FDA Commissioner Scott Gottlieb said the approval was "a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies".
Why? Because their product and company status will no longer exist in the legal gray area, and hopefully the mass confusion over which CBD products are legal and which are not will come to an end.
Even though 16 percent of trial participants experienced unwelcome side effects, such as diarrhea, vomiting and abnormal liver function, FDA officials and an advisory panel unanimously recommended its approval.
A mother feeds her epileptic son, whom she treats with medical marijuana, in Siedlce, Poland, in October 2017.
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"I don't know a mom or dad in their right mind who is going to change what's already working", said Heather Jackson, CEO of Realm of Caring, a charitable group affiliated with Colorado-based CW Hemp, one of nation's largest CBD companies.
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.
Patel helped run trials here testing Epidiolex to treat Dravet syndrome and Lennox-Gastaut syndrome, two rare, often drug-resistant forms of epilepsy that start in childhood.
Epidiolex won't require a special certification to prescribe, Patel said, and it's likely physicians will prescribe it for off-label uses. That so-called "high" comes from a different compound in marijuana, known as tetrahydrocannabinol (THC). "And, the FDA is committed to this kind of careful scientific research and drug development", said Gottlieb.
The FDA previously issued warnings to CBD producers that claimed their products could treat specific diseases, such as cancer or Alzheimer's. British drugmaker GW Pharmaceuticals expects the oral solution to hit the market this fall. 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 that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. The FDA has approved the first medication containing marijuana for patients with rare forms of epilepsy.
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Despite increasing acceptance, there is little rigorous research on the benefits and harms of marijuana.
Now with the approval of Epidiolex, a drug that will not produce an euphoric "high" feeling in the user - Devinsky said he expected CBD would be moved down to a schedule 4 or 5 drug, which is one that poses a low potential for abuse and dependence. "We want the whole-plant extracts that our kids are using and that have worked for them for years".
Federal agencies have 90 days to determine the scheduling of Epidiolex.
The European Medicines Agency is expected to rule on the therapy in early 2019.
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