Gocovri (amantadine) is a medication developed by Adamas Pharmaceuticals and approved by the U.S. Food and Drug Administration (FDA) for the treatment of dyskinesia, which are the involuntary, jerky movements in Parkinson’s disease patients who are receiving levodopa-based therapy.
How Gocovri works
Parkinson’s disease leads to the malfunction or death of nerve cells responsible for producing a chemical messenger called dopamine, which is essential to carry signals between nerve cells and from the brain to the muscles to control their movement. The loss of dopamine results in progressive loss of muscle coordination and movement.
The first line of treatment for Parkinson’s disease is the replacement of the dopamine that is lost using levodopa therapy. However, prolonged use of levodopa disrupts the balance of chemical messengers controlling motor function, leading to dyskinesia.
The exact mechanism by which Gocovri exerts its activity in the treatment of dyskinesia in Parkinson’s disease patients is unknown. However, the therapy has been shown to increase dopamine release and block dopamine re-uptake, thereby increasing dopamine levels in the brain.
Gocovri in clinical trials
The FDA’s approval of Gocovri to treat dyskinesia was based on data from three randomized placebo-controlled clinical trials involving a total of 286 patients. These trials evaluated the safety and effectiveness of Gocovri in reducing involuntary muscle movements caused by levodopa. During the trials, patients took Gocovri at bedtime, which helped maintain dopamine levels during the morning and waking hours, when dyskinesia usually occurs.
A Phase 2/3 study (NCT01397422) called EASED was designed to evaluate the tolerability and effectiveness of three doses of Gocovri compared to placebo in 83 Parkinson’s disease patients with levodopa-induced dyskinesia. The results of the trial showed the therapy significantly reduced dyskinesia compared to placebo by 27 percent, and increased levodopa’s “on time” (the time a patient goes without Parkinson’s symptoms after taking medication).
A 24-week Phase 3 trial (NCT02136914) called EASE LID assessed the safety and effectiveness of 340 mg of Gocovri once daily taken at bedtime in Parkinson’s disease patients with levodopa-induced dyskinesia. Results published in August 2017 showed that the medication significantly improved levodopa-induced dyskinesia at 12 weeks (37 percent decrease compared to 12 percent with placebo). This was maintained through week 24. Gocovri also increased patients “on time” and delayed off episodes (when the symptoms return) by almost one hour compared to placebo.
The results of another Phase 3 study (NCT02274766) called EASE LID 3 also showed that Gocovri decreased the duration and intensity of dyskinesia as well as disability associated with it at week 12. Gocovri also reduced off episodes in this trial.
The results of an open-label study (NCT02202551) to evaluate the long-term (105 weeks) safety and tolerability of Gocovri in Parkinson’s disease patients who had levodopa-induced dyskinesia were published in Movement Disorders Clinical Practices. The authors indicated that the data suggests that Gocovri provides an incremental reduction in MDS-UDPRS Part IV score (a Parkinson’s disease rating scale used to evaluate clinical trial results) in patients without exacerbating adverse side effects.
The most common adverse side effects associated with using Gocovri were hallucinations, dizziness, dry mouth, constipation, falls, and low blood pressure when getting up from a sitting or lying position.
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