Finally a treatment that works for chronic low back pain?

Chronic low back pain (CLBP) affects over half a billion people worldwide. Current pharmacologic treatments offer limited efficacy and carry substantial risks, warranting the development of safe and effective alternatives. This multicenter, randomized, placebo-controlled phase 3 trial evaluated the efficacy and safety of the herbal extract VER-01 in CLBP.

It enrolled 820 adults with CLBP (VER-01, n = 394; placebo, n = 426) and included a double-blind 12-week treatment phase (phase A), a 6-month open-label extension (phase B), followed by either a 6-month continuation (phase C) or randomized withdrawal (phase D). The primary endpoint of phase A was a change in mean numeric rating scale (NRS) pain intensity, with a change in total neuropathic pain symptom inventory (NPSI) score as a key secondary endpoint in participants with a neuropathic pain component (PainDETECT > 18). The primary endpoint for phase D was time to treatment failure.

The study met its primary endpoint in phase A, with a mean pain reduction of -1.9 NRS points in the VER-01 group (mean difference (MD) versus placebo = -0.6, 95% confidence interval (CI) = -0.9 to -0.3; P < 0.001). Pain further decreased to -2.9 NRS points in phase B, with effects sustained through phase C. The study also met its key secondary endpoint of phase A, with a mean NPSI decrease of -14.4 (standard error, 3.3) points from baseline in the VER-01 arm (MD versus placebo = -7.3, 95% CI = -13.2 to -1.3; P = 0.017). Although phase D did not meet its primary endpoint (hazard ratio = 0.75, 95% CI = 0.44-1.27; P = 0.288), pain increased significantly more with placebo upon withdrawal (MD = 0.5, 95% CI = 0.0-1.0; P = 0.034). In phase A, the incidence of adverse events-mostly mild to moderate and transient-was higher with VER-01 than with placebo (83.3% versus 67.3%; P < 0.001). VER-01 was well-tolerated, with no signs of dependence or withdrawal.

The authors of this well-designed trial concluded that this phase 3 study provides robust evidence supporting the efficacy and safety of VER-01 in the treatment of CLBP. These findings highlight the importance of further research with VER-01 in other chronic pain conditions and suggest that VER-01 could play an important role in modern pain management.

VER-01 was developed by the German biopharmaceutical company Vertanical. It is a standardized full-spectrum extract from a specific Cannabis sativa strain (DKJ127 L). This means it contains a defined mix of the plant’s compounds, including cannabinoids (such as low levels of THC—tetrahydrocannabinol—and trace amounts of CBD and cannabigerol), terpenes, and other bioactive compounds like beta-caryophyllene and alpha-bisabolol. It is designed to harness the synergistic “entourage effect” of these compounds.

The extract has also recently been shown to be superior to opioids. An RCT concluded that VER-01 demonstrated superiority over opioids in treating CLBP, both in terms of efficacy and gastrointestinal tolerability.

PS

Given the option of either having spinal manipulation (or any other form of unproven so-called alternative medicine) or a safe and standardised cannabis extract, I certainly know what I would choose!

PPS

Vertanical has submitted marketing applications for approval in several European countries (where it is expected to be sold under the brand name Exilby if approved). The company is also preparing for a late-stage trial in the US to support a subsequent filing with the FDA. If approved, VER-01 would be the first full-spectrum cannabis extract authorized specifically for chronic low back pain and potentially a new class of medicine for chronic pain management.