FDA approves first cannabis-based drug

1 year 5 months 1 week ago Monday, June 25 2018 Jun 25, 2018 Monday, June 25, 2018 12:53:00 PM CDT June 25, 2018 in News
By: Debra Goldschmidt and Susan Scutti, CNN

    (CNN) -- The US Food and Drug Administration approved a cannabis-based drug for the first time, the agency said Monday.

Epidiolex was recommended for approval by an advisory committee in April, and the agency had until this week to make a decision.

The twice-daily oral solution is approved for use in patients 2 and older to treat two types of epileptic seizures: Dravet syndrome, a rare genetic dysfunction of the brain that begins in the first year of life, and Lennox-Gastaut syndrome, a form of epilepsy with multiple types of seizures that begin in early childhood, usually between 3 and 5.

"This is an important medical advance," FDA Commissioner Dr. Scott Gottlieb said in a statement Monday. "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 drug is the "first pharmaceutical formulation of highly-purified, plant-based cannabidiol (CBD), a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs," according to a statement Monday from GW Pharmaceuticals, the UK-based biopharmaceutical company that makes Epidiolex.

Cannabidiol is one of more than 80 active cannabinoid chemicals, yet unlike tetrahydrocannabinol, or THC, it does not produce a high.

The FDA has approved synthetic versions of some cannabinoid chemicals found in the marijuana plant for other purposes, including cancer pain relief.

Justin Gover, chief executive officer of GW Pharmaceuticals, described the approval in the statement as "a historic milestone." He added that the drug offers families "the first and only FDA-approved cannabidiol medicine to treat two severe, childhood-onset epilepsies."

"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," Gover said.

Epidiolex will become available in the fall, Gover told CNN. He would not give any information on cost, saying only that it will be discussed with insurance companies and announced later.

With Epidiolex meeting FDA standards, the drug will "finally be made available to the thousands that may benefit from it," he said.

It's an option for those patients who have not responded to other treatments to control seizures. According to the Epilepsy Foundation, up to one-thirdof Americans who have epilepsy have found no therapies that will control their seizures.

Shauna Garris, a pharmacist, pharmacy clinical specialist and adjunct assistant professor at the University of North Carolina's Eshelman School of Pharmacy, said the drug is effective and works somewhere between "fairly" and "very well." She has not used Epidiolex in her own clinical practice and was not involved in the development of the drug but said she's not sure it will live up to "all of the hype" that has surrounded it.

There are side effects, the most common being sleepiness, Gover said. But Garris highlighted that many of the side effects occur when it is taken with other medications, which she said is a concern because most patients are on other medications.

There are likely to be drug interactions, she said, but "that's not uncommon for antiepileptic medications," and she noted that this could affect the effectiveness of the medication.

The European Medical Society is also considering approval of Epidiolex and is expected to announce a decision in the first quarter of next year, according to Gover.

A phase three clinical trial is underway for a third seizure-related condition called tuberous sclerosis complex, which begins in infancy and causes a sudden stiffening of the body, arms and legs, with the head bent forward. Glover said that if the results are positive, his company will apply for supplemental approval for this condition.

In the meantime, it is possible that once on the market, Epidiolex could be prescribed for conditions other than the ones it's approved for. This is called off-label use and is a common practice with many medications.

As part of the FDA's review of the medication, the potential for abuse was assessed and found to be low to negative, according to Gover.

Still, this approval comes as the White House is said to be reconsidering federal prohibition of marijuana and as more and more states approve it for recreational and medicinal use.

Gover said the approval signals "validation of the science of cannabinoid medication."

The-CNN-Wire™ & © 2018 Cable News Network, Inc., a Time Warner Company. All rights reserved.

More News

Grid
List
FULTON - The 71st annual Christmas parade took over the streets of Fulton on Saturday afternoon. This year's theme... More >>
3 hours ago Saturday, December 07 2019 Dec 7, 2019 Saturday, December 07, 2019 3:40:00 PM CST December 07, 2019 in News
COLUMBIA - Road signs honoring five Boone County veterans killed in combat in Iraq or Afghanistan were revealed Saturday. ... More >>
3 hours ago Saturday, December 07 2019 Dec 7, 2019 Saturday, December 07, 2019 3:36:00 PM CST December 07, 2019 in News
CAMDEN COUNTY — One person was transported to the hospital Friday night after being ejected from their vehicle. The... More >>
3 hours ago Saturday, December 07 2019 Dec 7, 2019 Saturday, December 07, 2019 3:17:00 PM CST December 07, 2019 in News
TIPTON — A shooting suspect is in the hospital after authorities shot him five times, according to a news release... More >>
10 hours ago Saturday, December 07 2019 Dec 7, 2019 Saturday, December 07, 2019 8:50:00 AM CST December 07, 2019 in News
FULTON - Police are investigating after shots were fired at a Break Time in Fulton Friday night. According to... More >>
17 hours ago Saturday, December 07 2019 Dec 7, 2019 Saturday, December 07, 2019 1:25:00 AM CST December 07, 2019 in News
COLUMBIA - MU spokesman Christian Basi, confirmed the man who died after being hit by a car on College Ave... More >>
21 hours ago Friday, December 06 2019 Dec 6, 2019 Friday, December 06, 2019 9:34:00 PM CST December 06, 2019 in News
COLUMBIA - The Central Missouri Humane Society is waiving adoption fees this weekend, just in time for the holiday season.... More >>
1 day ago Friday, December 06 2019 Dec 6, 2019 Friday, December 06, 2019 6:36:00 PM CST December 06, 2019 in News
MISSOURI - Missouri’s minimum wage rate is set to go up again soon. The state minimum wage will increase... More >>
1 day ago Friday, December 06 2019 Dec 6, 2019 Friday, December 06, 2019 5:21:41 PM CST December 06, 2019 in News
JEFFERSON CITY - Governor Mike Parson and First Lady Teresa Parson are inviting families to join them at the Governor's... More >>
1 day ago Friday, December 06 2019 Dec 6, 2019 Friday, December 06, 2019 3:50:00 PM CST December 06, 2019 in News
BOONEVILLE - The Cooper County Sheriff's Office is asking travelers to find an alternate route on Highway 41 going to... More >>
1 day ago Friday, December 06 2019 Dec 6, 2019 Friday, December 06, 2019 3:02:00 PM CST December 06, 2019 in News
COLUMBIA - Former Columbia police chief Ken Burton has pleaded guilty to a misdemeanor after originally being charged with driving... More >>
1 day ago Friday, December 06 2019 Dec 6, 2019 Friday, December 06, 2019 2:45:00 PM CST December 06, 2019 in News
HALLSVILLE - Kari Hallowell, the mother of 17-year-old Hayden Holt, who died in an overnight car crash after being chased... More >>
1 day ago Friday, December 06 2019 Dec 6, 2019 Friday, December 06, 2019 2:04:00 PM CST December 06, 2019 in News
PENSACOLA, Fla. (AP)- Two U.S. officials have identified the shooter at the Naval Air Station in Pensacola as a second... More >>
1 day ago Friday, December 06 2019 Dec 6, 2019 Friday, December 06, 2019 1:53:00 PM CST December 06, 2019 in News
COLUMBIA - This weekend, 47 high school basketball teams from five states will go head-to-head in the 2019 Norm Stewart... More >>
1 day ago Friday, December 06 2019 Dec 6, 2019 Friday, December 06, 2019 1:24:00 PM CST December 06, 2019 in News
COLUMBIA- Former MU Quarterback Drew Lock is set to make his second start with the Denver Broncos this Sunday versus... More >>
1 day ago Friday, December 06 2019 Dec 6, 2019 Friday, December 06, 2019 12:28:00 PM CST December 06, 2019 in Sports
BOONE COUNTY- A 52-year-old male suffered two gunshot wounds Thursday night after getting into a fight with two people at... More >>
1 day ago Friday, December 06 2019 Dec 6, 2019 Friday, December 06, 2019 10:53:00 AM CST December 06, 2019 in News
RICH HILL- Relatives of a missing Missouri mother say they are growing increasingly concerned after deputies found the woman's phone,... More >>
1 day ago Friday, December 06 2019 Dec 6, 2019 Friday, December 06, 2019 10:22:00 AM CST December 06, 2019 in News
COLUMBIA - The Missouri State Highway Patrol confirmed Hayden Holt, a 17-year-old from Hallsville, died in an overnight car crash... More >>
1 day ago Friday, December 06 2019 Dec 6, 2019 Friday, December 06, 2019 6:41:00 AM CST December 06, 2019 in News
Columbia, MO
Broken Clouds 40°
7pm 42°
8pm 41°
9pm 40°
10pm 40°