The U.S. Food and Drug Administration (FDA) approved the first drug for the treatment of Parkinson's-related psychosis. The newly approved Nuplazid (pimavanserin) tablets are designed to treat psychosis-related delusions and hallucinations among some patients with Parkinson's disease.
California-based Acadia Pharmaceuticals Inc. markets Nuplazid. A 199-participant, six-week clinical trial proved the drug's effectiveness.
Against a placebo drug, Nuplazid was able to reduce the severity or frequency, or both, of the episodes wherein the Parkinson's disease patient suffers from delusions and hallucinations. Notably, the drug does not worsen the disease's primary motor symptoms.
"Hallucinations and delusions can be profoundly disturbing and disabling. Nuplazid represents an important treatment for people with Parkinson's disease who experience these symptoms," said Mitchell Mathis, M.D., Division of Psychiatry Products director in FDA's Center for Drug Evaluation and Research.
During the trials, researchers observed the following side effects: nausea, confused state, and swelling of the feet, legs and ankles because of the excessive fluid accumulation in the tissue.
However, as with other atypical antipsychotic medications, Nuplazid comes with a "Boxed Warning" that alerts doctors and healthcare professionals about the increased drug use-related death risk among people with dementia-associated psychosis.
The price estimate for Nuplazid is $13,500 per patient annually. According to Leerink analyst Paul Matteis, the new drug could rake in approximately $1 billion in 2021 for sales. Nuplazid might become one of the antipsychotic drugs in the market with highest price tags.
"Insurers are less likely to ask patients to try cheaper off-label alternatives given their safety risks," added Matteis prior to the FDA's approval announcement.
According to the Parkinson's Disease Foundation, about 60,000 people are diagnosed with Parkinson's disease year after year in the United States. The foundation highlighted that this estimated figure does not cover thousands of undetected cases.
Around the world, there are about 7 to 10 million people who are suffering from Parkinson's. The risk of developing the disease increases with age, however, about 4 percent of the documented cases cover patients whose diagnoses were given before they turned 50.
The foundation added that approximately $25 billion is spent annually in the United States for the direct and indirect expenses associated with Parkinson's. This includes the treatments, income loss due to inability to work as well as payments on social security.