January 22, 2019

FDA Approves The First Marijuana-Derived Drug For Childhood Epilepsy

26 June 2018, 03:27 | Randall Craig

FDA approves first cannabis-based drug

The Food and Drug Administration approved the medication from GW Pharmaceuticals on Monday to treat two rare forms of childhood epilepsy

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.

US health regulators have approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law.

Two months after a unanimous recommendation by an outside group of FDA experts and some glowing recommendations in the internal review, GW will now set out to open up a new class of meds after demonstrating the drug's ability to prevent seizures in children suffering from rare cases of Lennox-Gastaut syndrome and Dravet syndrome.

Patients with Lennox-Gastaut and Dravet syndromes, which typically emerge in the first few years of life, can suffer from debilitating and recurrent seizures, sometimes dozens a day.

GW Pharma grows its own supply of cannabis in specialized glass houses in the United Kingdom to ensure uniformity in the genetic composition of the plants, which are then processed into a liquid solution of CBD.

In 1985, the FDA signed off on Marinol, which contains a synthetic version of THC, to treat loss of appetite in people with AIDS. "And the FDA is committed to this kind of careful scientific research and drug development", Gottlieb concluded.

In company-sponsored clinical studies, cannabidiol reduced the frequency of patients' seizures.

"For those living with intractable seizures caused by LGS and Dravet syndrome, Epidiolex represents a true medical advancement", said Philip Gattone, president and CEO of the Epilepsy Foundation.

"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", Gover said.

Ohio's medical marijuana program was expected to be operational in early September but now has no definite start date, and none of the approved cultivation centers has begun growing the plant.

Epidiolex would also be the first approved therapy for DS, treatments for which are now limited to a combination of seizure medication and drugs to prevent emergencies.

Side effects with the drug include diarrhea, vomiting, fatigue and sleep problems.

"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" said FDA Commissioner Scott Gottlieb. "There's no time line or clock that starts ticking on us". Until now, the Drug Enforcement Administration has classified CBD as a Schedule 1 substance.

Shauna Garris, a pharmacist, pharmacy clinical specialist and adjunct assistant professor at the University of North Carolina's Eshelman School of Pharmacy, said the drug is effective and works somewhere between "fairly" and "very well". A study at the end of previous year found that almost 70 percent of CBD products sold online were mislabeled.

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