FDA Approves Country’s First Medicine made from Marijuana

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 effect 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 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 afterward, 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 causes 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 the usual activities of daily living.

Usually, in the first few years of life appear Lennox-Gastaut and Dravet syndromes. People affected by it can undergo devastating and repeated seizures, occasionally dozens a day. One in five patients is predictable to expire before they are 20 years old. Associated with Lennox-Gastaut are six other drugs approved to treat seizures, but none are permitted for Dravet. Synthetic medications that look like or are equal to THC are formally approved by FDA.

Schedule II and Schedule III listed drugs have therapeutic value but also the potential for misuse. Some researchers have long assumed CBD’s potential to treat destructive seizure disorders and even patients, and parents of children suffering from severe epilepsy believed so. Patients have moved to states that have legalized medical marijuana in some situations in order to have the right to use the drug. But untrustworthy or poor-quality CBD products may be available in some retail stores.

A study at the end of last year found that nearly 70 percent of CBD products sold online were mislabeled. “The most suitable way to bring marijuana-derived treatments to patients is Controlled clinical trials testing the protection and effectiveness of a drug, along with cautious review through the FDA’s drug endorsement process,” FDA Commissioner Scott Gottlieb, said in a declaration today.

In addition, the consent was used by Gottlieb to guarantee the years-long clinical development of Epidiolex as a model for bringing goods made from marijuana to the marketplace. He said, The FDA is ready to help companies that desire to chase such research programs, but they require verifying their products work and are secure with data from clinical trials. Gottlieb said, “This is a significant medical advancement”.

“But it’s also important to note that this is not an approval of marijuana or all of its components. This is the consent of one particular CBD medicine for exact use. Well-controlled clinical trials evaluating the utilization of this compound in the cure of a specific condition were its basis. Moreover, this is a purified form of CBD. To make sure that patients get the predictable benefits it’s being delivered to patients in a dependable dosage form and through a reproducible means of delivery.

This is how sound medical science is advanced. The most widespread side effects from Epidiolex noted by FDA were drowsiness, sedation and lassitude, high liver enzymes, decreased hunger, diarrhea, pimples, tiredness, malaise and weakness, sleeplessness, sleep disorder and poor quality sleep, and infections.

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