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Posted by: thepinetree on 06/26/2018 08:20 AM Updated by: thepinetree on 06/26/2018 08:20 AM
Expires: 01/01/2023 12:00 AM
:

FDA Approves First Drug Comprised of an Active Ingredient Derived from Marijuana

Washington, DC...The U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.




CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC).

It is THC (and not CBD) that is the primary psychoactive component of marijuana.

“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development,” said FDA Commissioner Scott Gottlieb, M.D. “Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. 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 that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”

Dravet syndrome is a rare genetic condition that appears during the first year of life with frequent fever-related seizures (febrile seizures). Later, other types of seizures typically arise, including myoclonic seizures (involuntary muscle spasms). Additionally, status epilepticus, a potentially life-threatening state of continuous seizure activity requiring emergency medical care, may occur. Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others.

Lennox-Gastaut syndrome begins in childhood. It is characterized by multiple types of seizures. People with Lennox-Gastaut syndrome begin having frequent seizures in early childhood, usually between ages 3 and 5. More than three-quarters of affected individuals have tonic seizures, which cause the muscles to contract uncontrollably. Almost all children with Lennox-Gastaut syndrome develop learning problems and intellectual disability. Many also have delayed development of motor skills such as sitting and crawling. Most people with Lennox-Gastaut syndrome require help with usual activities of daily living.

“The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients’ quality of life,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “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.”

Epidiolex’s effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome. Epidiolex, taken along with other medications, was shown to be effective in reducing the frequency of seizures when compared with placebo.

The most common side effects that occurred in Epidiolex-treated patients in the clinical trials were: sleepiness, sedation and lethargy; elevated liver enzymes; decreased appetite; diarrhea; rash; fatigue, malaise and weakness; insomnia, sleep disorder and poor quality sleep; and infections.

Epidiolex must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. As is true for all drugs that treat epilepsy, the most serious risks include thoughts about suicide, attempts to commit suicide, feelings of agitation, new or worsening depression, aggression and panic attacks. Epidiolex also caused liver injury, generally mild, but raising the possibility of rare, but more severe injury. More severe liver injury can cause nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice and/or dark urine.

Under the Controlled Substances Act (CSA), CBD is currently a Schedule I substance because it is a chemical component of the cannabis plant. In support of this application, the company conducted nonclinical and clinical studies to assess the abuse potential of CBD.

The FDA prepares and transmits, through the U.S. Department of Health and Human Services, a medical and scientific analysis of substances subject to scheduling, like CBD, and provides recommendations to the Drug Enforcement Administration (DEA) regarding controls under the CSA. DEA is required to make a scheduling determination.

The FDA granted Priority Review designation for this application. Fast-Track designation was granted for Dravet syndrome. Orphan Drug designation was granted for both the Dravet syndrome and Lennox-Gastaut syndrome indications.

The FDA granted approval of Epidiolex to GW Research Ltd.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

###


Comments - Make a comment
The comments are owned by the poster. We are not responsible for its content. We value free speech but remember this is a public forum and we hope that people would use common sense and decency. If you see an offensive comment please email us at news@thepinetree.net
No Subject
Posted on: 2018-06-26 08:32:53   By: Anonymous
 
there goes society right down the old looo. prepare for the next generations of dumbed down welfare mooching liberal drones.

[Reply ]

    Re:
    Posted on: 2018-06-26 10:00:25   By: Anonymous
     
    Speaking of dumbing down, try reading the second sentence again. This is so Calaveras, cocked and ready to respond without reading for understanding.

    [Reply ]

No Subject
Posted on: 2018-06-26 08:33:24   By: Anonymous
 
I can hear the cries of the commercial folks whining about big pharma now. How obvious. Let's face it folks, the growers first attempt at sugar-coating their lucrative kick-back "job" was that it is all about the medicine. So which is it now? Is it still about the medicine, and you are stoked for patients that the medicinal aspects of marijuana are finally getting federally recognized? Or is it time to fight against what you supposedly wanted because it means not as much easy money for YOU?

[Reply ]

    Re:
    Posted on: 2018-06-26 09:58:32   By: Anonymous
     
    So you would rather big Pharma control the market and prices as they now do for all your other prescription medications?

    [Reply ]

    Re:
    Posted on: 2018-06-26 10:42:18   By: Anonymous
     
    Are you saying that when individuals recognizes a business opportunity, they shouldn't take advantage of it? Would you rather more box stores and chain restaurants, too" Kind of flies in the face of the American way, doesn't it? No worries, Calaveras stalled so long that it'll all be big business in a year or two with no benefit to our community.

    [Reply ]

    Re:
    Posted on: 2018-06-27 08:35:25   By: Anonymous
     
    ^Its by any means a kick back job. A small personal grow can be difficult for good product, but commercially it takes up all of your time. Don't make comments or assumptions when clearly your clueless.

    [Reply ]

No Subject
Posted on: 2018-06-26 09:39:28   By: Anonymous
 
Finally kids/adults suffering all around are country can get the medicine they need without prosecution.

[Reply ]

    Re:
    Posted on: 2018-06-26 09:41:52   By: Anonymous
     
    CBD doesn't get you high idiots.

    [Reply ]

    Re:
    Posted on: 2018-06-26 09:59:13   By: Anonymous
     
    Yes. A step finally in the right direction.

    [Reply ]

No Subject
Posted on: 2018-06-26 09:43:36   By: Anonymous
 
Humans produce CBD naturally so does marijuana we're realated.

[Reply ]

    Re:
    Posted on: 2018-06-26 10:58:51   By: Anonymous
     
    Related?
    You and yours might be manure generated plants, not me.

    [Reply ]

      Re:
      Posted on: 2018-06-26 11:29:06   By: Anonymous
       
      Then you might want to take a refresher biology class and talk about cell structure.

      [Reply ]

        Re:
        Posted on: 2018-06-26 15:09:40   By: Anonymous
         
        Maybe Clapp can get some for his tremors like the ones he had during the reading of the senior abuse proclamation!!!!

        [Reply ]

          Re:
          Posted on: 2018-06-26 20:29:26   By: Anonymous
           
          ...or Hillary for killing all those baby ducks with her pia gate.

          [Reply ]

            Re:
            Posted on: 2018-06-26 20:40:39   By: Anonymous
             
            Lose any zzz's lately?

            [Reply ]

          Re:
          Posted on: 2018-06-28 21:25:36   By: Anonymous
           
          You're an idiot. Clyde Clapp is there for a reason and he was elected for a reason.

          [Reply ]


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