Adamas Pharmaceuticals yesterday announced U.S. Food and Drug Administration (FDA) approval of an extended-release formulation of amantadine (GOCOVRI) to treat dyskinesia in Parkinson’s disease (PD). This is the first drug indicated specifically for dyskinesia — uncontrolled, involuntary movements that can develop with long-term levodopa use.
Extended-release amantadine is intended to be taken once daily at bedtime. In this way it can control dyskinesia during the day, when it typically is most prevalent. The new therapy’s approval is based on data from three placebo-controlled trials that demonstrated safety and efficacy. In addition to easing dyskinesia, the drug also may lessen total daily “off” time, when Parkinson’s symptoms return because medication is not working optimally.
The Michael J. Fox Foundation (MJFF) helped move this drug to market by supporting the creation and authentication of the Unified Dyskinesia Rating Scale, a tool that was used to measure the drug’s impact in trials.
While levodopa-induced dyskinesia (LID) can occur shortly after levodopa initiation in some patients, for approximately 90 percent, it will eventually develop within 10 years after levodopa use.
“Dyskinesia can significantly compromise quality of life for people with Parkinson’s,” says Todd Sherer, MJFF CEO. “We are pleased that patients have another option to manage this aspect of the disease and glad the Unified Dyskinesia Rating Scale — a tool our support helped develop and validate — could show clinical efficacy of GOCOVRI for the treatment of dyskinesia.”
Extended-release amantadine is a reformulation of a currently available generic immediate-release version, which is approved to treat Parkinson’s symptoms.