CBD Enters the Pharmaceutical World

While old adages become inane rather quickly, it’s still true that a journey of a thousand miles begins with that first step. With Epidiolex, a first step has been taken with the stamp of approval for the first and only US Food and Drug Administration-approved prescription cannabidiol with 98 per cent CBD and zero per cent THC.

GW Pharmaceuticals/Greenwich BioSciences officially opened the pharmaceutical channel when they announced the availability of Epidiolex, a prescription medication used to treat seizures in younger patients. Billed as “a treatment breakthrough,” the product contains a highly purified form of CBD whose active ingredient is nearly 100 per cent cannabidiol.

Once FDA approval had been given, it became the first prescription pharmaceutical formulation of highly-purified, plant-derived cannabidiol, and the first in a new category of anti-epileptic drugs.

Some industry pundits called it an iconic movement in the marijuana world and a vital step in acknowledging that cannabis has a valid medical use, hopefully loosening restrictions that have kept scientists from researching health benefits of cannabis.

“That story began about eight years ago when our researchers were doing pre-clinical work on CBD and CBDV (cannabidiveran), different but related molecules,” says GW Pharmaceuticals vice-president Stephen Schultz.

“It’s a complex route to run clinical studies, but to do so with a new molecule that’s never been tested before is more challenging, time consuming, and expensive because you need Drug Enforcement Administration clearance involving Schedule 1 products. But we ended up with a first-time FDA-approved cannabis plant-derived medicine for the marketplace, and we intend to do more of that.”

Read also:Can Cannabis Treat Epilepsy?

One thing being revealed at the onset is this could be a money-making star product as second quarter shares in GW Pharmaceuticals surged on the back of the company’s fiscal 2019 second-quarter results, which posted sizeable growth numbers. The quarter’s revenue came in at more than $72 million, nearly doubling analysts’ expectations, and the product almost solely credited for the impressive rise was Epidiolex with net sales of more than $68 million during the quarter.

And while this ground-breaking approval of product-to-market is newsworthy and laudatory for opening that door, our focus here is not on the specific product itself, but the fact that CBD is now officially a player of record in the pharmaceutical marketplace. As the company acknowledges: “Our mission is to unlock the potential of cannabinoid medicines.”

As other CBD pharmaceuticals begin to receive governmental approval, that segment of the industry is anticipated to very quickly account for one-third of the total CBD market. In fact, early forecasts for the newly approved product alone show it generating annual sales of $1.1 billion by 2021.

Because CBD is just one of more than 100 active cannabinoids in the cannabis plant to interact with body receptors responsible for maintaining homeostasis and with more than 1,500 published scientific studies attesting to cannabidiol’s beneficial health effects, it’s natural for Big Pharma to be salivating at future prospects.

“We’ve got a plethora of data on various cannabinoids for a wide variety of therapeutic targets and are testing them, individually and in combination,” Schultz says. “While THC is the best-known cannabinoid for recreational purposes, our philosophy is that some of the secondary cannabinoids like CBD, CBDV, and others may have therapeutic potential.

“Products that go through the regulatory route provide both physician and patient confidence and I don’t think that’s the case with some of the other segments of this larger market, but the market is evolving and the FDA is going to play a role in that evolution by putting guidelines in place on how you can bring CBD products to market, what their levels of concentration will be, and how and where you can sell them.”

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New discoveries are regularly being made now about CBD’s potential in the treatment of cancer, heart disease, anxiety reduction, substance abuse, and more.

A recent update (Project CBD) indicated Harvard University scientists were showing encouraging results from a clinical trial to assess the impact of a high-CBD/low-THC sublingual tincture for anxiety patients, specifically that a custom-formulated whole plant-derived high CBD sublingual had resulted in fewer anxiety-related symptoms.

In the United Kingdom, where, in 2010, GW Pharmaceuticals developed Sativex, the world’s first prescription cannabis-derived drug to treat multiple sclerosis (with plans to bring it to the US soon), the University of Nottingham is examining both acute and chronic effects of cannabidiol on cardiovascular function, already noting that oral administration of 600 mg of CBD causes a reduction in blood pressure.

In other cutting-edge pre-clinical research, CBD is being studied in reference to ischemic stroke and induced brain injuries.

As with any startup industry, time and a learning curve will be involved before clarity is achieved. “I think the entire spectrum is quite unclear at this point,” says Schultz. “But what is crystal clear is that if you develop cannabinoid-based products through the FDA regulatory route, that’s the preferred route, the only one that allows you to make medical claims. Everything else is still evolving and developing and subject to some considerable shifting of the sands as the process moves forward.”