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Gocovri Approval History

FDA Approved: Yes (First approved August 24, 2017)
Brand name: Gocovri
Generic name: amantadine hydrochloride
Dosage form: Extended-Release Capsules
Previous Name: ADS-5102
Company: Adamas Pharmaceuticals, Inc.
Treatment for: Levodopa-Induced Dyskinesia

Gocovri (amantadine hydrochloride) is a chrono-synchronous amantadine therapy for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease.

Development History and FDA Approval Process for Gocovri

DateArticle
Aug 24, 2017Approval FDA Approves Gocovri (amantadine) for the Treatment of Dyskinesia in Parkinson's Disease Patients
Jun 12, 2017Adamas Announces Publication of ADS-5102 Phase 3 EASE LID Clinical Trial in JAMA Neurology
Jan  6, 2017Adamas Announces U.S. FDA Acceptance of ADS-5102 New Drug Application for the Treatment of Levodopa-induced Dyskinesia in Patients with Parkinson's Disease
Oct 27, 2016Adamas Submits New Drug Application to U.S. FDA for ADS-5102 for the Treatment of Levodopa-induced Dyskinesia in Patients with Parkinson's Disease
Sep 20, 2016Adamas Announces Results of EASE LID 3, a Pivotal Trial of ADS-5102 for the Treatment of Levodopa-induced Dyskinesia (LID) in Parkinson's Disease Patients at the 4th World Parkinson Congress
Jun 11, 2015Adamas Begins Phase 2 Clinical Trial Assessing ADS-5102 for Treating Multiple Sclerosis Symptoms in Patients With Walking Impairment

Further information

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