FDA Approves Country’s First Medicine made from Marijuana

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The country’s first drug derived from marijuana, a medicine that treats two uncommon and destructive forms of epilepsy has been approved by the Food and Drug Administration. The country’s first marijuana-based prescription medication was announced on Monday June 25 by the US Food and Drug Administration.

Epidiolex is a plant derivative, oral suspension of cannabidiol (CBD)—a chemical constituent of marijuana that does not cause intoxication or ecstatic “high.” Patients aged two and grown-up who undergo unusual and severe forms of epilepsies known as Lennox-Gastaut syndrome and Dravet syndrome are treated by this drug, which can develop early in infancy. Epidiolex’s authorization also marks the foremost time the FDA has permitted a drug to treat Dravet syndrome.

Food and Drug Administration Commissioner Scott Gottlieb said “This consent serves as a cue that advancing sound development programs that appropriately assess active ingredients contained in marijuana can lead to significant medical therapies,”. Cannabidiol (CBD) is the building block of the drug Epidiolex, one of the hundreds of molecules found in the marijuana plant, and contains less than 0.1 percent of tetrahydrocannabinol (THC), the psychoactive constituent that makes people feel elevated.

The patients with Dravet syndrome and Lennox-Gastaut syndrome practice “The difficult-to-control seizures that have an intense affect 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 assessment and Research. People with both syndromes suffer frequent, different types of seizures and typically experience developmental difficulties including poor development of motor skills and intellectual disability and Epidiolex represents the first FDA-approved treatment for Dravet syndrome.

Dravet syndrome appears during the first year of life with recurrent (febrile seizures) fever-related seizures and it is an unusual genetic disease. Other types of seizures characteristically occur afterwards, including myoclonic seizures (spontaneous muscle spasms). Additionally, status epilepticus, a potentially life-threatening state of continuous seizure activity requiring emergency medical care, may occur.

Poor development of language and motor skills are typically experienced by Children with Dravet syndrome, hyperactivity and trouble involving others. Lennox-Gastaut syndrome begins in childhood. It is characterized by multiple types of seizures. Patients suffering from Lennox-Gastaut syndrome begin having recurrent seizures in early infancy, generally between ages 3 and 5.

Tonic seizures affect more than three-quarters of individuals, which cause the muscles to contract wildly. Almost all children with Lennox-Gastaut syndrome develop learning problems and intellectual disability. Belated development of motor skills for instance sitting and crawling occurs in many patients. Most people with Lennox-Gastaut syndrome require help with usual activities of daily living.

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Gottlieb implicit at supplementary enforcement trial against companies that trade unfettered CBD products with medical claims that aren’t backed up by confirmation, the FDA has formerly sent admonition letters to companies that overvalued their products as cancer or Alzheimer’s fighters. “Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases,” he said.

Reference:

  • FDA approves country’s first medicine made from marijuana By ANDREW JOSEPH via Stat News
  • Marijuana drug wins FDA approval—a first that may change federal regulations by Beth Mole via Ars Technica

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