The US Food and Drug Administration (FDA) has approved Adamas Pharmaceuticals’ Gocovri for a new indication in patients with Parkinson’s disease experiencing OFF episodes.
The FDA has approved Gocovri (amantadine) as an adjunctive treatment to levodopa/carbidopa, a commonly-used treatment for the main symptoms of Parkinson’s disease.
When Parkinson’s progresses, individuals receiving levodopa-based therapy often experience the return of symptoms including stiffness, rigidity and tremors – referred to as OFF episodes between medication doses.
Although the primary treatment for Parkinson’s is levodopa, over time treatment with this drug can cause involuntary and uncontrolled movements referred to as dyskinesia.
In addition to this new indication approval for use in treating OFF episodes, Gocovri is approved to treat dyskinesia in Parkinson’s patients receiving levodopa/carbidopa therapy.
In two phase 3 clinical studies, Gocovri treatment was shown to significantly reduce both OFF time and dyskinesia.
Gocovri treatment also resulted in a clinically meaningful increase in good ON time – referring to when levodopa is working well and symptoms are controlled.
In addition, Adamas’ drug demonstrated sustained efficacy for at least two years in the phase 3 EASE LID-2 trial.
“The approval of a second indication for Gocovri is a major milestone for patients with Parkinson’s who experience motor complications in their daily lives,” said Neil McFarlane, chief executive officer of Adamas.
“Gocovri is now the first and only medication approved to treat both OFF and dyskinesia motor complications in Parkinson’s disease,” he added.
“We are delighted in the FDA’s responsiveness to our application to include the clinically meaningful reduction in OFF episodes in the indication statement which provides patients and physicians with accurate and complete information to make appropriate treatment decisions,” commented Adrian Quartel, chief medical officer.
“The extensive clinical trial evidence for Gocovri supports its unique ability to reduce OFF episodes and dyskinesia in people with Parkinson’s disease who are on levodopa/carbidopa therapy.
“Many PD medications necessitate a trade-off between reducing OFF time and exacerbating levodopa-induced dyskinesia. Gocovri is the first medication approved to reduce both,” Quartel added.