FDA approves first drug for Parkinson’s psychosis

The U.S. Food and Drug Administration (FDA) has now approved the first drug specifically for treating the psychotic events that accompany late-stage Parkinson’s disease.

The drug had been designated a breakthrough therapy and was granted FDA priority review status earlier this month. As anticipated, the drug sailed through the final approval stages.

Acadia Pharmaceuticals’ pimavanserin (also called Nuplazid) is the first antispychotic that doesn’t seem to interact with dopamine receptors, giving it the ability to control psychoses without impeding motor functions. No other drug had been effective at reducing the disturbing hallucinations and delusions associated with the pyschosis without also interfering with the brain signals that control smooth movements.

In clinical trials, the most common side effects reported by participants taking Nuplazid were: swelling, usually of the ankles, legs, and feet due to the accumulation of excessive fluid in the tissue (peripheral edema); nausea; and abnormal state of mind (confused state), noted the FDA in a press release.

About 40 percent of those with Parkinson’s disease will experience psychosis.

Topics: Alzheimer's/Dementia , Clinical