First Prescription Formulation of Cannabidiol (CBD) Approved for Lennox-Gastaut Syndrome

28 June, 2018, 11:22 | Author: Homer Porter
  • FDA approves first ever drug derived from marijuana | TheHill

The drug set to be launched in autumn in the U.S. market is for treating rare and severe forms of epilepsy - Lennox-Gastaut syndrome (LGS) and Dravet syndrome in patients aged 2 and older.

GW's CEO Justin Gover called the approval a "historic milestone" that will offer a treatment for patients suffering from two severe forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. "Recognizing that it's beneficial for medicinal use can open the doors to making that available for far more than epilepsy".

This is also the first FDA-approved drug for the treatment of Dravet syndrome.

Dravet syndrome is a rare genetic condition that appears during the first year of life, the FDA said. The trials included 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome.

Epidiolex is a strawberry syrup that has been infused with CBD, one of the active ingredients in marijuana, and can be used as a treatment for several forms of epilepsy. 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.

Currently, CBD is still a Schedule I substance, meaning it is classified as a substance that has a high potential for abuse and no medical applications.

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The FDA noted that the most common side effects from Epidiolex 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. GW Research Ltd., the London-based company who produced Epidiolex is also expecting another decision that will require reclassifying CBD and allowing other marijuana-derived medications as well as reducing limitations on marijuana-related research.

In the press announcement, FDA stated that Epidiolex must be dispensed with a patient Medication Guide that details information about the drug's uses and risks. "This is how sound medical science is advanced".

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. Indeed, the FDA has been trying to crack down on CBD producers who make claims that their products can cure diseases like cancer. Still, the FDA maintains it is willing to help companies that want to pursue such research programs in order to develop data from clinical trials that demonstrate their products work and are safe.

Industry supporters downplayed the impact of the FDA approval.

Analysts claim that the drug launched by the pharmaceutical company may garner over United States dollars 1 billion in annual sales, becoming GW's debut "blockbuster medication".

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