- Wikimedia Commons/MethoxyRoxy
A new drug that aims to treat a serious symptom of Parkinson’s disease just got approved by the Food and Drug Administration.
The drug, called Nuplazid, was developed by Acadia Pharmaceuticals. It is designed to treat psychosis, a symptom of Parkinson’s that can involve hallucinations and delusions, and it’s the first of its kind to ever get approved by the FDA.
Acadia’s stock was up 2% in early trading Monday. It’s up about 40% since March 28, the day before an FDA committee recommended its approval.
Parkinson’s disease is a neurodegenerative disorder characterized by motor symptoms such as shaking in the hands and legs as well as stiffness and impaired balance.
But as many as half of those with Parkinson’s are estimated to experience psychosis symptoms as well.
In the advisory committee meeting, the committee focused on data from a late-stage, six-week clinical trial of Nuplazid in 199 patients that suggested that the drug may benefit those with Parkinson’s disease psychosis, or PDP. Of the 199, about half were given Nuplazid in addition to any other Parkinson’s treatment they were already using, while the rest were given a placebo. None of the participants were allowed to take any other form of antipsychotic.
“Nuplazid was shown to be superior to placebo in decreasing the frequency and/or severity of hallucinations and delusions without worsening the primary motor symptoms of Parkinson’s disease,” the FDA said Friday in a release after its approval of the drug.
Before now, there were no approved treatments specifically for PDP, and clinical trials looking at the use of traditional antipsychotics to treat PDP suggest that they’re not particularly effective. Analysts estimate at least a $1 billion market for the drug.