The FDA has Approved the First Marijuana-Based Drug in the US

FDA Approves First Cannabis Based Drug

FDA Approves First Cannabis Based Drug

The U.S. Food and Drug Administration has approved a marijuana-based drug for the first time, pacing the way for more research into an ingredient that is still illegal in federal law despite increasing legalization for medical and recreational purposes.

The move marks several firsts. Therefore, patients will not be able to access Epidiolex until CBD is rescheduled by the DEA, which is expected to take place within 90 days, according to GW Research Ltd. Epidiolex is the first cannabis-based drug to be legalized in the United States.

Currently, CBD is classified as a Schedule I drug, which are substances with a high potential for abuse and no accepted medicinal use.

"The FDA will continue to support rigorous scientific research on potential medical treatments using marijuana and its components that seek to be developed through the appropriate scientific channels", FDA Commissioner Scott Gottlieb said in a Monday press release.

GW's CEO Justin Gover called the approval a "historic milestone" that will offer a treatment for patients suffering from two severe forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.

The drug, which will become available this fall, will hopefully be a wonderful option for parents of epilepsy patients who have, until now, had their hands tied when it comes to improving their kid's quality of life.

"This is clearly a breakthrough drug for an bad disease", John Mendelson, a panel member and senior scientist at the Friends Research Institute, said at a public FDA meeting this spring that was called to discuss the scientific merits of the drug.

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.

LGA and Dravet syndrome develop in childhood and are rare, severe forms of epilepsy that are notoriously hard to treat.

The most common side effects from the drug were sleepiness, diarrhea, insomnia, elevated liver enzymes cause mild liver injury and infections. The agency explained that the drug contains CBD, and not THC, and is hence not psychoactive in any way.

In one clinical trial (published by The New England Journal of Medicine), Epidiolex reduced monthly drop seizures by 37.2 percent (10 mg/kg/day dose) and 41.9 percent (20 mg/kg/day), compared with a 17.2 percent reduction for placebo.

The drug is made from purified cannabidiol, or CBD, a compound found in the cannabis plant. "And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition", he said.

Some have said that they have no intention of switching to the new prescription CBD drug because the products they're using are helping their children. "It's being delivered to patients in a reliable dosage form and through a reproducible route of delivery".

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