FDA Approved Cannabinoids
Marinol (dronabinol)
AbbVie Inc.
Schedule III Controlled Substance
Unimed Pharmaceuticals, a subsidiary of Solvay Pharmaceuticals, was initially granted approval in 1985 for Marinol in a fixed-dose pill form for nausea. In 1992, appetite stimulation was added to its indications. It was classified as a Schedule I drug until it was moved to Schedule III in 1999. Marinol is manufactured by Patheon Softgels, Inc., for Abbvie Inc.
Schedule III Controlled Substance
Seizure and seizure-like activity have been reported in patients receiving dronabinol.
Syndros (dronabinol solution) oral solution
Insys Therapeutics, Inc.
Schedule II Controlled Substance
50% w/w dehydrated alcohol, propylene glycol, polyethylene glycol 400, sucralose, methyl paraben, propyl paraben, BHA, water
Seizures and seizure-like activity have been reported in patients receiving dronabinol.
Cesamet (nabilone)
Meda Pharmaceuticals, Inc. (Valiant Pharmaceuticals)
Schedule II Controlled Substance
No mention of seizures in package insert.
AbbVie Inc.
Schedule III Controlled Substance
Unimed Pharmaceuticals, a subsidiary of Solvay Pharmaceuticals, was initially granted approval in 1985 for Marinol in a fixed-dose pill form for nausea. In 1992, appetite stimulation was added to its indications. It was classified as a Schedule I drug until it was moved to Schedule III in 1999. Marinol is manufactured by Patheon Softgels, Inc., for Abbvie Inc.
Schedule III Controlled Substance
Seizure and seizure-like activity have been reported in patients receiving dronabinol.
Syndros (dronabinol solution) oral solution
Insys Therapeutics, Inc.
Schedule II Controlled Substance
50% w/w dehydrated alcohol, propylene glycol, polyethylene glycol 400, sucralose, methyl paraben, propyl paraben, BHA, water
Seizures and seizure-like activity have been reported in patients receiving dronabinol.
Cesamet (nabilone)
Meda Pharmaceuticals, Inc. (Valiant Pharmaceuticals)
Schedule II Controlled Substance
No mention of seizures in package insert.
Epidiolex (Cannabidiol)
Abuse Liability Studies
FDA analysis of preclinical and clinical abuse liability studies are discussed in FDA slides from April 19, 2018 advisory meeting, available here.
FDA analysis of preclinical and clinical abuse liability studies are discussed in FDA slides from April 19, 2018 advisory meeting, available here.