Published: Wed, June 27, 2018
Medicine | By Earnest Bishop

FDA approves its first marijuana-derived drug

FDA approves its first marijuana-derived drug

The Food and Drug Administration on Monday approved the country's first drug derived from marijuana, a medication that treats two rare and devastating forms of epilepsy.

The FDA signed off on the use of Epidiolex, a drug from Britain's GW Pharmaceuticals, to treat two kinds of epilepsy.

It's made from a purified ingredient in cannabis called CBD oil. No clinical trials have proved that CBD can treat specific diseases.

The Food and Drug Administration approved the first cannabis-derived drug on Wednesday.

Not long after the NEJM report, GW Pharmaceuticals, which operates in the Greenwich Biosciences, applied for FDA approval of Epidiolex. The drug, Epidiolex, is meant to treat seizures resulting from Dravet syndrome and Lennox-Gastaut syndrome, two rare forms of epilepsy.

The medicinal acknowledgment of CBD should come as good news to marijuana startups eyeing the compound for consumer and medical consumption. The chemical's use in seizure prevention is well-documented in reputable research, and now, after conducting its own trials, the FDA is on board.

Although THC can induce paranoia, anxiety and hallucinations, CBD has the opposite effect and has been cited by scientists as a potential treatment for mental health issues. "Yet we were surprised at how robust the response was in this study", Dr. Anup Patel, a pediatric neurologist at Nationwide Children's Hospital in OH and one of the lead authors of the study, told ABC News.

At time of publication, GW Pharma shares had receded to trade down 1.7 percent on the day - a potential case of "buying the rumor, selling the news" considering GW's pre-approval run.

Javier Mascherano: Lionel Messi 'desperate' to turn things round with Argentina
Rebic, 24, was on top form for the Europeans as they humbled the two-time World Cup winners 3-0 at the Nizhny Novgorod Stadium. A life-size chocolate sculpture was unveiled at an event in Bronnitsy to mark Messi's 31st birthday.

A doctor talks to a patient in this undated stock photo. "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". Dravet Syndrome is confirmed with a genetic test.

"While these areas are at an earlier stage of development, the evidence we have, it's very much a science-led program", Gover said.

Dr. Nicholas Chadi, a pediatrician completing his fellowship at Boston Children's Hospital in pediatric and adolescent addictions, points to the limited research on CBD side effects in general.

Cannabidiol is one of more than 80 active cannabinoid chemicals, yet unlike tetrahydrocannabinol, or THC, it does not produce a high. It may also have far-reaching implications for USA marijuana policy. "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". The agency is expected to do so within 90 days. British drugmaker GW Pharmaceuticals expects the oral solution to hit the market this fall.

What should parents be aware of now? The FDA is willing to help companies that want to pursue such research programs, he said, but they need to prove their products work and are safe with data from clinical trials.

Most patients with LGS and DS require multiple seizure medications and the majority are resistant to now approved anti-epileptic drugs.

In Ohio, a bill in the Senate would remove drug schedules from state law and instead have the state pharmacy board schedule substances in rules and regulations. "They may also be contaminated with other things, so the safety, particularly for children, is concerning", Patel told ABC News.

It's an option for those patients who have not responded to other treatments to control seizures.

Like this: