Psychiatric Times October 9, 2023
The FDA has released a draft guide to offer their perspective and thoughts on the development of treatments for stimulant use disorder.
The US Food and Drug Administration (FDA) published a new draft guidance to assist in the development of treatments for stimulant use disorders: Stimulant Use Disorders: Developing Drugs for Treatment. This will be the first guide that contains the FDA’s recommendations on the development program and clinical trial design for drugs intended for the treatment of cocaine use disorder, methamphetamine use disorder, and prescription stimulant use disorder.1
Thomas R. Kosten, MD, the Jay H. Waggoner Endowed Chair and co-founder at the Institute for Clinical and Translational Research, offered his thoughts on the draft’s release:
“This is excellent news...