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FDA approves prescription-grade CBD oil for rare epilepsy disorders

Author: Marianne Goodland - June 25, 2018 - Updated: June 25, 2018

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This file photo shows GW Pharmaceuticals’ Epidiolex, a medicine made from the marijuana plant but without THC. U.S. health regulators on June 25 approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law, despite growing legalization for recreational and medical use. (AP Photo/Kathy Young, File)

The Food and Drug Administration Monday gave its first-ever approval of a plant-based cannabidiol product — Epidiolex — for treating two rare seizure disorders that begin in childhood.

It’s not quite medical marijuana. The strawberry-flavored syrup is a purified form of a chemical ingredient found in the cannabis plant — but not the one that gets users high. It’s not yet clear why the ingredient, called cannabidiol, or CBD, reduces seizures in some people with epilepsy.

The approval is the first of two major steps that could clear the way for parents to obtain medical prescriptions for CBD oil, a process also put into place by the Colorado General Assembly during the 2018 session.

Epidiolex is produced by U.K.-based GW Pharmaceuticals. According to an FDA statement, it’s the first time the agency has approved a drug “that contains a purified drug substance derived from marijuana.” CBD is one of more than 100 chemicals found in marijuana. But it doesn’t contain THC, the ingredient that gives marijuana its mind-altering effect.

British drugmaker GW Pharmaceuticals studied the drug in more than 500 children and adults with hard-to-treat seizures, overcoming numerous legal hurdles that have long stymied research into cannabis.

FDA officials said the drug reduced seizures when combined with older epilepsy drugs.

The two seizure disorders that could be treated with Epidiolex are Lennox-Gastaut and Dravet syndromes. Some patients already use CBD oil that does not require a doctor’s prescription to treat the condition.

Bfore Epidiolex can be prescribed, the Drug Enforcement Agency (DEA) must remove CBD from its list of Schedule 1 drugs. Currently, CBD oil is considered a dangerous drug along with marijuana, heroin, LSD and several other drugs that the DEA says have “no currently accepted medical use and a high potential for abuse.” The DEA considers CBD a marijuana extract, even though proponents point out that it also can come from hemp, which usually lacks the THC content necessary to produce the psychotropic effects of marijuana.

The clock is ticking. With Monday’s FDA decision, the DEA has only 90 days to decide whether to change the CBD schedule. A federal lawsuit is challenging the DEA’s 2016 decision to classify CBD as a marijuana extract.

FDA approval (and the DEA change that must also take place) means that some parents who were reluctant to try CBD oil may be more willing to do so if it is prescribed by a doctor and covered by health insurance, according to Heather Jackson of the Realm of Caring Foundation. The Foundation was set up by the creators of Charlotte’s Web, one of the first CBD products used to treat Dravet syndrome.

Should the DEA reschedule CBD oil, Coloradans with the rare disorders will be able to have the drug prescribed. That’s because the General Assembly passed a bill during the 2018 session that changes state law to remove from the criminal code FDA-approved drugs prescribed by a healthcare provider.

House Bill 1187 initially raised concerns for the hemp industry because the bill, as introduced, appeared to benefit only GW Pharmaceuticals and had potential unintended consequences for the hemp industry. The bill was amended, in part to assuage those concerns. Gov. John Hickenlooper signed it into law on June 4.

Democratic Rep. Jonathan Singer of Longmont said Monday the FDA decision showed “the federal government is willing to take reasonable steps to make sure patients can access drugs that are safe. It’s a shame that cannabis is still Schedule I, but I’ll take a baby step over no steps.”

According to GW CEO Justin Glover, the FDA 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. These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”

Glover acknowledged the last hurdle is the DEA’s rescheduling, but the company said it expects that will happen in the next 90 days and that the drug will be available to patients by this fall.

The Associated Press contributed to this report.

Marianne Goodland

Marianne Goodland