FDA-approved Epidiolex set to crack the CBD industry wide open

The approval of Epidiolex paves the way for future medicinal and commercial uses of CBD

(Photo by Images Money via Flickr. CC BY 2.0)

With the official approval by the FDA for GW Pharmaceuticals developed Epidiolex, the first cannabidiol (CBD)-derived pharmaceutical drug on the market, many were wondering what the price tag would be. Epidiolex has been proven to help treat rare childhood epilepsy such as Dravet syndrome and Lennox-Gastaut syndrome, which are characterized by severe seizures and haven’t been responsive to traditional forms of medication.

The UK-based pharmaceutical giant revealed the price tag for patients: around $32,500 per year, with a waiting period of three weeks. According to GW Pharmaceutical CEO Justin Gover, “This first U.S. approval not only represents a transformative milestone for our company but a historic medical breakthrough, offering patients and their families the first and only FDA approved CBD medicine to treat two severe, childhood-onset epilepsies. These deserving patients will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”

Epidiolex was run through a series of research and testing to confirm its efficacy in treating epilepsy. In a 14 week trial test on 225 people diagnosed with Lennox-Gastaut syndrome, the patients were separated into three groups including one that was administered a daily dose of 20mg of CBD, another group receiving a daily dose of 10mg of CBD, and a placebo group.

The 20mg group experienced a 42% decrease in seizure frequency, with 40% having their seizures cut in half or more. In the 10mg group, patients saw a 37% drop in seizures. with 36% having them reduced by half or more. There was a 17% decrease in the placebo group, with 15% experiencing a reduction of half or more.

“This approval serves as a reminder,” Scott Gottlieb, the FDA commissioner, said in a statement on Monday, “that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies.”

A monumental victory

As CBD falls into the same classification as marijuana, both cannabinoids operate in a rather confusing area in terms of legality. While marijuana and CBD are both available for use in several states, they are still illegal on the federal level. This has somewhat hampered the use of CBD, as it still retains a relatively negative stigma due to its similarity to marijuana.

Despite the hefty cost, the approval of Epidiolex is a major breakthrough for the CBD industry as CBD is expected to be removed from the list of controlled substances. CBD and marijuana are both listed as Class 1 schedule drugs, which are defined as having no medical value and a high likelihood of abuse.

Once the DEA reclassifies CBD, Epidiolex will be available for patients in the US. DEA public affairs officer Barbara Carreno stated, “We don’t have a choice on that,” Carreno said. “It absolutely has to become Schedule 2, 3, 4, or 5.”

The DEA has stated that only CBD and other cannabinoids sourced from cannabis containing over 0.3% THC, leaving hemp-derived CBD out of the scope of federal scrutiny. Their directives only target marijuana, emphasizing the fact that the presence of cannabinoids doesn’t automatically classify something as a classified substance.

Epidiolex itself contains less than 0.1% of THC.

Opening new doors

The approval of the first CBD pharmaceutical drug will have far reaching effects (Photo by Activedia via Pixabay.)

With the health benefits of CBD continuing to be documented, the sector and consumers alike will benefit greatly from the legalization of CBD, allowing easier access and removing any negative associations with its use. Its lack of psychoactive effects have made it particularly popular among consumers who benefit from its ability to treat a wide variety of common symptoms such as anxiety, depression, and pain.

CBD continues to gain attention for its amazing potential to treat even neurological diseases such as Parkinson’s, Alzheimer's, multiple sclerosis, and even brain cancers. “There are neuroscientists who are drooling to work on this,” said Elizabeth Thiele, director of the pediatric epilepsy program at Massachusetts General Hospital and one of the lead investigators in the GW trials.

Following the DEA’s rescheduling of CBD, this will allow for greater range of research opportunities such as testing its efficacy in treating neurological diseases. GW Pharmaceuticals is undergoing testing on Epidiolex to determine its ability to help patients with tuberous sclerosis, another disease characterized by seizures.

It has also capitalized on the approval of Epidiolex and is now pursuing the approval of Sativex, a mouth spray containing THC and CBD that is used for treating cancer pain and multiple sclerosis.

Many choices

The price tag for Epidiolex is understandably going to be out of the financial range of many families seeking effective treatments for childhood epilepsy, and many are likely to turn to cheaper CBD products that are commonly sold at dispensaries around the country. Quality products will become even more widely available once CBD’s Class 1 schedule classification is amended.

The CBD industry is already dominated by the likes of companies such as PotNetwork Holdings, Inc. (OTCMKTS:POTN) Their meticulous research and development coupled with supercritical CO2 extraction produces quality CBD oils derived from hemp, which are limited to 0.3% THC or less. This makes it ideal for its wide consumer base due to its lack of psychoactive effects and the fact that it is derived from organic hemp, not marijuana.

POTN distributes quality edibles like Chill Gummies and Relax Gummies, while also provide popular methods of CBD use such as vapes, tinctures, and healing creams aimed at soothing common pain such as those resulting from physical activity.

Once Epidiolex becomes officially available, sales are projected to reach around $1.3 billion by 2022, and it will pave the way for additional research and medicinal products while also increasing the positive visibility of commercialized CBD products such as those from POTN.