Last week the FDA approved studies of CBD, a cannabis-based drug.
In order to reap the health benefits of marijuana without getting the “high” from the plant’s psychoactive ingredient, many medical marijuana patients have turned to a variety of the plant that is so low in THC that it is nearly impossible to get high. Instead, the plant is high in another ingredient — cannabidiol, or CBD, which has been anecdotally proven to help those who suffer from seizures.
Since marijuana is classified as a Schedule I drug, its medicinal use remains illegal. But that may soon be changing. Last week the U.S. Food and Drug Administration announced it would allow Investigational New Drug, (IND) studies of CBD as an anti-seizure medication.
According to a report from the medical marijuana journal O’Shaughnessy Online, the “new drug” being tested is a cannabis-based drug made by the British company GW Pharmaceuticals, called Epidiolex. The drug is a THC-free liquid medicine that contains more than 98 percent CBD along with trace amounts of other cannabinoids.
The CBD-seizure study will be conducted by doctors at New York University and the University of California-San Francisco, and will each involve 25 persons with epilepsy.
“In the coming months, if the FDA is comfortable about how things are going, there will be a number of senior epileptologists in major university centers throughout the U.S., each treating a couple of dozen patients with various epilepsies,” said GW Pharmaceuticals’ Chairman Dr. Geoffrey Guy.
“Our definition of pure,” says Guy, “is no THC.” He added that the company will provide two strengths to the physician-investigators: 25 milligrams per milliliter, and 100mg/ml.
Since there are many people turning to CBD-heavy strands of medical marijuana to help treat symptoms of epilepsy, hundreds of people, especially parents of children who suffer from a form of epilepsy, have expressed interest in participating in the trial.
As many medical marijuana advocates point out, cannabis has been “used since biblical times” to treat a variety of medical conditions including epilepsy. Though CBD has been known to have anti-seizure properties, legalization advocates say use of the drug has been banned as part of the U.S.’ War on Drugs, which has likely contributed to the early deaths of tens of thousands of people.
Guy said that each study will be able to enroll additional patients so long as the FDA approves the increase.
If the study has positive results, it’s not clear whether or not the FDA and Drug Enforcement Administration will allow Americans to obtain a prescription for CBD. Some say that just like the federal medical marijuana program, known as the Compassionate Use Investigational New Drug Program, only a handful of Americans will be allowed to use the drug under federal law.
Earlier this year, Allen St. Pierre, executive director of the National Organization for the Reform of Marijuana Laws, told Mint Press News he finds it confusing that the head of the DEA, Michele Leonhart, said that there was no medicinal benefit to using marijuana, all while the federal government provides marijuana to the patients in the IND program.
If marijuana is toxic, St. Pierre said, it’s unethical for the government to continue giving it to these patients. “So what is it,” he said he’d ask the federal government, “are you unethical or are you lying?”
Betty Aldworth, deputy director for the National Cannabis Industry Association, agreed and said the program is an example of the government ignoring its own science, since the National Institute of Health recognizes medicinal benefits of marijuana.
Cannabis’ Big Pharma developer
GW Pharmaceuticals has been developing cannabis-based plant extracts since 1998.
The pharmaceutical company has another cannabis-based product, a spray called Sativex — a 50/50 THC/CBD solution — which has been approved for use in more than 20 countries to treat multiple sclerosis symptoms.
Since 2012, American parents have reportedly been contacting GW Pharmaceuticals in the hope that they would be able to obtain CBD to treat their children. By that time the company had already conducted five-and-a-half years worth of studies on the safety of CBD, and was able to provide the FDA with information such as the chemistry, manufacturing, controls, pharmacology, and toxicology reports of the drug they wanted to market.
As part of the new study, doctors in the U.S. can contact GW’s associate medical director and see if their patient can be admitted to a study. But as O’Shaughnessy Online reported, before a person can be accepted into the trail, the manufacturer must confirm the doctor’s expertise and ensure that the patient will be “properly selected and monitored.”
“If the would-be investigator has an affiliation with a medical center, he or she would have to get the approval of an Institutional Review. Then s/he would need to get DEA and the corresponding state agency to license their ‘site’ [office] for dispensing of Epidiolex. They would also need to get an import license.”
As MPN previously reported, marijuana strains high in CBD are being used to treat all sorts of medical conditions, including cancer, autism and attention deficit hyperactivity disorder. Even though marijuana is banned under federal law, NORML says a majority of scientific studies on the plant back up the miraculous claims made by the parents of pediatric medical marijuana patients.
Varying strains of marijuana have different levels of THC, the main active ingredient in marijuana, and as a result have different effects. For example, some strains are good for nighttime use because they make the user sleepy, while others are good for daytime use because they keep the user alert and awake.
When asked why GW Pharmaceuticals had not publicized its findings back in January that CBD was rated favorably among patients for treating seizures, Guy said that GW Pharmaceuticals is “in the business of developing medicines, not headlines. If we had made a big splash about the initial findings, someone in the scientific community would ask, ‘What have you got?’ And we’d say, ‘Well, we’ve got one or two children.’ That wouldn’t be enough evidence to impress them.
“We wanted to make sure that the pediatric epileptologists were comfortable with the approach being taken and that the FDA would go with it. We’ve been very busy in the U.S. this past year, but we’ve kept our heads down. In the months ahead you’ll see a manifestation of all that work. Then it’s a matter over the next year or two of generating sufficient data of appropriate quality and scope to be able to move towards getting approval.”
Guy added that he expects the IND studies to generate “understanding and experience in what [CBD] does in these different children groups, what benefit we can see, and how the results can best be measured.”
According to Guy, CBD is exerting “not just an anti-seizure effect.”
“It’s anti-inflammatory, neuro-modulatory, and has been shown in animals to counter neonatal hypoxic ischemia [oxygen starvation during delivery] —an important problem you see after seizures in these children. You’ve got an underlying inflammatory process which is massively exaggerated by excitotoxicity after each seizure, which is setting up the next seizure in a way.”
“It’s not enough to treat just the seizures without treating the underlying inflammatory encephalitis and the hypoxic ischemia and the damage to neuroplasticity. Children’s brains are very plastic and can usually work around issues, but if you’re having continuing seizures and continuing inflammation, that ability will be dampened. We’re hoping from the preclinical work that [CBD] will address a number of these different issues, not just one.”
Part of the excitement with the study is that for children like Jayden David — who previously was taking 22 anti-seizure pills a day — CBD doesn’t appear to damage cognition or long-term development of a child.
In an interview with MPN earlier this year, Jayden’s father Jason said that some of the pills Jayden was taking had withdrawal symptoms that are worse than heroin. Jason said that he was at his wits’ end, so he decided to try medical marijuana for his son. He obtained a variety that was high in CBD and says the first day Jayden tried CBD was the first day he went seizure-free in four-and-a-half years.
“Before, Jayden couldn’t go into a swimming pool,” he said, explaining that his seizures were triggered by excitement, reflective objects, hot and cold temperatures. But not only can Jayden go swimming now, he can get in the car by himself, climb on the playground, go up on the slide, and chew his food.
“Up until he was 5 years old everything had to be pureed,” David said. Jayden is also able to walk “a hundred times better,” he said.