The USFDA has approved Gocovri (amantadine) extended release capsules for treating dyskinesia in patients with Parkinson’s disease who are receiving levodopa-based therapy.
Parkinson’s disease is a neurodegenerative disorder due to a loss of dopaminergic neurons in the brain. It is a debilitating disorder in which brain cells progressively die causing patients to experience tremors, rigidity, extreme slowness of movement, impaired balance, and difficulties in swallowing and speaking.
A majority of patients diagnosed with Parkinson’s are treated with levodopa, whose use often leads to dyskinesia – involuntary movements that are non-rhythmic, purposeless and unpredictable.
The therapy, Gocovri (amantadine) by Adamas Pharmaceuticals, is an long-acting and extended-release capsule, indicated for those receiving levodopa-based therapy, with or without other dopaminergic medications. These are drugs, that, like levodopa, affect the activity of the neurotransmitter dopamine.
The drug’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 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.”The approval was based on data from 2 Phase 3 clinical trials showing the drug to significantly reduce Unified Dyskinesia Rating Scale (UDysRS) total scores (37% in the first trial and 46% in the second). Patient-reported diaries showed the drug allowed for an increase of 3.6 and 4.0 hours in daily functional time (defined as ‘on time’ without troublesome dyskinesia) compared to 0.8 and 2.1 hours in the placebo-treated patients in the 2 studies. Furthermore, Gocovri reduced ‘off time,’ or periods of the day when levodopa is not working well, by approximately 1 hour.
“Today’s approval is a tremendous milestone for Adamas and for the Parkinson’s disease community,” said Gregory T. Went, Ph.D., 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. We thank the physicians, clinical staff, patients and their families who participated in the clinical trials for making this advancement possible for the community.”
