The medical marijuana field saw a landmark U.S. regulatory approval for two rare childhood epilepsy conditions in 2018, but a year later, investors and scientists continue to harbor doubts about cannabis-based medicines — especially when used to treat children.
Concerns primarily surround tetrahydrocannabinol, or THC, the psychoactive component of cannabis. But worries have also shifted to nonpsychoactive cannabidiol. Purified CBD is the basis of GW Pharmaceuticals PLC's Epidiolex for treatment-resistant inherited epilepsies, which was approved by the U.S. Food and Drug Administration in June 2018.
Cannabis remains a Schedule I substance, the most stringent drug classification, meaning it poses a risk of abuse and has no acceptable medical use. Epidiolex, though, which contains no THC, was reclassified in the lowest restriction classification, Schedule V.
The U.S. Surgeon General in August issued a warning against cannabis use in adolescents and pregnant women, specifically highlighting THC's potentially harmful effects on brain development.
Epilepsy patient advocates and others have sought to broaden access to cannabis and its plant-derived constituents, called cannabinoids, whether that entails descheduling the substance, legalizing it or simply making it available to patients.
"There's so much misinformation out there," said Catherine Jacobson, vice president of regulatory and medical affairs at medical cannabis company Tilray Inc.
Investors doubt cannabis-based epilepsy drugs for children 1 year after approval
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