As a result, Epidiolex's launch remains at the discretion of the DEA which must now evaluate the drug and consider reclassifying it as a substance that has medical properties, which would allow GW to begin selling it. The drug contains only trace amounts of the psychoactive element THC and does not induce euphoria.
The FDA's decision was not unexpected, as the proprietary extract formulation - developed by the British biotechnology firm GW Pharmaceuticals - had previously demonstrated safety and clinical efficacy at reducing seizure frequency in several placebo-controlled trials.
"This is an important medical advance", Gottlieb said. We'll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products.
That's because these kids did not experience as many side effects from the cannabidiol, which can include tiredness, decreased appetite, diarrhea and signs of possible liver damage, Devinsky explained.
A government-regulated version of the oil will ease some doubts about the amount of CBD in the product, which can vary based on its origin, said Dr. Elaine Wirrell, director of the Mayo Clinic's child epilepsy program. It's in phase 3 testing for a potential approval in the U.S. The company is also working on cannabinoid programs against glioblastoma, schizophrenia and more.
In the meantime, it is possible that once on the market, Epidiolex could be prescribed for conditions other than the ones it's approved for.
"Compared to other drugs used to treat epilepsy, I think Epidiolex, which is 99-percent pure cannabidiol, has a better side-effect profile than numerous available drugs", Devinsky said.
Gottlieb hinted at additional enforcement actions against companies that sell unregulated CBD products with medical claims that aren't backed up by evidence.
Two months after a unanimous recommendation by an outside group of FDA experts and some glowing recommendations in the internal review, GW will now set out to open up a new class of meds after demonstrating the drug's ability to prevent seizures in children suffering from rare cases of Lennox-Gastaut syndrome and Dravet syndrome.
GW Pharmaceuticals says it is not their intention to shut out other marijuana products and that they only want to make sure their medicine is accessible. Others said they are anxious to try an FDA-approved product. A prescription drug provides a workaround to this issue. The chemical's use in seizure prevention is well-documented in reputable research, and now, after conducting its own trials, the FDA is on board.
The FDA's decision was expected. A study at the end of past year found that almost 70 percent of CBD products sold online were mislabeled. And the company plans to continue importing the medicine, bypassing onerous USA regulations on manufacturing restricted substances.