
1. Pimavanserin. FDA Label Prescribing information. Acadia Pharmaceuticals; 2020. Accessed December 10, 2020. accessdata.fda.gov/drugsatfda_docs/label/2016/207318lbl.pdf
2. Kalf JG, de Swart BJ, Bloem BR, et al. Prevalence of oropharyngeal dysphagia in Parkinson's disease: a meta-analysis. Parkinsonism & related disorders. 2012;18(4):311–315. doi: 10.1016/j.parkreldis.2011.11.006
3. Acadia Pharmaceuticals announces US FDA accepted for filing the supplemental new drug application for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis. News release. Acadia Pharmaceuticals. July 20, 2020. Accessed December 10, 2020. ir.acadia-pharm.com/news-releases/news-release-details/acadia-pharmaceuticals-announces-us-fda-accepted-filing