US OKs marijuana-based drug for rare childhood epilepsies

Faith Castro
June 28, 2018

"Lennox-Gastaut Syndrome is a devastating form of epilepsy, and despite now available FDA-approved medications and a poly-therapy approach to treatment, the majority of individuals with LGS will continue to have life-long, debilitating seizures, along with cognitive impairment and an abnormal brain waves on EEG (electroencephalogram)".

Earlier, the agency has approved the synthetic versions of certain CBD chemicals which were found in marijuana plant for other use. This lack of regulation has led to wide variation in content, safety, and pricing of products that contain either CBD, THC, or both.

Gottlieb stresses that clinical trials that are careful and being controlled, combined with the FDA's strict process of drug approval as the best way to deliver marijuana treatments to the public.

The effects of Epidiolex could very well be a boon to patients with the two forms of epilepsy mentioned above. "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 Schedule I classification deems the drug of high risk and minimal benefit, particularly for medical use.

He said, "Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases".

Some adults with Angelman experience a type of myoclonic activity - involuntary muscle spams - that is not formally considered a seizure, but can cause debilitating tremors and muscle contractions, Bichell said. Many also have delayed development of motor skills such as sitting and crawling. Patients with these conditions often require significant assistance with daily living.

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Epidiolex had previously received Fast Track Designation and Orphan Drug Status from the FDA.

The drug was used in clinical trials and showed positive results in seizure prevention by around 40% in patients suffering with either Dravet or Lennox-Gastaut epileptic syndromes. The new drug is anticipated to become available to patients later this fall.

In the 2017 Legislative Session state lawmakers approved the use of CBD Oil, without FDA approval, to treat illnesses such as childhood epilepsy and PTSD in veterans.

Epidiolex won't be causing psychoactive effects comparable to marijuana. It comes from a proprietary strain of cannabis grown by GW that has been bred to have high levels of CBD and low levels of tetrahydrocannabinol (THC), the cannabis constituent that produces the euphoric high typically associated with marijuana and cannabis-derived products. The company has pushed legislation in several states to make sure its drug can be legally sold and prescribed. Until now, the Drug Enforcement Administration has classified CBD as a Schedule 1 substance. The FDA granted "Priority Review" designation for GW's application. FDA also granted fast-track designation for Epidiolex for Dravet syndrome.

FDA officials said the drug reduced seizures when combined with older epilepsy drugs.

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