FDA Approves Marketing Of Plant-Derived Marijuana Medicine

DISTRICT OF COLUMBIA:  Regulators at the US Food and Drug Administration on Monday granted market approval to Epidiolex, a prescription medicine containing a standardized formulation of plant-derived cannabidiol (CBD) for the explicit treatment of two rare forms of severe epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.

The proprietary extract formulation – developed by the British biotechnology firm GW Pharmaceuticals – had demonstrated safety and clinical efficacy at reducing seizure frequency in several placebo-controlled trials. It is the fourth marijuana-based medicine to receive US FDA approval – joining dronabinol (aka Marinol), nabilone (aka Cesamet), and liquid synthetic THC (aka Syndros). However, Epidiolex is the first FDA-approved medicine containing plant-derived, non-synthetic cannabinoids.

Commenting on the agency’s decision, NORML Deputy Director Paul Armentano said: “We anticipate that Epidiolex will be the first of many potential FDA-approved medicines based on the cannabis plant. Nonetheless, these alternatives should not be regulated as options to replace the use and regulation of herbal cannabis – a product that humans have used safely and effectively as a medicine for thousands of years and is approved today by statute in 30 states.”

Federal agencies have 90 days to determine the scheduling of Epidiolex under the US Controlled Substances Act. According to the New York Times, analysts expect Epidiolex to cost patients between $2,500 and $5,000 a month.

Despite the FDA’s approval of Epidiolex, the agency acknowledged in a statement that the cannabidinoid CBD still remains classified at this time as a schedule I controlled substance, and that the agency is “prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims.” FDA Commissioner Scott Gottlieb further added: “This is the approval of one specific CBD medication for a specific use. … [T]his is not an approval of marijuana or all of its components.”


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org.

FDA Approves First Cannabis-Based Epilepsy Drug

MARYLAND: The U.S. Food and Drug Administration has approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.

CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC). It is THC (and not CBD) that is the primary psychoactive component of marijuana.

“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. “Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”

Dravet syndrome is a rare genetic condition that appears during the first year of life with frequent fever-related seizures (febrile seizures). Later, other types of seizures typically arise, including myoclonic seizures (involuntary muscle spasms). Additionally, status epilepticus, a potentially life-threatening state of continuous seizure activity requiring emergency medical care, may occur. Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others.

Lennox-Gastaut syndrome begins in childhood. It is characterized by multiple types of seizures. People with Lennox-Gastaut syndrome begin having frequent seizures in early childhood, usually between ages 3 and 5. More than three-quarters of affected individuals have tonic seizures, which cause the muscles to contract uncontrollably. Almost all children with Lennox-Gastaut syndrome develop learning problems and intellectual disability. Many also have delayed development of motor skills such as sitting and crawling. Most people with Lennox-Gastaut syndrome require help with usual activities of daily living.

“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 Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “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.”

Study: CBD Extracts Significantly Reduced Seizure Frequency In Children With Refractory Epilepsy

ISRAEL: The adjunctive use of CBD extracts is safe and effective in adolescent patients with refractory epilepsy, according to clinical data published online ahead of print in the journal Brain & Development.

Israeli researchers assessed the sustained daily use of extracted CBD oils in a cohort of young patients with treatment resistant epilepsy.

Thirty-five percent of participants experienced a reduction in mean monthly seizure frequency of 75 percent or greater following CBD treatment. Forty-one percent of patients either partially or completely tapered their use of anti-epileptic drugs during the study period due to improvements in their condition. Patients who were younger than ten years of age at treatment onset experienced higher improvement rates compared to older subjects. The most commonly reported adverse side-effect of CBD treatment was somnolence, which was reported in 14 percent of patients.

Authors concluded, “In concordance with recent encouraging evidence, this open-label study using parental report, showed that CBD- enriched cannabis extract appears to have potential anti-seizure effect as an add- on treatment in pediatric patients with refractory epilepsy, with a favorable safety profile.”

The findings are similar to those of other recent trials reporting that the use of CBD extracts reduces seizure frequency and improves other symptoms of epilepsy. Regulators at the US Food and Drug Administration are anticipated to grant market approval this summer to a proprietary formulation of CBD oil, known as Epidiolex, for the treatment of Dravet syndrome and Lennox-Gastaut syndrome, two types of severe pediatric epilepsy.


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org. Full text of the study, “Efficacy of CBD-enriched medical cannabis for treatment of refractory epilepsy in children and adolescents – An observational, longitudinal study,” appears in Brain & Development.

Study: Artisanal CBD Preparations Associated With Reduced Seizure Activity In Epileptic Children

TENNESSEE: Cannabidiol administration is associated with a significant reduction in seizure frequency in patients with drug-resistant pediatric epilepsy, according to data published in the journal Epilepsy & Behavior.

Vanderbilt University researchers retrospectively assessed the impact of the adjunctive use of grey-market CBD products in a cohort of 108 children with refractory epilepsy.

Authors reported: “The addition of CBD resulted in 39 percent of patients having a greater than 50 percent reduction in seizures, with 10 percent becoming seizure-free. … No patients achieved CBD monotherapy, although the weaning of other antiepileptic drugs became possible in 22 percent of patients. … Increased alertness and improved verbal interactions were reported in 14 percent of patients in the CBD group.”

They concluded: “These data add additional support for the use of artisanal CBD in the treatment of drug-resistant epilepsy. … [O]utside of seizure control, CBD use was also associated with increased alertness, improved verbal communication, better social interactions, and better mood, suggesting additional benefits to use of CBD. … In summary, these findings support efficacy of artisanal CBD preparations in seizure reduction with few significant side effects.”

Phase III clinical trials have previously demonstrated the safety and efficacy of standardized, herbal CBD extracts (Epidiolex) in pediatric patients with uncontrollable seizures. Later this year, regulators at the US Food and Drug Administration will undertake a ‘priority review’ of this data to determine whether to grant Epidiolex market approval.


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org. Full text of the study, “Efficacy of artisanal preparations of cannabidiol for the treatment of epilepsy: Practical experiences of a tertiary medical center,” appear in Epilepsy & Behavior.

Report: CBD Interacts with Anti-Epileptic Drugs

New research published in Epilepsiaa journal of the International League Against Epilepsy (ILAE), suggests that an investigational neurological treatment derived from cannabis may alter the blood levels of commonly used anti-epileptic drugs. It is important for clinicians to consider such drug interactions during treatment of complex conditions.

Cannabidiol (CBD), a compound developed from the cannabis plant, is being studied as a potential anticonvulsant, and it has demonstrated effectiveness in animal models of epilepsy and in humans. An ongoing open label study (Expanded Access Program) conducted by investigators at the University of Alabama at Birmingham is testing the potential of CBD as a therapy for children and adults with difficult to control epilepsy. The study includes 39 adults and 42 children, all of whom receive CBD.

Because all of the participants are also taking other seizure drugs while they are receiving the investigational therapy, investigators checked the blood levels of their other seizure drugs to see if they changed. “With any new potential seizure medication, it is important to know if drug interactions exist and if there are labs that should be monitored while taking a specific medication,” said lead author Tyler Gaston, MD.

Dr. Gaston and her colleagues found that there were significant changes in levels of the drugs clobazam (and its active metabolite N-desmethylclobazam), topiramate, and rufinamide in both adults and children, and zonisamide and eslicarbazepine in adults only. Except for clobazam/desmethylclobazam, however, the drug levels did not change outside of the normally accepted range. In addition, adult participants in the study taking clobazam reported sedation more frequently.

Tests also showed that participants taking valproate and CBD had higher ALT and AST (liver function tests) compared with participants not taking valproate. Very high ALT and AST indicate abnormal liver function, but significant ALT and AST elevation occurred only in a mall number of participants (4 children and 1 adult), and the levels returned to normal after discontinuation of valproate and CBD.

“While the interaction between CBD and clobazam has been established in the literature, there are currently no published human data on CBD’s potential interactions with other seizure medications,” said Dr. Gaston. “However, given the open label and naturalistic follow-up design of this study, our findings will need to be confirmed under controlled conditions.”

The findings emphasize the importance of monitoring blood levels of antiepileptic drugs as well as liver function during treatment with CBD. “A perception exists that since CBD is plant based, that it is natural and safe; and while this may be mostly true, our study shows that CBD, just like other antiepileptic drugs, has interactions with other seizure drugs that patients and providers need to be aware of,” said Dr. Gaston.

 

Medical Marijuana Moves To Louisiana House

LOUISIANA: A bill that would expand medical marijuana in Louisiana cleared another hurdle here Monday, moving it one step away from final legislative passage.

Mills’ bill would expand the number of conditions that could be treated with the drug, which would be taken orally in an oil form, change the wording from “prescribe” to “recommend” to protect doctors and offer public bids to grow the crop if the LSU and Southern agcenters decline to cultivate it.Members of the House Health and Welfare Committee voted 8-6 in favor of Senate Bill 271 by Fred Mills, R-Parks, after passionate testimony for and against the measure.

Parents like Katie Corkern of Amite pleaded with the committee to support the bill, saying it was the “last hope” for her 9-year-old son Connor, who suffers from a severe form of epilepsy.

“He’s been seizing since he was 6 months old and hasn’t stopped,” said Corkern, whose voice broke with emotion. “We’ve tried 17 (legal) medications with no success and horrendous side effects. We’ve watched our friends move out of state and see their success (with medical pot). Connor has run out of options in Louisiana.”

DRUGS Landmark Study Confirms Marijuana Extract Is An Amazing Aid To Prevent Seizures In Epileptic Children

The annual meeting of the American Epilepsy Society took place in early December, where the largest study presented there confirmed the astounding benefits of medical cannabis to treat seizures.

Epilepsy affects one in 26 Americans during their lifetime, “with one-third having a form of the condition that resists treatment or effective management.” Children and young adults are particularly affected by this debilitating condition.

The findings of this study add to the growing body of evidence that cannabidiol (CBD), a non-psychoactive extract of cannabis, can provide the best option for treatment-resistant epilepsy.

Of 261 patients given CBD treatment, 45% experienced a significant reduction in seizure frequency, and 9% were seizure-free at 3 months. Some children continued to experience benefits after the trial ended, even one year after.

New Jersey Teen With Epilepsy And Autism Wins Right To Take Medical Marijuana At School

NEW JERSEY: Genny Barbour, a New Jersey teen with epilepsy and autism, will return to school full time after winning the fight to have the medical marijuana oil she needs administered to her at school, her mother tells PEOPLE. 

“We never thought that it would happen,” says Lora Barbour, Genny’s mom. “It was Governor Christie who passed this bill. We thought we would have to battle everything through the court system.” 

Last week, Governor Chris Christie signed into law a bill – inspired by Genny – that authorizes parents or primary caregivers to administer edible medical marijuana to sick or disabled children at school, while protecting school districts from liability. This means Genny, 16, will be able to go back to school full-time – she’s been going for half-days so that she can get the dosage she needs. 

The Larc School in Bellmawr , which Genny attends, officially adopted the policy on Nov. 11 and appears to be the first school in the nation to permit medical marijuana on campus, executive director Susan Weiner told NJ.com

Patients, Growers Consider Hemp Oil Law In Vermont

VERMONT: Shelly Waterman was looking for a miracle that could cure her daughter’s seizures.

Her daughter Hannah, 13, has neurological disorders. She has experienced seizures multiple times each day for most of her life. Two years ago, doctors diagnosed her with a rare and severe type of epilepsy that causes various types of seizures.

“We’ve been on five or six, maybe seven different pharmaceuticals, all in combination,” Waterman said. “None of which are able to say you are going to be seizure free.”

Hannah had gone three days without a single seizure, her mother said one afternoon in early September. Waterman of Burlington attributes this improvement to the combination of pharmaceutical drugs and a type of hemp oil from Colorado.