Dronabinol

Dronabinol is the International Nonproprietary Name for synthetic (−)-trans-Δ9-tetrahydrocannabinol (THC), the principal psychoactive cannabinoid in Cannabis sativa produced as a pharmaceutical active ingredient. The U.S. Food and Drug Administration first approved dronabinol on May 31, 1985 for chemotherapy-induced nausea and vomiting (CINV) refractory to conventional antiemetics, and expanded the indication in 1992 to include anorexia associated with weight loss in patients with AIDS. Dronabinol-in-sesame-oil soft gelatin capsules (Marinol) were moved from Schedule II to Schedule III of the Controlled Substances Act on July 2, 1999 (64 FR 35928), based on low diversion and a formulation resistant to manipulation. An oral solution formulation, Syndros, was approved on July 1, 2016 and placed in Schedule II in March 2017 because the liquid is more easily manipulated for extra-oral routes (82 FR 14815). Marinol is currently marketed by AbbVie; Syndros was originally marketed by Insys Therapeutics and is now held by Benuvia Therapeutics. → See also: Marinol, Syndros, THC.