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FDA Approves Extended-Release Amantadine (Gocovri)

for treatment of Dyskinesia   

Friday, Aug 25, 2017

The Parkinson’s Foundation alerts the community that extended-release amantadine capsules (GOCOVRI™) have been approved by the US Food and Drug Administration (FDA) for the treatment of dyskinesia in people with Parkinson's disease receiving levodopa-based therapy. This new approval was announced by the manufacturer on August 24.

Below is a statement on this approval from Michael S. Okun, M.D., National Medical Director, Parkinson’s Foundation:

“Today, the US Food and Drug Administration (FDA) announced the approval of an extended-release amantadine capsule called GOCOVRI™. This drug will provide a practical once a day solution for dyskinesia management and reducing 'off' time. Patients who are currently well managed using multiple doses per day of generic amantadine for dyskinesia will not likely derive additional symptomatic benefits from switching to once a day dosing; however, patients experiencing side effects from amantadine may wish to discuss options with their neurologist.
"Both GOCOVRI and generic amantadine use is linked to a risk of side effects such as dizziness, hallucinations or blotching on the skin of the legs.  If you are considering starting this medicine or switching to this medicine we recommend consulting with your doctor.
"In an independent Parkinson’s Foundation study prior to this approval, we found that generic amantadine use improved dyskinesia in patients.  However, amantadine use does have a risk of side effects including insomnia and hallucinations. GOCORVI has been designed to limit the risk of these complications and it will not carry generic amantadine’s warning for insomnia.”

From Parkinson Disease Foundation, August 25, 2017

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