FDA First: Adamas Parkinson’s Drug Approved for Dyskinesia

The US Food and Drug Administration (FDA) has approved the first therapy for patients with Parkinson’s disease-associated dyskinesia. Adamas Pharmaceuticals’ drug Gocovri is indicated for patients who are already receiving levodopa-based therapy to lesson symptoms of the movement disorder.

“Gocovri’s approval is an important advancement for the treatment of Parkinson’s disease, as it is the first FDA-approved medicine for the treatment of dyskinesia in Parkinson’s disease patients,” said Dr. Rajesh Pahwa, Laverne & Joyce Rider Professor of Neurology at the Kansas Medical Center and Director, Parkinson’s Disease Center of Excellence at the University of Kansas Health System. “Notably, Gocovri is the first Parkinson’s disease medicine proven in controlled trials to reduce both dyskinesia and OFF time in Parkinson’s disease patients receiving levodopa. Treatment of dyskinesia and OFF time continues to be an unmet need in the medical management of Parkinson’s disease and the approval of Gocovri is a major step in that direction.”

While levodopa can be an effective treatment for Parkinson’s by replacing the lost dopamine in the brain, it is also the primary cause of involuntary movements characteristic of dyskinesia. Gocovri is a once-daily, extended-release medication containing high dose amantadine.

“Dyskinesia can significantly compromise quality of life for people with Parkinson’s disease,” said Dr. Todd Sherer, Chief Executive Officer of The Michael J. Fox Foundation for Parkinson’s Research. “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.”

Data from two Phase III clinical trials was used to support Gocovri’s approval, based on its safety and efficacy profile. Patients treated with Gocovri showed a statistically significant reduction in dyskinesia of 37 percent for the first trial, and 46 percent for the second.

“Today’s approval is a tremendous milestone for Adamas and for the Parkinson’s disease community,” said Dr. Gregory T. Went, Founder, Chairman and Chief Executive Officer of Adamas Pharmaceuticals, Inc. “Gocovri has the potential to help people with Parkinson’s disease suffering from dyskinesia by finally providing physicians with an effective tool to address this long-standing unmet medical need.”

Nearly one million people in the US are affected by Parkinson’s disease. According to Adamas, almost 90 percent of all Parkinson’s patients treated with levodopa will eventually experience the involuntary movements characteristic of dyskinesia, highlighting a need to manage this side effect.