FDA FINALLY Approves Cannabis-Based Epilepsy Drug
After years of tests and clinical trials, the U.S. Food and Drug Administration (FDA) finally approved the first cannabis-based drug on June 25, 2018, to treat rare and severe forms of epilepsy. [1]
In a statement, FDA Commissioner Scott Gottlieb said the drug’s approval should not be considered approval of marijuana in general, and that anyone wanting to use marijuana-based products to treat disease must first prove they are safe and effective.
The drug, Epidiolex, is a formulation of cannabidiol (CBD), a marijuana cannabinoid that does not contain THC and therefore does not make users high. CBD is currently exploding in popularity due to its ability to ease pain, reduce anxiety and depression, and – most famously – reduce epileptic seizures.
The FDA’s Dr. Billy Dunn said:
“The difficult-to-control seizures that patients with a Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients’ quality of life.
In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition.”
The Dravet Syndrome Foundation explains on its website that “Dravet syndrome is a rare, catastrophic, lifelong form of epilepsy that begins in the first year of life with frequent and/or prolonged seizures.” It affects literally every aspect of a person’s life. [2]
According to the website, common issues associated with the syndrome include:
- Prolonged seizures
- Frequent seizures
- Behavioral and developmental delays
- Movement and balance issues
- Orthopedic conditions
- Delayed language and speech issues
- Growth and nutrition issues
- Sleeping difficulties
- Chronic infections
- Sensory integration disorders
- Disruptions of the autonomic nervous system (which regulates things such as body temperature and sweating)
Those with Dravet have a 15% to 20% mortality rate due to Sudden Unexpected Death in Epilepsy (SUDEP), prolonged seizures, and seizure-related accidents such as drowning and infections.
On its website, the Epilepsy Foundation explains that Lennox-Gastaut is a disorder that causes multiple types of seizures and, in some cases, delayed intellectual development. [3]
People with Lennox-Gastaut show “a classic pattern of background-slowing and spike-wave bursts at frequencies less than 2.5 seconds.” It develops during childhood and typically continues into adulthood. In 1 out of 4 children with Lennox-Gastaut, the cause is unknown.
The FDA only approved the liquid formulation of Epidiolex for Dravet and Lennox-Gastaut. [1]
Gottlieb stressed that other cannabis-based drugs have yet to make the cut.
“This is an important medical advance. But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use.
This is a purified form of CBD. It’s being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits.”
There are numerous cannabis products on the market that purport to treat everything from cancer to anxiety, but those claims are unproven, and the FDA has been going after those companies and warning the public to beware of the products.
Gottlieb added:
“The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”
The maker of Epidiolex, GW Pharmaceuticals, studied the drug in more than 500 children and adults with difficult-to-treat seizures, successfully leaping over legal and regulatory hurdles along the way. [4]
We should point out marijuana is backed by more studies than most FDA-approved pharmaceutical drugs, many of which are only supported by 1 clinical trial.
Sources:
[1] NBC News
[2] Dravet Syndrome Foundation
[4] CBS News
