The Food and Drug administration recently approved the first-ever prescription only medication derived from marijuana. Epidiolex, made by GW pharmaceuticals, will be the first-ever federally-regulated medical marijuana option for the safe and effective treatment of Dravet and Lennox-Gastaut epilepsy syndromes, respectively.
Not one is getting high, and doctor’s will only be prescribing the purified liquid CBD to patients ages two and up who have only one of the two epilepsy syndromes, which also are classified as rare and severe. Both epilepsy syndromes also are known to be typically drug resistant to anti-seizure medications.
“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. And, the FDA is committed to this kind of careful scientific research and drug development,” said FDA Commissioner Scott Gottlieb, M.D. in the FDA’s statement.
GW Pharmaceuticals, the company responsible for the development and manufacturing of Epidiolex, has both US- and UK-based operations. The company also is behind the first cannabis-derived medication not yet approved in the United States for the treatment multiple sclerosis spasticity.
Before earning its FDA seal of approval, though, Epidiolex had to prove its effectiveness in multiple studies that would eventually allow GW Pharmaceuticals the legal right to make statements like “reduces seizures”. Patients diagnosed with either of the two forms of epilepsy for which Epidiolex is now approved took part in multiple double-blind, placebo-controlled clinical trials. Results showed that when compared to a placebo and when taken with other prescribed medications, Epidiolex did, in fact, reduce seizure frequency.
Billy Dunn, M.D. and director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research also addressed a special significance of the Epidiolex approval above and beyond which plant its extracted from, in the same statement.
“The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients’ quality of life,” said Dunn, “In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition.”
As with every prescription medication, patients and caregivers taking or administering Epidiolex should be aware of common side effects, which can include elevated liver enzymes, feelings of sedation, sleepiness, insomnia, and infections. Patients and patient families also should be aware that Epidiolex will be dispensed with a patient Medication Guide spelling out its uses and risks. Epidiolex does, in fact, come with a significant number of risks, such as a potential increase of suicidal feelings and thoughts, or attempts to initiate a plan to die by suicide, depression (new or worsening), vomiting, and fatigue among them. Families should also know that this is true across the board for every anti-seizure drug available.
CBD does not cause the “high” commonly associated with the entire marijuana plant. It’s the tetrahydrocannabinol (THC), the FDA says, that is primarily responsible for marijuana’s psychoactive component. Rather, unregulated CBD sold at vape shops, natural food stores, and online, has been (and still is) commonly used by many wishing to avoid or reduce dependence on prescription medications to address a number of mental and physical health conditions, including anxiety, insomnia, PTSD, arthritis, depression, chronic pain, and nausea.
“CBD may eventually offer even more regulated options for treating chronic pain, inflammation, and more,” Harvard Health Publishing Contributing Editor Dr. Peter Grinspoon explained in his recent article discussing the FDA’s approval of Epidiolex and the importance of recent study findings confirming an average reduction in seizures experienced. Grinspoon suggests that anyone who believes they may benefit from CBD supplementation should also do their homework on any brands they may be considering regarding quality. He also said that patients should ask a healthcare professional about potential side effects and interactions with the other medications they are taking.
“While CBD has great therapeutic potential, and while more evidence is coming out about its efficacy and safety practically on a daily basis, CBD is still largely available as a supplement (unless you have a certification for cannabis and live in a state where medical cannabis is legal),” Grinspoon said. “Patients need to be careful about the quality of the product and the accuracy of the dosing, and should talk to their doctor (assuming their doctor is educated about this) about potential side effects and interactions with the other medications they are taking.”
For those with either Lennox-Gastaut or Dravet epilepsy syndromes who now have the option of choosing between a CBD supplement online and talking to their doctor to ask about prescribed Epidiolex, Dr. M. Scott Perry, Medical Director, Neurology; Co-Director of the Jane and John Justin Neurosciences Center; Medical Director, Tuberous Sclerosis Complex Clinic, believes the answer is clear.
“From my standpoint the answer is pretty easy right out of the gate. I feel much better about the drug that I know is regulated to monitor the efficacy, safety, and purity than I feel about buying at a dispensary or online, both of which only have unregulated, supplemental CBD,” Perry said. “You don’t know what you’re getting”.”
Thanks to Epidiolex, says Perry, families now have one more option to treat their child’s epilepsy.
Learn more about CBD and seizures.
Video Source: The Realm of Caring
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