FDA Approves Pimavanserin Administration by Opening Capsule and Sprinkling Onto Food or Into Liquid

The Food and Drug Administration (FDA) approved a supplement application to update the pimavanserin (Nuplazid; Acadia Pharmaceuticals, San Diego, CA) prescription information. This update provides instructions for sprinkling the contents of pimavanserin capsules on food and liquids for dosing and administration. Pimavanserin capsules can be swallowed or be opened and the entire contents of the capsule sprinkled over a tablespoon (15 mL) of soft food such as applesauce, yogurt, pudding, or liquid nutritional supplement. The pimavanserin mixture with the food should not be chewed and should be swallowed immediately.
 
This updated method of administration provides a much-needed option for people with Parkinson disease (PD) who may have difficulty swallowing. Studies show that patients with PD develop difficulty swallowing approximately 3 times more than healthy elderly people. This new sprinkle dosage and administration option provides a proven palatable and swallowable alternative to ease administration of pimavanserin for patients, caregivers, and clinicians as well as in and in certain settings like long-term care facilities.
 
Pimavanserin is the first and only FDA-approved treatment for hallucinations and delusions associated with PD psychosis. Around 50% of people living with PD may experience hallucinations or delusions during the course of their disease.

The most common adverse events (≥2% for pimavanserin and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusion (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).