A 13-member FDA advisory committee unanimously voted to fully recommend approval for a drug known as Epidiolex, which will be the first prescription cannabidiol medicine of its kind to ever receive such an accepting approval. The drug would be used to treat rare and severe forms of epilepsy but will be limited to treating seizures caused by Lennox-Gastaut syndrome and Dravet syndrome in patients 2 and older.
Philip Gattone, President & CEO of the Epilepsy Foundation stated…” Epidiolex represents hope for the many individuals living with intractable seizures and rare epilepsies, who everyday face incredible challenges and disabling seizures, and live with the continual risk of serious injury and death.” Dravet syndrome is a very rare and often deadly form of epilepsy cause by a genetic mutation within the body. Children with this affliction have multiple and prolonged seizures that cause brain damage. Lennox-Gastaut syndrome, also rare, causes various seizures and severe cognitive impairment.
Epidiolex is the idea of a British company, GW Pharmaceuticals, which has gone through all the required testing deemed necessary to even be considered for FDA approval. Many other products have made their way onto the internet making various CBD cure claims but most of those claims have not been found to be effective; which had caused the FDA to issue warnings to those companies for making such unsubstantiated claims. Epidiolex has been able to hold water to its claims.
Epidiolex isn’t something that would be available in a dispensary in the US and you would not be able to get these properties from smoking the flower directly, this is a very precise pharmaceutical grade product coming from the cannabis plant. Epidiolex is a syrup-based oral medication and will be manufactured under guidelines known as good manufacturing practices, so that patients can be assured that they are getting what is supposed to be in the bottle. Dr. Orrin Devinsky, director of NYU Langone Epilepsy Center said…” It’s incredibly important as a physician prescribing to patients that we know what we’re giving them and we know we give them one month will be the same that we give them three or six months later.”
Its agreed by many that cannabis needs more testing but doctors are still interested in also trying CBD to treat other disorders like autism, anxiety, inflammatory and autoimmune deficiencies.
Advocates for the development of cannabis-based treatments were very happy with the FDA recommendation. “This is a very good development, and it basically underscores that there are medicinal properties to some of the cannabinoids,” said Dr. Igor Grant, director of the Center for Medicinal Cannabis Research at the University of California San Diego. “I think there could well be other cannabinoids that are of therapeutic use, but there is just not enough research on them to say.”
By Tracy Jerome Chisley (@PoeticPanther)
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