FDA approves CBD-based Epidiolex to treat severe forms of epilepsy
The U.S. Food and Drug Administration (FDA) has just approved the CBD-based medication Epidiolex as a treatment for two specific forms of severe epilepsy. Manufactured by GW Pharmaceuticals in London, the FDA advisory committee offered its unanimous recommendation for approval on Thursday following an additional positive review from FDA clinicians.
Despite the recent FDA approval, cannabis and related products remain on both the federal and international lists of controlled substances. However, now that the GW approval is secure, the U.S. Drug Enforcement Agency (DEA) is expected to reclassify cannabidiol- or CBD- within the next 90-days. On May 28, the agency even issued a press release stating as much.
“Today’s approval of EPIDIOLEX is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies. This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine. These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”
– CEO Justin Gover via a GW Pharmaceutical press release
Epidiolex is an oral medication approved for epileptic patients over 2-years of age suffering from Lennox-Gastaut and Dravet syndromes. The drug is designed to prevent or reduce the number, intensity, and severity of associated grand mal seizures which can often be life threatening. Epileptic seizures can also lead to physical impairments, mental and emotional disorders, learning disabilities, brain damage, and even abnormal brain development.
FDA Chief Scott Gottlieb issues statement
The estimated number of patients suffering from these two forms of severe epilepsy is about 45,000 in the United States alone. If the rollout proves even moderately successful, GW officials are hopeful that the FDA will allow Epidiolex to be prescribed for other epilepsy-related therapies.
“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies.”
– FDA Commissioner Scott Gottlieb via press release
The FDA has previously approved similar medications using synthetic THC, the layman’s term for tetrahydrocannabinol, which is the chemical compound found in cannabis believed to be provide the medicinal benefits. Many of these synthesized THC products are well-documented to provide relief from nausea in chemotherapy patients.
The newly approved Epidiolex also seems to mimic the seizure-related benefits of a hemp-based product called Charlotte’s Web which is currently sold online. The latter is a creative concoction designed in 2013 by the parents of a 6-year old epileptic child. Young Charlotte, for which the CBD product is aptly named, was able to reduce her number and severity of grand mal seizures from approximately 300 per week to only a few per month thanks to this “homemade” hemp-based remedy.
Related Article: Does vaping CBD prevent seizures in epilepsy patients?
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