A drug made by California-based biopharmaceutical company Acadia Pharmaceuticals, has become the first US Food and Drug Administration (FDA) approved treatment for psychosis linked to Parkinson’s disease. The regulator is requiring that Acadia include black box warning on the product, due to its association with an increased risk of death in older patients.
According to the National Institutes of Health (NIH), approximately 50,000 Americans receive a Parkinson’s diagnosis each year, and around one million people in the US suffer from the disease. The drug could address an unmet medical need by providing patients with Parkinson’s disease psychosis, with treatment options.
The drug – named Nuplazid – will likely carry a price tag of around $13,500 for a year of treatment. According to Leerink analyst Paul Matteis, the drug could reach sales of $1 billion in 2021.
“Hallucinations and delusions can be profoundly disturbing and disabling,” said Dr. Mitchell Mathis, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Nuplazid represents an important treatment for people with Parkinson’s disease who experience these symptoms.”
As other antipsychotics on the market also carry similar black box warnings, the FDA stipulation is not expected to affect sales of Nuplazid. Until now, Parkinson’s disease psychosis was treated with off-label antipsychotics, including quetiapine, clozapine, risperidone and olanzapine.
These drugs target the overproduction of the neurotransmitter dopamine, but are generally less effective and could cause side effects such as anxiety, depression and agitation. Nuplazid does not affect dopamine production, but instead targets a receptor – known as 5HT2A – which is associated with neuropsychiatric disturbances.
Almost 40 percent of Parkinson’s patients experience hallucination and delusions associated with psychosis. Although the new treatment could be one of the most expensive antipsychotic drugs available, Matteis said he believes the drug will likely be covered by private and government insurance companies.
“Through its novel and selective mechanism of action, Nuplazid is a breakthrough treatment that works in a whole new way – treating hallucinations and delusions without blocking dopamine receptors and, therefore, not impairing motor function in Parkinson’s psychosis patients,” said Michael Okun, medical director at the National Parkinson Foundation. According to Steve Davis, CEO of Acadia, Nuplazid represents a “major medical advancement for patients with Parkinson’s disease psychosis.”