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Turning point for marijuana as medicine?

Epidiolex, the first FDA-approved medication made from marijuana, is now available by prescription in the United States. CNN's Dr. Sanjay Gupta reports.

Posted: Nov 2, 2018 10:38 AM
Updated: Nov 2, 2018 11:13 AM

Epidiolex, the first cannabis-based medication approved by the US Food and Drug Administration, is now available by prescription in all 50 states.

The twice-daily oral solution is approved for use in patients 2 and older to treat two types of epileptic syndromes: 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 begins in early childhood, usually between ages 3 and 5.

"Because these patients have historically not responded well to available seizure medications, there has been a dire need for new therapies that aim to reduce the frequency and impact of seizures," said Justin Gover, CEO of GW Pharmaceuticals, the maker of Epidiolex, in a written statement. "We are committed to ensuring that these patients can access this novel cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and is eligible to be covered by insurance for appropriate patients."

Epidiolex was recommended for approval by an advisory committee in April and approved by the FDA in June. In September, the US Department of Justice and the Drug Enforcement Administration classified Epidiolex as a Schedule V substance, clearing the final hurdle for it to be legally prescribed by doctors in the United States. (Marijuana and CBD remain Schedule I substances.)

"Adequate and well-controlled clinical studies supported Epidiolex's approval, so prescribers can have confidence in the drug's uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes," FDA Commissioner Dr. Scott Gottlieb said in a written statement. "The FDA will continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and stand ready to work with product developers who are interested in bringing patients safe and effective, high quality products."

Dr. Orrin Devinsky, director of the Comprehensive Epilepsy Center at NYU Langone Health, served as the lead investigator of two of three phase three clinical trials of Epidiolex.

"In those syndromes, when [Epidiolex] was added to three other seizure [medications], on average, it reduced convulsive seizures -- or 'drop seizures' -- by about 25% to 28% compared to a placebo," Devinsky said. "So I think it's very important to recognize ... that it clearly is effective, and this was statistically significant in all three of the large studies that we did, but by the same token, the effect was modest.

"There are some people who had dramatic improvements. Many had a modest improvement, and some had no improvement. So it's not a miracle drug. It's an effective drug, and I think its side effect profile is quite good compared to other seizure drugs that we have, but it's not a miracle cure," Devinsky said.

The most common side effects of Epidiolex, according to GW Pharmaceuticals, include sleepiness, decreased appetite, diarrhea and an increase in liver enzymes.

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.

Still, she said the FDA's approval of Epidiolex signals "validation of the science of cannabinoid medication."

GW Pharmaceuticals says the average list price of Epidiolex is $32,500 a year. The company expects that the drug will be covered by most insurance plans and asserts that "this price is in line with other branded, FDA-approved anti-epileptic drugs (AEDs), such as Banzel, and access for eligible patients is expected to be similar to such AEDs for similar indications for LGS (e.g., Onfi and Banzel)."

It is also launching a patient support program "to help patients who have been prescribed Epidiolex gain access to therapy. The program offers patient/caregiver-focused education and resources to help lower out-of-pocket costs or provide product at no cost for eligible patients."

Although Epidiolex is approved only for the treatment of two rare seizure disorders, doctors can now prescribe the medication "off-label" for other conditions. According to the US Department of Health and Human Services, this is both legal and common; one in five of all medications prescribed is for off-label use.

"The off-label use of CBD and Epidiolex will be a fascinating subject to look at over the coming years," Devinsky said. "Many, many patients would like to have access to it who don't fit the criteria, and I believe many doctors will try to prescribe it, as will I for some people who I think have tried many, many medications and for whom it might be beneficial."

He added, "I think doctors are always trying to make those decisions about a good benefit-to-toxicity ratio, and CBD is a fairly attractive compound. The question is, what will the insurance companies do?"

Mississippi Coronavirus Cases

Data is updated nightly.

Cases: 266598

Reported Deaths: 5852
CountyCasesDeaths
DeSoto17807191
Hinds16967332
Harrison14298204
Rankin11280221
Jackson10976190
Lee9088145
Madison8619169
Jones6782118
Forrest6236124
Lauderdale6128192
Lowndes5564120
Lafayette5229101
Lamar507465
Washington4951125
Bolivar4149109
Oktibbeha409482
Panola388281
Pontotoc378560
Warren3698103
Monroe3693110
Marshall358570
Union357764
Pearl River3508106
Neshoba3499154
Leflore3122109
Lincoln307688
Hancock296362
Sunflower293075
Tate281162
Alcorn273554
Pike271081
Itawamba270063
Scott260849
Yazoo257156
Prentiss254554
Coahoma251555
Copiah250749
Tippah250150
Simpson243872
Leake238467
Marion225973
Grenada224272
Covington222473
Adams215371
Wayne215034
Winston207771
George204839
Newton200046
Attala197464
Tishomingo195661
Chickasaw189644
Jasper182538
Holmes172268
Clay167537
Tallahatchie157535
Stone152925
Clarke148662
Calhoun141822
Smith130726
Yalobusha123835
Walthall115037
Greene114529
Noxubee114126
Montgomery112736
Lawrence107617
Carroll106922
Perry105331
Amite102426
Webster97424
Claiborne89725
Tunica89321
Jefferson Davis88930
Benton86523
Humphreys84824
Kemper81020
Quitman7149
Franklin70717
Choctaw63813
Wilkinson59925
Jefferson57121
Sharkey45717
Issaquena1606
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Alabama Coronavirus Cases

Cases: 443009

Reported Deaths: 6662
CountyCasesDeaths
Jefferson649101007
Mobile31746574
Madison28413217
Tuscaloosa21566275
Montgomery20088332
Shelby19452132
Baldwin17333189
Lee13261107
Morgan12678142
Etowah12141181
Calhoun11555206
Marshall10487123
Houston9031164
Limestone838181
Cullman8296124
Elmore8243110
Lauderdale7946107
DeKalb7900107
St. Clair7876130
Talladega6523112
Walker6050183
Jackson603245
Colbert558194
Blount548586
Autauga540762
Coffee466964
Dale412785
Franklin377550
Russell358415
Chilton346873
Covington340880
Escambia339244
Tallapoosa3163109
Dallas313696
Chambers305470
Clarke303336
Pike265231
Lawrence255855
Marion254661
Winston234742
Bibb222948
Geneva213047
Marengo210531
Pickens200431
Hale186144
Barbour183438
Fayette178829
Butler174860
Cherokee166031
Henry160025
Monroe152621
Randolph146636
Washington142727
Clay130746
Crenshaw124845
Macon122837
Cleburne122125
Lamar120622
Lowndes116836
Wilcox108322
Bullock104628
Perry100518
Conecuh98022
Sumter90627
Greene77923
Coosa64018
Choctaw52124
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