Marijuana-based drug gets positive review from US agency

April 17, 2018 by Matthew Perrone
Marijuana-based drug gets positive review from US agency
This May 23, 2017, file photo shows GW Pharmaceuticals' Epidiolex, a medicine made from the marijuana plant but without TCH. The medicine reduced seizures in children with severe forms of epilepsy and warrants approval in the United States, health officials said Tuesday, April 17, 2018. (AP Photo/Kathy Young, File)

A closely watched medicine made from the marijuana plant reduces seizures in children with severe forms of epilepsy and warrants approval in the United States, health officials said Tuesday.

British drugmaker GW Pharmaceuticals is seeking permission to sell its purified form of an ingredient found in cannabis—one that doesn't get users high—as a medication for rare, hard-to-treat seizures in children. If successful, the company's liquid formula would be the first government-approved drug derived from the cannabis plant in the U.S.

The Food and Drug Administration's approval would technically limit the treatment to a small group of epilepsy patients. But doctors would have the option to prescribe it for other uses and it could spur new pharmaceutical research and interest into other cannabis-based products. Man-made versions of a different marijuana ingredient have previously been approved for other purposes.

The FDA posted its review of the experimental medication Epidiolex ahead of a public meeting Thursday when a panel of outside experts will vote on the medicine's safety and effectiveness. It's a non-binding recommendation that the FDA will consider in its final decision by late June.

Patients taking the treatment had fewer seizures, according to the FDA's internal review posted online. Scientists concluded that GW Pharmaceutical's submission "appears to support approval" despite some potential side effects including risks of liver injury.

More than two dozen states allow marijuana use for a variety of ailments, but the FDA has not approved it for any medical use. In 2016, the agency recommended against easing federal restrictions on marijuana. The U.S. continues to classify marijuana as a high-risk substance with no medical use, alongside other illicit drugs like heroin and LSD.

For years, desperate patients and parents have pushed for wider access to medical marijuana products for a host of conditions including pain, post-traumatic stress disorder and epilepsy, with only anecdotal stories and limited studies on their side.

But studies conducted by GW Pharmaceuticals have begun to change that picture.

Across three studies involving more than 500 patients, Epidiolex generally cut the number of monthly seizures by about 40 percent, compared with reductions between 15 and 20 percent for patients taking a dummy medicine.

Most patients in the study were already taking at least three other medications to try and control their seizures.

Marijuana-based drug gets positive review from US agency
In this Feb. 14, 2018, file photo, marijuana plants are displayed at a dispensary in Berkeley, Calif. U.S. health officials say a closely watched medicine made from the marijuana plant significantly reduces seizures in children with severe forms of epilepsy and warrants approval in the U.S. The Food and Drug Administration posted its review Tuesday, April 17, of the experimental medication ahead of a public meeting later this week. (AP Photo/Marcio Jose Sanchez, File)

Epidiolex is essentially a pharmaceutical-grade version of cannabidiol, or CBD oil, which some parents have used for years to treat children with epilepsy. CBD is one of more than 100 chemicals found in the cannabis plant and it doesn't contain THC, the ingredient that gives marijuana its mind-altering effect.

CBD oil is currently sold online and in specialty shops across the U.S., though its legal status remains murky. Most producers say their oil is made from hemp, a plant in the cannabis family that contains little THC and can be legally farmed in a number of states for clothing, food and other uses.

A doctor who treats children with epilepsy says it's important to have an FDA-approved version of CBD.

"I think it needs to be approved because everyone is using it across the internet without knowing the safety ... and no one is watching the interactions with other drugs," said Dr. Joan Conry of Children's National Health System in Washington, who was not involved in the studies.

Conry and other researchers say it's not yet clear why CBD reduces seizures in some patients.

GW Pharmaceuticals makes its drug from cannabis plants that are specially bred to contain high levels of CBD. It's seeking approval for two rare forms of childhood epilepsy—Dravet and Lennox-Gastaut syndromes.

Common side effects included diarrhea, vomiting, fatigue and sleep problems. FDA reviewers flagged a more serious issue with potential liver injury, but said doctors could manage the risk by monitoring patients' enzyme levels.

Explore further: Cannabis compound reduces seizures

Related Stories

Cannabis compound reduces seizures

February 27, 2018
About one third of patients treated for epilepsy continue to have seizures. Cannabidiol (CBD), one of the many active compounds in the cannabis (marijuana) plant, has gained attention as a treatment for epilepsy. Purified ...

Cannabis use in people with epilepsy revealed: Australian survey

March 9, 2017
People with epilepsy resort to cannabis products when antiepileptic drug side-effects are intolerable and epilepsy uncontrolled.

US doctors call for more study of pot for seizures (Update)

March 3, 2014
A medical group of epilepsy experts on Monday called on the U.S. government to reconsider classifying marijuana as a dangerous drug so its impact on seizures can be studied.

Nearly all cannabis seized by UK police is high-strength 'skunk'– here's why we should be worried

February 28, 2018
Fully 94% of the cannabis seized by British police in 2016 was high-potency cannabis known as "skunk", our latest research reveals. By comparison, skunk comprised 85% of cannabis seized in 2008, and just 51% in 2005. This ...

Medical marijuana gains ground globally

December 23, 2015
Colombia became on Tuesday the latest in a growing number of nations around the world to legalise the use of cannabis for medical reasons.

Greece set to allow medical cannabis use

January 14, 2018
Greece's parliament is expected to approve the medical use of cannabis in the coming weeks, a deputy minister said Sunday, adding that the change would attract investment to the country.

Recommended for you

Text messaging tool may help fight opioid epidemic

April 17, 2018
A new automated text messaging service may curb opioid abuse and reduce the likelihood of relapse while also decreasing treatment costs, according to researchers at Washington University School of Medicine and Epharmix, a ...

Marijuana-based drug gets positive review from US agency

April 17, 2018
A closely watched medicine made from the marijuana plant reduces seizures in children with severe forms of epilepsy and warrants approval in the United States, health officials said Tuesday.

Post-surgical opioids can, paradoxically, lead to chronic pain

April 16, 2018
Giving opioids to animals to quell pain after surgery prolongs pain for more than three weeks and primes specialized immune cells in the spinal cord to be more reactive to pain, according to a new study by the University ...

Animal study suggests common diabetes drug may also help with nicotine withdrawal

April 5, 2018
In a mouse study, a drug that has helped millions of people around the world manage their diabetes might also help people ready to kick their nicotine habits.

20 years after Viagra, Pfizer seeks another miracle drug

April 1, 2018
It has been 20 years since Viagra was introduced, and Pfizer is still searching for another drug with as much earning power as the revolutionary blue erection pill.

Non-addictive pain medication changing therapy for substance use disorders

March 30, 2018
"It's not often that a psychiatrist gets to hear 'Doctor, you saved my life,' " said Ellen Edens, M.D., FW '09, assistant professor of psychiatry and associate fellowship director in addiction psychiatry. But she gets that ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.