The U.S. Food and Drug Administration has approved the prescription of a cannabis-based medicine to treat seizures. According to NBC News, the FDA approved the prescription Epidiolex, a cannabidiol medicine, on Monday, June 25. The medication will help treat severe and rare forms of epilepsy.
Epidiolex is a form of cannabidiol, or CBD, which is a strain of cannabis that doesn’t contain THC. THC (tetrahydrocannabinol) is the common cannabinoid in marijuana that produces a euphoric effect.
CBDs, such as CBD hemp oil products, contain less than 0.3% THC and therefore aren’t Fclassified as marijuana and can’t cause a euphoric effect. Strains of cannabis without THC have been found to reduce inflammation, anxiety, pain, and seizures.
The FDA approval only covers the use of Epidiolex, a liquid medication, to patients with Lennox-Gastaut Syndrome and Dravet Syndrome. Lennox-Gastaut and Dravet syndrome are two severe forms of epilepsy that begin for patients in childhood.
“The … seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients’ quality of life,” said Dr. Billy Dunn of the FDA.
“In addition to another important treatment option for Lennox-Gastaut,” Dunn said, “this first-ever approval of a drug specifically for Dravet patients will provide a significant needed improvement in the therapeutic approach to caring for people with this condition.”
FDA Commissioner Dr. Scott Gottlieb has stressed that the approval of CBDs is by no means an approval of marijuana in all its components. The recent approval specifically for cbd oil use of Epidiolex and only for those with these forms of epilepsy.
Cannabis has been known to help with pain related to cancer treatments and inflammation according to a number of small studies. This may come as good news to the 12.4% of living American women with a lifetime risk of being diagnosed with breast cancer.
Yet cannabis for health itself isn’t a cure for cancer and doesn’t serve as a cure-all for ailments. The FDA warns against any companies who advertise it as such until claims are officially proven.
“The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal disease,” said Gottlieb.
Gottlieb says the FDA needs solid scientific studies to demonstrate whether a product is capable of providing safe and efficient treatment to the public before it reviews an application for a medication or product.
The process helps to ensure that new therapies such as cryotherapy, which exposes the body to temperatures between -100 and -140 degrees Celsius for therapeutic purposes, are safe and work.
Children who suffer from Dravet syndrome often experience poor development of motor and language skills and a difficulty relating to others. Most children with Lennox-Gastaut syndrome develop intellectual disabilities and learning complications.
Epidiolex has gone through rigorous testing and studies before it was approved by the FDA. The medication is expected to help children with Lennox-Gastaut and Dravet syndrome to perform daily activities more easily.
In the past, the FDA has also approved CBD-based medications including Marinol, which is designed to treat nausea and severe appetite loss in AIDS patients.
“As part of the approval process, Epidiolex must be rescheduled from its current Schedule I [restrictions by the Drug Enforcement Administration] before it can be made available to patients,” said Greenwich Biosciences, the U.S. subsidiary of GW Pharmaceuticals which will be distributing Epidiolex. “Rescheduling is expected to occur within 90 days.”