The US FDA has approved Nuplazid (pimavanserin), the first drug to treat the hallucinations and delusions associated with Parkinson’s disease (PD) psychosis.
The drug, which was granted breakthrough therapy designation and priority review, may help relieve symptoms experienced by the approximately 50% of Parkinson’s patients with PD psychosis.
Previously, the FDA’s Psychopharmacologic Drugs Advisory Committee voted 12 to 2 that the benefits of Acadia Pharmaceuticals’ pimavanserin outweigh the risks in treatment of PD psychosis. Concerns about off-label usage have been raised, however the lack of treatment alternatives favored an endorsement.
There are currently no other approved treatments for the condition. The use of typical antipsychotics often results in adverse drug reactions with dopamine. Nuplazid, which is a once-daily selective serotonin inverse agonist that targets 5-HT2A receptors, has no known adverse impact on motor symptoms.
“Today’s approval of Nuplazid represents a major paradigm shift in the treatment of Parkinson’s disease psychosis,” Michael S. Okun, MD, Medical Director of The National Parkinson Foundation, said in a statement. “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.”
Efficacy was demonstrated in a Phase 3 trial of 199 participants, in which Nuplazid met all primary and secondary endpoints with statistical significance.
Acadia plans to make the drug available to patients beginning in June 2016. The pharmaceutical company is also launching NuplazidConnect, which will provide financial and access assistance to patients, caregivers, and physicians.
For more information, visit nuplazid.com.
FDA approves first drug to treat hallucinations and delusions associated with Parkinson’s disease. FDA News Release. Published April 29, 2016. Accessed May 2, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm498442.htm