Gocovri (amantadine) is the first medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of dyskinesia –involuntary, jerky movements – in Parkinson’s disease patients who are receiving levodopa-based therapy, with or without accompanying dopaminergic medications.

The drug, developed by Adamas Pharmaceuticals, is available as extended release capsules to be taken by mouth.

How Gocovri works

Parkinson’s disease leads to the malfunction or death of nerve cells responsible for producing a chemical called dopamine, which is essential to pass signals 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. Nevertheless, 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 patients with Parkinson’s disease is unknown. However, the drug has been shown to increase dopamine release and block dopamine re-uptake, thereby functioning as a mild dopamine agonist.

Gocovri in clinical trials

The FDA’s approval was based on data from three randomized and placebo-controlled trials, involving a total of 286 patients, which evaluated the safety and effectiveness of Gocovri in reducing involuntary muscle movements caused by levodopa. During the trials, Gocovri was taken at bedtime, which helped maintain its 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 that the drug significantly reduced dyskinesia compared to placebo (a 27 percent reduction), and increased levodopa’s “on time” (the time a patient goes without Parkinson’s symptoms after taking a medication).

A 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 for 24 weeks. 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), and maintained through to week 24. Gocovri also increased patients “on time” and reduced the “off time” period (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, intensity, and disability associated with dyskinesia at week 12, and reduced “off time”.

An open-label study (NCT02202551) to evaluate the long-term (105 weeks) safety and tolerability of Gocovri in Parkinson’s disease patients who have levodopa-induced dyskinesia is ongoing. 

Other details

The most common adverse reactions associated with the use of Gocovri were hallucinations, dizziness, dry mouth, constipation, falls, and low blood pressure when getting up from a sitting or lying position.

According to the company, the drug is expected to be available in January 2018 and a patient assistance program called “Gocovri Onboard” has been created to facilitate access to the drug via reimbursement support, prescription fulfillment, and financial assistance.

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