Challenges to Clinical Trials Remain Following First FDA Cannabis-Based Drug Approval

Although a big step has been taken now that the U.S. Food and Drug Administration (FDA) has approved a cannabis-based drug for the first time, one researcher with experience in cannabis studies says how cannabidiol (CBD), the main ingredient behind the effects of such drugs, is classified in the U.S. and Canada will continue to complicate the conduct of clinical trials for potential new treatments. The FDA on June 25 approved Epidiolex as a twice-daily oral solution for use in treating two types of epileptic syndromes: Dravet syndrome and Lennox-Gastaut syndrome. FDA Commissioner Dr. Scott Gottlieb was on record as praising the “adequate and well-controlled clinical studies” that supported the drug’s approval. “I hope studies like these push other changes, including recognizing that CBD does not have psychoactive effects, and hopefully helps to reschedule CBD from a Class 1 drug in the U.S. and from a Class 2 drug in … Continue reading Challenges to Clinical Trials Remain Following First FDA Cannabis-Based Drug Approval