FDA Approves Cannabis Based Drug

FDA Approves Cannabis Based Drug

The Dravet Syndrome Foundation is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved EPIDIOLEX® (cannabidiol /CBD) for the treatment of seizures associated with Dravet syndrome Lennox-Gastaut Syndrome (LGS) in patients two years age or older.

It's not only the first cannabis-derived medicine to be approved by the FDA, but also the first approval for a drug created to treat Dravet Syndrome, a condition accompanied by hyperactivity, impulsiveness, autistic type behaviours and other developmental disorders as well as seizures. Nevertheless, the Epidiolex approval process took many years. He continued, "In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition".

CBD is one component of the cannabis plant, but unlike tetrahydrocannabinol (THC), the compound that causes highs, it is non-psychotropic. This includes seizures from two types of rare epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.

It is estimated there are up to 18,500 patients with LGS, and 20,000 of Dravet Syndrome in the United states.

It is a purified form of cannabidiol (CBD), one of the hundreds of molecules found in marijuana.

"It's nice to have that the government hopefully will allow further research into CBD for not only epilepsy, but for a variety of other conditions".

The FDA's approval of this drug is highly newsworthy and will be of great interest not only for those seeking help for the rare seizure disorders the new drug, Epidiolex, is meant to treat, but also for other diseases and symptoms such as pain and nausea.

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GW Pharmaceuticals chief executive, Justin Gover said that the medicine is a prescription drug shown to reduce seizures in clinical trials. What's more likely is that the DEA reschedules CBD, while leaving THC and marijuana itself as a Schedule 1 substance.

The most common side effects from the drug were sleepiness, diarrhea, insomnia, elevated liver enzymes cause mild liver injury and infections. "This is how sound medical science is advanced".

Earlier today, FDA Commissioner Scott Gottlieb made similar observations in a prepared statement.

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.

Once that happens, marijuana startups will be able to sell their CBD-only products even in states where marijuana is illegal - as long as they register them with the DEA.

The other epilepsy drugs in the market lead to serious risks like suicidal thoughts and attempts.

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