FDA approves first marijuana-based drug

Epidiolex a medicine made from the marijuana plant but without THC

FDA approves first ever drug derived from marijuana | TheHill

Epidiolex is now the first FDA-approved drug made up of a purified drug substance extracted from marijuana.

Shaun Hussain, MD, a pediatric neurologist at Ronald Reagan UCLA Medical Center in Santa Monica, says that while the FDA's approval of a marijuana-based drug is "indeed a big deal", it is also significant because "it offers another drug for Lennox-Gastaut and the first-ever drug for Dravet".

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Epidiolex is derived from cannabidiol, or CBD, an active chemical compound in marijuana that reduces the frequency of seizures.

Gottlieb stresses that clinical trials that are careful and being controlled, combined with the FDA's strict process of drug approval as the best way to deliver marijuana treatments to the public. He described it as the 'first and only FDA-approved cannabidiol medicine to treat two severe, childhood-onset epilepsies'. They're defined as substances with high abuse potential and "no now accepted medical use". As noted in the FDA's announcement approving Epidiolex, "m$3 arketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases". This is a type of oral solution for the treatment of seizures. More than three-quarters of affected individuals have tonic seizures, which cause the muscles to contract uncontrollably.

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Lennox-Gaustaut syndrome is estimated to account for between one and four percent of all cases of childhood epilepsy. Both genetic conditions are characterized by frequent seizures and reduced motor skills, including sitting and crawling. The medicine is now approved in the U.S. for treatment of seizures due to Lennox-Gastaut and Dravet syndromes, which are both severe forms of epilepsy. The drug will be marketed under the brand name Epidiolex. There are six other drugs approved to treat seizures associated with Lennox-Gastaut, but none approved for Dravet. The drug went through three randomized, double-blind, placebo-controlled clinical trials to determine its effectiveness in treating the two diseases. Some of the side effects of treatment with Epidiolex included, among other, sleepiness, lethargy, diminished appetite, rashes, and infections. The new drug is anticipated to become available to patients later this fall.

LGA and Dravet syndrome develop in childhood and are rare, severe forms of epilepsy that are notoriously hard to treat. More severe liver injury can cause nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice and/or dark urine. For instance, a clinical trial is underway to test whether CBD can be an effective treatment for people with post-traumatic stress disorder and alcohol use disorder. The FDA "provides recommendations" to the DEA on scheduled substances, so it's likely that CBD will be reclassified as a Schedule 2 substance, opening the door for GW to market and sell Epidiolex.

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