Epidolex

Why the FDA Approved a Drug with CBD Oil Benefits

The U.S. Food and Drug Administration (FDA) is acknowledging benefits of CBD oil. On June 25, 2018, the administration approved the use of Epidiolex for the treatment of two severe forms of epilepsy: Lennox-Gastaut and Dravet syndromes.

This ruling could open the door for a wider acknowledgement of CBD oil benefits. Many already use CBD oil for conditions like anxiety and hypertension. But will CBD get the respect it finally deserves? Read more about Epidiolex and why the approval could put CBD oil benefits in mainstream medicine.

What are Lennox-Gastaut and Dravet syndromes?

According to the Epilepsy Foundation, those with Lennox-Gastaut syndrome experience several different types of seizures. They include tonic seizures (defined by stiffening), along with atonic seizures. Up to five percent of children diagnosed with epilepsy have Lennox-Gastault syndrome. Without continued lifelong treatment, Lennox-Gastaut syndrome can be fatal.

Dravet syndrome is also a rare form of pediatric epilepsy, caused by a genetic dysfunction of the brain. Signs of Dravet syndrome show in the first year of life and involve fevers followed with seizures. Grand mal and clonic seizures of two minutes or more are the most common. As children grow, they could face multipe types of seizures, triggered by light, stress or body temperature changes. While the condition may improve with time, patients need lifelong treatment and management.

What is Epidiolex?

Epidiolex (cannabidiol) is a new drug from Greenwich Biosciences. Both American and European regulators approved Epidolex for the treatment of both Lennox-Gastaut and Dravet syndromes. The medication comes from plant-based CBD without relying on synthetic sources. Patients take Epidiolex from a syringe, with exact dosage dependent on symptom severity.

Does Epidiolex offer CBD oil benefits

Using CBD oil in treating epilepsy is not a new idea. In 2014, 10 researchers presented a study on using Epidiolex to treat seizures to the American Epilepsy Society. Between their trials and anecdotal reports, they concluded cannabidiol could be an effective for treating epilepsy.

A 2015 study published in International Journal of Clinical and Experimental Medicine reaffirmed the findings. In testing CBD oil benefits for epileptic seizures, three scientists from the West China Hospital of Sichuan University discovered cannabidiol has an anti-convulsive effect on rats.

Epidiolex was first approved as a treatment in Europe in 2017, when health regulators granted it “orphan” status. It received marketing approval at the end of the same year. The drug was only approved in the United States in 2018, after lengthy consideration.

Is Epidiolex available over-the-counter?

Currently, Epidiolex is only available as a prescription medication. A doctor must write the prescription first, which gets filled by a licensed pharmacy.

Epidiolex should not be confused with other CBD oils, CBD gummies, or CBD capsules. Most CBD products do not require prescriptions to order. However, these CBD products also do not have FDA approval — which means you may have to do some research before making an order.

While it may share benefits with other products, Epidiolex is only dispensed by pharmacists. Any website or “online pharmacy” claiming to have Epidiolex available without a prescription is a scam.

Does Epidiolex showcase CBD oil benefits?

The FDA approval of Epidiolex is a major win for the entire CBD industry. For the first time in history, the FDA acknowledges the bigger picture of CBD oil benefits.

“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,” Dr. Scott Gottleib, commissioner of the FDA, said in a press release. “And, the FDA is committed to this kind of careful scientific research and drug development.”

The announcement opens the door for FDA acknowledgement of other CBD oil benefits. Both peer-reviewed studies and anecdotal experimentation provides evidence on the potential good of CBD-based products.

Scientific studies published by many peer-reviewed journals have lauded the applications for cannabidiol. Much of the research suggests that CBD oil could help many conditions, including stress, arthritis and irritable bowel syndrome.

More important, legitimate acknowledgement is coming for those who already use CBD-based products. According to a survey from HelloMD, over 80 percent of CBD users said they found them “very or extremely effective” and are 42 percent more likely to stop using traditional medications for ailments, like over-the-counter pain medications. Although you should always talk to your doctor before stopping any medication, evidence from current users show there are CBD oil benefits we have yet to discover.

What are the obstacles towards full acceptance of CBD oil?

Despite the approval, cannabidiol-based products has won total de-stigmatization. The FDA has not evaluated other CBD oil benefit claims and those products are not intended to diagnose, treat, cure or prevent any disease.

Moreover, because plant-derived CBD comes from industrial hemp plants, it’s still a Schedule I substance under the Controlled Substances Act. But state-to-state rules about CBD differ. States like California and Colorado have legalized CBD products. Other states regulate CBD products, but enforcement actions often focus on local distributors.

This isn’t bad for the CBD industry. As people seek natural CBD oil benefits, more illegitimate companies produce fake cannabidiols. Through industry self-regulation, individuals can ensure they get only pure, plant-derived CBD oils without toxins or poisons.

The approval of Epidiolex is a big move towards acknowledging CBD oil benefits. With this major hurdle cleared, it may only be a matter of time before modern medicine expands their understanding of the beneficial properties of CBD.

Share this Post