An advisory committee for the U.S. Food and Drug Administration (FDA) has given its support to a new drug treatment for Parkinson’s disease psychosis (PDP), bringing the treatment one step closer to possible approval. Acadia Pharmaceuticals’ experimental drug, pimavanserin (also called Nuplazid), is the first antispychotic that doesn’t seem to interact with dopamine receptors.
The FDA’s Psychopharmacologic Drugs Advisory Committee reviewed the data this week and voted 12-2 that the benefits seem to outweigh the risks, giving the drug a green light to move on to the next steps in the research and approval processes. The FDA also voted to give the drug Priority Review status, a level that will fast-track the drug through the new-drug approval process.
Currently, no drug has been approved by the FDA specifically to treat PDP. Drugs used to decrease psychosis often have the side effect of decreasing motor functions as well. If the new drug succeeds in lessening psychosis without affecting other functions, it would be the first of its kind discovered.
“PDP has been associated with nursing home placement, which itself has been associated with increased morbidity and mortality for these patients; therefore, a drug to prevent psychosis in this population without worsening motor function would, indeed, represent an important treatment advance,” the FDA Advisory Panel report states.
About 40 percent of those with Parkinson’s disease will experience psychosis.
Understanding Parkinson's disease psychosis