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# PharmaTher to Work with FDA on Ketamine Phase 3 Study
- URL: https://www.fdaweb.com/pharmather-to-work-with-fda-on-ketamine-phase-3-study/
- Published: 2022-03-23T12:00:00.000Z
- Updated: 2026-09-14T17:37:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151435

PharmaTher says topline results from a dose-finding and tolerability clinical study of ketamine for treating levodopa-induced dyskinesia (LID) in Parkinson’s patients were sufficient for the company to engage FDA to establish next steps for a planned Phase 3 study to allow for ketamine’s approval under the 505(b)(2) regulatory pathway. A company [statement](https://www.marketwatch.com/press-release/pharmather-announces-positive-topline-results-from-clinical-study-of-ketamine-for-parkinsons-disease-2022-03-23?mod=search%5Fheadline&ref=fdaweb.com) says it will use its proprietary intravenous product Ketarx for the planned Phase 3 study.

The study evaluated the safety, tolerability, and efficacy of low-dose ketamine infusion for the treatment of LID in patients with Parkinson’s disease. PharmaTher reports that 100% of patients treated with ketamine demonstrated a reduction in dyskinesias. Ketamine was well tolerated with no serious adverse events reported, it says.