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# FDA Accepts Adamas Pharma NDA for Parkinson’s
- URL: https://www.fdaweb.com/fda-accepts-adamas-pharma-nda-for-parkinsons/
- Published: 2017-01-09T12:00:00.000Z
- Updated: 2026-09-14T21:58:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137671

FDA has accepted for review an Adamas Pharmaceuticals NDA for ADS-5102 (amantadine hydrochloride) extended-release capsules for treating levodopa-induced dyskinesia in patients with Parkinson’s disease. The submission has been given a user fee review target date of 8/24\. “Over time, 90% of patients on levodopa therapy suffer from levodopa-induced dyskinesia,” the company says. “Currently, there is no FDA approved medicine for levodopa-induced dyskinesia for patients with Parkinson’s disease.”

  
ADS-5102 is a chrono-synchronous amantadine therapy. In 2015, the FDA granted orphan status for the drug and its use for this indication. Adamas is also investigating ADS-5102 for other indications earlier in the Parkinson’s treatment cycle, as well as for walking impairment in multiple sclerosis.