Published: Thu, June 28, 2018
Medical | By Jackie Banks

Approves first marijuana plant-derived drug

Approves first marijuana plant-derived drug

A cannabis-derived medicine has been approved for the first time by the US Food and Drug Administration (FDA).

According to the FDA, Epidiolex was shown to be effective in reducing the frequency of seizures in patients with Dravet or Lennox-Gastaut syndromes.

GW Pharma has to wait to sell Epidiolex until the Drug Enforcement Administration decides what restrictions to place on the drug to ensure that it reaches only the patients for whom it is intended.

Beyond the USA, the medicine is now under review by the European Medicines Agency for the treatment of seizures in patients with Lennox-Gastaut or Dravet syndrome.

The prescription formulation of Epidiolex is a highly purified cannabidiol (CBD) derived from the marijuana plant but lacking the psychoactive ingredient most people associate with marijuana.

The FDA's action also may bring hope to patients with other rare diseases marked by seizures, like Angelman syndrome.

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In a study involving children with Dravet syndrome, five percent became seizure free while taking the drug compared to none in the placebo arm, and patients also had a significantly greater median reduction in convulsive seizures (39 percent) compared to placebo (13 percent). In the preparation includes purified form of the chemical ingredient that contain in marijuana - cannabidiol.

"It's nice to have that the government hopefully will allow further research into CBD for not only epilepsy, but for a variety of other conditions".

FDA officials said the drug reduced seizures when combined with older epilepsy drugs. What's more likely is that the DEA reschedules CBD, while leaving THC and marijuana itself as a Schedule 1 substance. These side effects are "sleepiness, sedation and lethargy; elevated liver enzymes; decreased appetite; diarrhea; rash; fatigue, malaise and weakness; insomnia, sleep disorder and poor quality sleep; and infections". "And the FDA is committed to this kind of careful scientific research and drug development", Gottlieb concluded. In April, the drug received unanimous approval from an FDA advisory committee, but the final decision came on Monday, June 25th. However, Epidiolex does not contain THC, the component of marijuana that gets people high, Jamie Alan, an assistant professor of pharmacology and toxicology at Michigan State University, tells Yahoo Lifestyle. The company's development program represents the only well-controlled clinical evaluation of a cannabinoid medication for patients with LGS and Dravet Syndrome.

In the press release, FDA Commissioner Scott Gottlieb, M.D appeared to indicate an open willingness to explore the medical benefits of cannabis. FDA has determined that CBD has negligible abuse potential.

This drug is also likely to be available made in the United Kingdom and Europe market from mid of 2019, though overtly subject to regulatory approval from European Medicines Agency in early next year.

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