FDA Approves ACADIA Pharmaceuticals’ NUPLAZID™ (pimavanserin)
The First Drug Approved for the Treatment of Hallucinations and Delusions Associated with Parkinson’s Disease Psychosis
U.S. Commercial Launch Planned for June 2016
The American Parkinson Disease Association is pleased to share the news that ACADIA Pharmaceuticals Inc., a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system (CNS) disorders, announced on April 29 that the U.S. Food and Drug Administration (FDA) has approved NUPLAZID (pimavanserin) for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. In 2014, the FDA designated NUPLAZID as a Breakthrough Therapy for this condition.
This news is groundbreaking for people with Parkinson’s disease who experience symptoms of psychosis. According to Marie Saint-Hilaire, MD, FRCP, Associate Professor of Neurology at Boston University School of Medicine and member of the APDA Scientific Advisory Board, “This is very important because it is the first medication approved for hallucinations in Parkinson’s which is a troublesome problem for both the person experiencing symptoms and their family members.”
NUPLAZID is the first and only medicine to be approved by the FDA for this indication. NUPLAZID is also the only drug approved by the FDA that preferentially targets 5-HT2A receptors. These receptors are thought to play an important role in Parkinson’s disease psychosis. The unique pharmacology of NUPLAZID establishes a new class of drug – selective serotonin inverse agonists (SSIA) – by not only preferentially targeting 5-HT2A receptors but also avoiding activity at dopamine and other receptors commonly targeted by antipsychotics. Typical Parkinson’s disease therapy consists of drugs that stimulate dopamine to treat patients’ motor symptoms such as tremor, muscle rigidity and difficulty with walking. NUPLAZID does not interfere with patients’ dopaminergic therapy and therefore does not impair their motor function.
Today, more than one million people in the United States and from four to six million people worldwide suffer from Parkinson’s disease. It is estimated that 40 percent of these patients have Parkinson’s disease psychosis, which is characterized by hallucinations and delusions, and is a major reason for nursing home placement among people with Parkinson’s.
“The approval of NUPLAZID is major medical advancement that will truly improve the quality of life for people with Parkinson’s disease psychosis. This is a difficult subject to address. We are hopeful that this news will open the dialogue and ultimately provide much needed treatment for those coping each day with hallucinations and delusions,” said Leslie A. Chambers, APDA President & CEO.
If you are a person with Parkinson’s or a family member with questions please contact APDA at 800-223-2732.
To read the full press release from ACADIA please click here