Gocovri FDA Approval History

Last updated by Judith Stewart, BPharm on Feb 4, 2021.

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: Parkinson's Disease

Gocovri (amantadine hydrochloride) is a chrono-synchronous amantadine therapy indicated:

• for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
• as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes.

Development timeline for Gocovri

Date	Article
Feb  1, 2021	Approval Adamas Announces FDA Approval for Second Indication for Gocovri as an Adjunctive Treatment to levodopa/carbidopa in Parkinson’s Disease Patients Experiencing OFF Episodes
Aug 24, 2017	Approval FDA Approves Gocovri (amantadine) for the Treatment of Dyskinesia in Parkinson's Disease Patients
Jun 12, 2017	Adamas Announces Publication of ADS-5102 Phase 3 EASE LID Clinical Trial in JAMA Neurology
Jan  6, 2017	Adamas 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, 2016	Adamas Submits New Drug Application to U.S. FDA for ADS-5102 for the Treatment of Levodopa-induced Dyskinesia in Patients with Parkinson's Disease

Further information

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