Published: Thu, June 28, 2018
Health Care | By Alice Shelton

FDA Approves First-Ever Cannabis-Based Drug

FDA Approves First-Ever Cannabis-Based Drug

The drug, GW Pharmaceuticals' Epidiolex, is made of cannabidiol, or CBD, a component of marijuana that does not give users a high. The FDA has okayed the sale of Epidiolex to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years old or older.

GW CEO Justin Gover said: "This approval is the culmination of GW's many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine".

Epidiolex would also be the first approved therapy for DS, treatments for which are now limited to a combination of seizure medication and drugs to prevent emergencies.

Lennox-Gastaut syndrome and Dravet syndrome - conditions that both begin in childhood - cause frequent seizures and severely impact patients' quality of life.

"This product approval demonstrates that advancing sound scientific research to investigate ingredients derived from marijuana can lead to important therapies". The trials included 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome.

CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana.

Marijuana has always been known to be effective in reducing the frequency of seizures in some patients; and many patients buy medical grade marijuana in states where it is legal as treatment. The report by Stat goes on to add that analysts predict the drug might be used to treat forms of epilepsy other than DS and LGS. The FDA noted in its announcement today that it informs and advises the DEA about scheduled substances.

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The most common side effects of Epidiolex include diarrhea, rash, insomnia, and infections.

Krane said that Epidiolex would probably be more expensive than CBD treatments within a state medical program, which typically costs $200 to $500 a month.

CBD is one of more than 80 compounds found in the marijuana plant, according to a statement from Scott Gottlieb, MD, FDA commissioner. Supporters of the FDA's Epidiolex approval mark it as a major medical milestone, and are hopeful that this will open the doors to further research of cannabis as a medical cure for other ailments. "This is the approval of one specific CBD medication for a specific use", Gottlieb said.

Patients age 2 and up will be able to use the drug.

"It wouldn't have as full of a cannabinoid panel as Charlotte's Web hemp oil has, and so we would really need to think long and hard about switching her from a natural product to a pharmaceutical CBD", Gaer said.

This drug is also likely to be available made in the United Kingdom and Europe market from mid of 2019, though overtly subject to regulatory approval from European Medicines Agency in early next year.

He said, "Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases".

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