The U.S. Food and Drug Administration approved Gocovri (amantadine) in August 17. Adamas began making the extended release capsules available in the United States in October 2017.
It has now assembled a 59-person team to acquaint doctors and patients with it. It is calling the deployment of the team its U.S. launch of Gocovri.
Involuntary muscle movements, which disrupt daily activities, affect an estimated 90 percent of Parkinson’s patients.
Gocovri is the first and only treatment the FDA has approved for involuntary muscle movements, or dyskinesia, in Parkinson’s patients who are taking levodopa. The approval covers patients on levodopa by itself or a combination of levodopa and other dopamine-generating agents.
Dopamine is a chemical that is essential to transmitting brain signals to the muscles and controlling movement. Parkinson’s affects nerve cells responsible for producing dopamine. The loss of the neurotransmitter leads to a progressive deterioration in muscle coordination and movement.
One of the first lines of treatment for Parkinson’s is using levodopa to replace dopamine. But its long-term use can disrupt the balance of chemical messengers that control movement, causing dyskinesia.
“The launch of Gocovri, which was demonstrated in clinical studies to reduce both dyskinesia and OFF time, gives physicians a new tool for the treatment of Parkinson’s disease patients with dyskinesia,” Dr. Rajesh Pahwa, who directs the University of Kansas Medical Center’s Parkinson’s Disease Center, said in a press release.
Clinical trials have shown that Gocovri can increase the release of dopamine.
Gocovri offers doctors an alternative to managing dyskinesia that can avoid levodopa’s widespread side effects.
In a related development, Adamas has established a program to help patients obtain access to Gocovri. The Gocovri Onboard initiative includes prescription-filling and financial assistance. More information is available on the program’s website.