The Reagan-Udall Foundation for the FDA, in collaboration with the U.S. Food and Drug Administration, hosted a hybrid public meeting titled Understanding Current Use of Ketamine for Emerging Areas of Therapeutic Interest. The meeting brought together clinicians, researchers, patient advocates, federal partners, and professional organizations to examine the evolving use of ketamine in clinical settings.
Discussions focused on emerging therapeutic applications, safety considerations, and the growing online promotion and access to ketamine. Presenters also reviewed the science behind ketamine’s pharmacology—including its approved use as an anesthetic and its potential antidepressant effects—and considered regulatory pathways, such as the supplemental new drug application (sNDA), for expanding approved indications. Insights from esketamine (Spravato®) development were explored as a potential model for future regulatory review.
