FDA Approves First Marijuana-Derived Drug

The US Food and Drug Administration today approved for the first time a marijuana-derived drug, Epidiolex, for the treatment of two rare forms of epilepsy. The drug contains cannabidiol, or CBD, and does not make users high while reducing the rate of seizures in patients with Dravet or Lennox-Gastaut syndromes, clinical trials show.

“In my practice, I often see patients with these highly treatment-resistant epilepsies who have tried and failed existing therapies and are asking about CBD,” says Orrin Devinsky of NYU Langone Health, a lead investigator in the trials, in a statement released by the company that makes Epidiolex. “I am delighted that my physician colleagues and I will now have the option of a prescription cannabidiol that has undergone the rigor of controlled trials and been approved by the FDA to treat both children and adults.”

  • See “Medical Marijuana for Kids?”

Both Dravet and Lennox-Gastaut are relatively severe forms of epilepsy that can be fatal, STAT News notes. While there are other drugs approved to treat Lennox-Gastaut, there had previously been none for Dravet. Some parents have used unapproved CBD oils to treat their children. In a statement released today, FDA notes that it “has taken recent actions against companies distributing unapproved CBD products. . . . We’ll continue to take action when we see the illegal marketing of CBD-containing products with unproven medical claims.”

“I’m really happy we have a product that will be much cleaner and one that I know what it is,” Ellaine Wirrell, director of the Mayo Clinic’s program for childhood epilepsy, tells the AP. “In the artisanal products there’s often a huge variation in doses from bottle to bottle depending on where you get it.”

  • See “Opinion: Do Not Believe the Hype”

But Heather Jackson of Realm of Caring, a charity affiliated with the CBD company CW Hemp, tells the outlet, “I don’t know a mom or dad in their right mind who is going to change what’s already working. . . . I really don’t think [the FDA approval is] going to affect us much.”

Resourse: The Scientist

Kerfuffle Over Marijuana Claim

Marijuana law reform has been in the air lately. Last November, Colorado and Washington voted to legalize recreational weed use in their states, and Illinois recently became the latest state to legalize the drug for use as a medicine.

In a speech at the American Bar Association’s annual meeting this month, US Attorney General Eric Holder announced that the federal government would no longer seek harsh mandatory minimum sentences for drug offenders that had no ties to gangs, violence, or trafficking—though he drew the ire of medical marijuana proponents for failing to mention the drug specifically once during the speech. Now, the National Institute on Drug Abuse (NIDA) has weighed in on what appears to be a rising tide of pro-marijuana sentiment.

According to the CDC, more than 41,000 deaths were tied to alcohol in 2010 (almost 16,000 attributed to alcoholic liver disease and more than 25,000 to alcohol-related accidents and homicides), while zero were reportedly linked to marijuana. In addition, the CDC lists “1.2 million emergency room visits and 2.7 million physician office visits due to excessive drinking” on its website, as PolitiFact pointed out Thursday (August 15).

Resourse: The Scientist

High-Free Medical Marijuana

Cannabis contains cannabidiol (CBD), which, some studies have shown, has anti-inflammatory properties, and tetrahydrocannabinol (THC) which induces a high. Tikun Olam, a company that grows marijuana in Israel, where the plant is legal for medical purposes, has developed a variant that likely contains the highest CBD to THC ratio yet. The strain, named Avidekel, contains less than one percent THC, and nearly 16 percent CBD.

“Sometimes the high is not always what they need, sometimes it is an unwanted side effect. For some of the people it’s not even pleasant.”

Tikum Olam’s head of development Zack Klein told Reuters.

Medical marijuana is currently used by around 9,000 people in Israel, who hold licenses to use the drug to treat ailments such as chronic pain, multiple sclerosis, and the unpleasant side-effects of chemotherapy. Researchers at Hebrew University are already studying the effects of Avidekel on mice, with plans to move the herb into human trials later this year. However, patients who hold licences are already able to try the drug.

Resourse: The Scientist

Medical Precautions

A major safety concern associated with medical cannabis is the possibility of medical use encouraging or transitioning into recreational use, which is associated with side effects that range from acute to chronic. Acute effects include intoxication, impaired cognition and motor function, elevated heart rate, anxiety, and psychosis in predisposed individuals. Chronic effects include bronchitis (from smoked cannabis), psychological cannabis dependency, loss of motivation, and cognitive deficits. By and large these effects seem to disappear on abstinence.

Medical cannabis may be riskier and perhaps contraindicated if a patient has a personal or family history of psychosis, unstable cardiac disease, and lung disease. Medical cannabis users are advised by physicians not to use tobacco, either alone or mixed with cannabis. They also are advised not to drive or operate machinery while initiating or changing doses and if impaired by the drug. Apart from possible synergistic effects of cannabis with other psychotropic medications, such as sedatives and hypnotics, there are no known major drug-drug interactions.

Resourse: Britannica