Findings from the successful trials of a new, multi-compound, cannabis medicine look set to deliver a major breakthrough for the world’s half-a-billion chronic low back pain (CLB) sufferers.
Just a few months ago, we reported on the success of German company Vertanical in passing through the arduous Randomised Control Test (RCT) procedure for its VER-01 drug.
With the results of the trials now in the public domain, it transpires that not only was VER-01 able to alleviate pain up to twice as effectively as opioids, it was also found to improve sleep, and patients did not experience one of the alternative’s downsides, namely, OIC (Opioid-Induced Constipation).
This positions VER-01 to become the first medical cannabis blockbuster drug, operating in a global annual market worth $3bn, and far outstripping Jazz Pharmaceuticals’ Epidiolex with annual sales of $100m.
The significance of this development cannot be underestimated. VER-01, to be marketed as Exilby, delivers a whole-plant, stable, consistent and repeatable medicine, based on proven science, in a way existing ‘flower’ prescriptions cannot.
As such, it opens up a new and uncontroversial pathway for prescribing cannabis; one that even an ultra-conservative, prohibition-baked, medical profession cannot ignore.
‘Shift the paradigm’
The two RCT studies involved over 1,300 patients, with one of the two trials concluding: “This study provides robust evidence that VER-01 offers better tolerability, as well as superior pain relief and sleep quality compared to opioids in patients with CLBP.
“These findings highlight its potential as a promising new pharmacological option within a multimodal treatment approach that could fundamentally shift the paradigm in the treatment of chronic pain.”
The other study reached similar conclusions: “These results are of high clinical relevance, as substantiated by a significantly higher proportion of participants randomised to VER-01 achieving well-recognised thresholds of meaningful pain relief, including a ≥30% and ≥50% pain reduction.”
“These results are particularly relevant given the substantial unmet medical need in CLBP, where many patients remain inadequately treated due to the inherent limitations of current pharmacological options, primarily NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) and opioids
This study involved 820 people and was conducted at 66 outpatient sites, and university-based hospitals, in Germany and Austria.
Whilst the former – known as the ELEVATE study – consisted of 384 people at 41 outpatient sites and hospitals in Germany, the Czech Republic, Poland and Spain.
60m suffer from opioid addiction
With Vertanical set to release VER-01 into the European market next year this could initiate a seismic shift in the pain-relief drug sector.
It is currently dominated by opioid-based treatments with a number of debilitating side effects, such as addiction and OIC.
More than 60m people worldwide are thought to struggle with opioid addiction or dependence, and over-the-counter pain relievers like ibuprofen aren’t safe for long-term use.
Despite some 800,000 opioid-related deaths between 1999 and 2023, one in five US patients suffering from acute pain are still on these drugs due to a lack of alternatives.
The studies highlight how VER-01 is particularly effective in easing neuropathic pain – chronic pain from nerve damage or disease – whilst concluding there was no evidence of patients suffering from withdrawal systems after the trial’s conclusion.
The make-up of VER-01
VER-01 contains over 100 compounds, compared to the single or dual compound CBD/THC combinations of other approved cannabis medicines.
The smaller cohort study disclosed further details of the nature of VER-01, saying it is a full-spectrum extract from cannabis sativa strain DKJ127, containing 2.5mg of THC, 0.1mg of cannabigerol and 0.02mg of cannabidiol.
The study report continues: “As a full-spectrum cannabis extract, VER-01 contains a complex mixture of cannabinoids, terpenes, and other bioactive compounds, such as cannabigerol, β-caryophyllene, and α-bisabolol, that contribute to its overall pharmacological effects.
“Cannabigerol has been shown to exert anti-nociceptive (pain) effects, particularly in models of neuropathic pain, while β-caryophyllene and α-bisabolol possess anti-inflammatory effects by down-regulating pro-inflammatory mediators.’
It is administered orally, as liquid drops, in a carrier sesame oil with additional anti-oxidant flavonoids and carotenes.
Europe, then the US
The condition VER-01 targets offers a significantly larger market opportunity than other approved cannabis medicines and is expected to surpass the sales of drugs such as Sativex, which was first approved in the UK in 2010.
It consists of a one-to-one ratio of THC to CBD for the treatment of multiple sclerosis, with further GW Pharmaceuticals (now Jazz Pharmaceuticals) products now available, including Epidiolex to treat rare forms of epilepsy.
The report authors concluded: “Overall, these findings position VER-01 as a promising, non-addictive, well-tolerated, and effective alternative, particularly for long-term use.”
Vertanical was founded by Clemens Fischer, a medical doctor and founder of the Munich-based Futrue Group. VER-01 has been seven years in the making at a cost of over $250m to date.
With approval as an ‘authorised medicinal product’ in Germany, the ‘mutual recognition procedure’ will allow it access to the rest of the European Union market.
As well as Europe, it is looking at the UK and US markets with trials underway in both countries.
In the UK, the results of its Phase 2 trial at St Pancras Hospital in London, which was completed in July this year, are currently being assessed, and it is set to launch a Phase 3 study in the US.
The company told us, “Being in communication with the FDA (Food and Drug Administration) we believe we can overcome the hurdles by providing significant data.”
