The FDA news signals that the DEA will likely adjust its scheduling for CBD, which is now a Schedule I substance, denoting high potential for abuse and no medical applications. Accordingly, before Epidiolex is ready for use amongst patients, it needs to be appropriately reclassified - something GW Pharmaceuticals expects to see happen within the next three months.
"This is an important medical advance", Gottlieb said.
Treatments available for both disorders are far from flawless and some patients resort to buying "self-prescribed" CBD online or from unregulated vendor sites, Dr. Pavel Klein, founder of the Mid-Atlantic Epilepsy and Sleep Center, said.
While most hemp-derived CBD companies are rapidly growing their businesses without repercussion or worry, many cannabis CBD businesses are hesitant about selling products in states where marijuana is not yet legal.More news: Blast at Addis Ababa rally for new Ethiopian prime minister - Reuters witness
"The DEA will need to make a different scheduling decision for CBD.because it now has an accepted medical use", he said during a conference call with reporters.
GW Pharmaceuticals manufactures another cannabis-derived drug, Sativex, which helps treat muscle spasms from multiple sclerosis.
Carson says he will likely prescribe Epidiolex going forward. As well, CBD remains in a legal grey area, making it hard for patients outside of legal states to acquire. Agency officials paved the way for the cannabis-based drug by defending its effects in a briefing document, writing, "In general, the risks associated with CBD treatment appear acceptable, particularly given the findings of clinical efficacy in LGS and DS, which are serious, debilitating, and life-threatening disorders".More news: Prince Harry Visits Africa Without Meghan Markle for Solo Charity Trip
Gottlieb hinted at additional enforcement actions against companies that sell unregulated CBD products with medical claims that aren't backed up by evidence.
The medication, which will continue to be manufactured in Britain, will be marketed by Greenwich Biosciences, the USA subsidiary of GW Pharmaceuticals.
The FDA is not required to follow the advisory panel's advice but usually does. "Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug's uniform strength and consistent delivery". Others said they are anxious to try an FDA-approved product.
The component in this newly approved drug is CBD (cannabidiol), which is part of the sativa marijuana plant. A bill was introduced to the House a year ago to legalize the use of marijuana, but it has yet to reach the floor for vote.More news: Toronto Pride Parade to kick off amid tensions between LGBTQ community, police