With the goal of treating dyskinesia in certain Parkinson’s disease patients, Adamas Pharmaceuticals of Emeryville, California recently obtained U.S. Food and Drug Administration approval for its Gocovri (amantadine) extended release capsules.
Defined as an irregularity in or impairment of voluntary movement, dyskinesia is seen commonly in individuals with Parkinson’s disease and can be identified by jerky, erratic or spasmodic appearance in physical motion.
Adamas Pharmaceuticals develops treatments for chronic neurologic disorders. The relative safety of Gocovri, a medicine taken once daily, was determined in two Phase 3 clinical trials resulting in successful approval; it is indicated for those patients receiving levodopa-based therapy.
"Today's approval is a tremendous milestone for Adamas and for the Parkinson's disease community," Adamas founder, Chairman and CEO Gregory Went said. "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.”
Dr. Rajesh Pahwa, a neurology professor at the Kansas Medical Center and director of the University of Kansas Health System’s Parkinson's Disease Center of Excellence, commended the designation.
"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,” Pahwa said, citing both symptoms as unmet needs.
All biological processes, including the body’s responses to disease and drug interventions, are governed by complex timing patterns, the company stated on its website.