FDA Fast-Tracks Cannabis Drug Shown to Control Pain Better than Opioids… and Without Addiction

It was October of 1970, when Presdent Nixon signed the Controlled Substances Act (CSA) into law. In May of the following year, the act’s provisions took effect, and cannabis was deemed to be a “schedule one drug,” alongside only heroin and LSD.

It didn’t matter that cannabis was only supposed to be on that “schedule one list” temporarily to allow for further study, from that point forward the federal government would only consider cannabis to be a dangerous drug having three characteristics:

• High potential for abuse,
• No legitimate medical use in treatment in the United States, and
• Lack of accepted safety for use under medical supervision.

None of that was ever shown to be even remotely true.

The law also created the National Commission on Marihuana and Drug Abuse to review cannabis policy, and that commission would later recommend decriminalizing the possession of small amounts of marijuana… but the Nixon administration chose not to adopt those recommendations because it didn’t fit their narrative.

The simple fact is that the Nixon administration was too busy trying to win elections by being “tough on crime,” and they did everything they could to make sure that “drugs” became synonymous with “crime.” Next thing you knew, the now infamous “War on Drugs” had begun, and instead of shots being fired, people caught smoking a joint were being sent to prison for years.

None of it made sense. None was done with any sort of careful thought or attention. And, all of it failed, objectively and miserably. We know that now.

Despite huge expenditures, aggressive enforcement, and millions of arrests over more than five decades… drug use in this country remains widespread, overdose deaths (from drugs other than cannabis) have risen dramatically, and many of the social costs fell disproportionately on minority communities rather than on drug traffickers.

The times, however, are a’changing.

The latest study by Pew Research, shows that over 88 percent of Americans believe that cannabis should be legal either for medical or recreational purposes. Only 11 percent are left who don’t agree.

It was the 1970s when I first started hearing about cannabis having a medical purpose… I heard that it was being prescribed to help treat glaucoma patients. Next, it was chemotherapy patients that I heard were using the drug medicinally. And since those days, from pain, to anxiety and depression, to PTSD, we’ve learned of dozens of legitimate medical purposes for the cannabis plant and its derivatives.

Unquestionably, that’s why today there are 42 U.S. states and Washington, D.C., that have legalized cannabis for medical use. (Twenty-four of those states have also legalized cannabis for adult recreational use.) And yet, the FDA has refused to approve development of a single prescription drug that uses THC as its significant active ingredient… UNTIL NOW.

The drug that could finally break America’s deadly dependence on opioids.

Just last month, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to VER-01, a cannabis-derived, full-spectrum drug designed to treat chronic back pain… more effectively than opioids… and without addiction or other debilitating side effects.

The Breakthrough Therapy Designation is intended to “expedite the development and review of investigational medicines where preliminary clinical evidence indicates the potential for substantial improvement over available therapies.” So, it’s now on the fast track, if you will.

VER-01 is produced by German company Vertanical. Their website describes the company as: “a globally leading biopharmaceutical company specializing in the development and distribution of innovative therapies for the treatment of chronic pain.”

Vertanical’s scientists spent the last eight years in research and development of the new drug. The “Breakthrough” designation follows two randomized, controlled Phase 3 trials, both of which “demonstrated significant pain reduction, a favorable tolerability profile, and no evidence of dependence.”

Think about that for a moment. As compared with opioids, VER-01, was shown to achieve:

• Greater pain reduction.
• “Favorable tolerability,” primarily meaning that constipation was not an issue.
• No evidence of dependence, so it’s NOT ADDICTIVE.

FACT: The opioid crisis might not have happened if this cannabis drug existed sooner.

Can you even imagine how much better the world will be when we can treat chronic pain more effectively and without highly addictive opioids? According to the Centers for Disease Control and Prevention, (CDC), since 1999, this country has lost almost a million people to opioid overdose. In 2023 alone, over 105,000 died.

How many would still be alive if VER-01 had been available… instead of doctors having few effective options beyond Oxycodone and fentanyl? The number of lives that would have been improved in major ways is truly incalculable.

There’s no debate about the fact that chronic pain remains, as Vertanical phrased it in its recent press release, “one of the largest unmet needs in healthcare.” The company says that over a billion worldwide live with chronic pain, 60 million are Americans. And most are still being prescribed opioids, despite the abundance of well-documented risks, including addiction, dependence, and horrible side effects.

Let there be no doubt: Opioids are harming lives and killing people.

It is long past time that we allow our scientists to research the potential therapeutic effects and benefits contained within the cannabis plant. It’s both tragic and absurd that we’ve waited this long to do so.

We urgently need effective, well-tolerated, non-opioid treatment options in the United States, and yet innovation in chronic pain treatment has not been prioritized as compared with other major diseases.

Vertanical says that “VER-01 represents a differentiated investigational approach in a field still shaped by long-standing treatment paradigms,” and to that, we at Deltrium loudly say: BRAVO, and thank you!

(And, just in case I know what you’re thinking… No, you can’t buy stock in Vertanical. The company is a closely held, private company funded by founder and pharmaceutical billionaire Dr. Clemens Fischer, who, by the way, says he’s never smoked cannabis in his life. The company’s new VER-01 drug will be marketed under the brand name: Exilby.)

So, a 1970 Nixon-Era mistake delayed a medical breakthrough for half a century.

That’s what happened, and we should be able to see it clearly now.

Isn’t it long past time to stop the hysterics around cannabis? It’s only coming from 11 percent of us, and even though they’re inordinately loud for their diminutive size, they’re also very, very wrong… and this Breakthrough Therapy Designation by the FDA of VER-01, a full-spectrum cannabis-based prescription drug, SHOULD go a long way to silencing at least some of those critics.

In the meantime, our legislators are debating the future legal status of cannabis and hemp all over the country and in Washington D.C. every day. One prohibitionist reaction actually was slipped into the last budget reconciliation bill, and is threatening to return everything to illegal status again on December 1, 2026, if not overturned or amended before then.

If that seems ridiculous, it’s because it is. There’s just no other way to phrase it at this point. Cannabis obviously has legitimate medical applications, just ask the 42 states that have passed state laws allowing medical cannabis… or the U.S. Food & Drug Administration (FDA), for heaven’s sake.

If you agree and are of a mind to help, you can make a difference by writing to your congressional representatives and senators today to express your support for regulated, legal THC. Now is when your voice will be heard, there are thousands of letters and phone calls coming in every day and your representatives very much want to know where their constituents stand on this issue.

Let congress know that we don’t want to go back to the days of irrational prohibition and black markets. Our states need the tax revenue that a well-regulated, legal cannabis brings. We’ve already got 42 states plus the District of Colombia that have legalized cannabis in one form or another. Isn’t it embarrassing that we’re still talking about this?

Well, let’s put it to bed, once and for all. Tell your representatives how you feel today.

TO FIND YOUR ELECTED REPRESENTATIVES IN WASHINGTON:

FIND YOUR CONGRESSIONAL REPRESENTATIVES

FIND YOUR SENATORS

(Thanks for taking the time to read this article. To contact the author, send emails to: martin@deltrium.com.)