Recent study met primary end point of reduction of numeric rating scale pain intensity in double-blind 12-week treatment phase
By Elana Gotkine HealthDay Reporter
THURSDAY, Oct. 2, 2025 (HealthDay News) — The cannabis extract VER-01 is safe and effective for chronic low back pain (CLBP) in adults, according to a study published online Sept. 29 in Nature Medicine.
Matthias Karst, M.D., from Hannover Medical School in Germany, and colleagues conducted a multicenter, phase 3 trial to examine the efficacy and safety of VER-01 in 820 adults with CLBP. Participants were randomly assigned to receive VER-01 or placebo (394 and 426, respectively). The trial involved a double-blind 12-week treatment phase (phase A) and a six-month open-label extension (phase B), followed by a six-month continuation (phase C) or randomized withdrawal (phase D). A change in mean numeric rating scale (NRS) pain intensity was the primary end point for phase A, while the secondary end point was change in total neuropathic pain symptom inventory (NPSI) score for those with a neuropathic pain component.
The researchers found that the study met the primary end point in phase A, with a mean pain reduction of −1.9 NRS points in the VER-01 group (mean difference, −0.6 versus placebo). In phase B, pain further decreased to −2.9 NRS points, with effects sustained through phase C. The key secondary end point was also met, with a mean NPSI decrease of −14.4 points from baseline in the VER-01 arm (mean difference, −7.3 versus placebo). The incidence of adverse events, mainly mild to moderate and transient, was higher with VER-01 than placebo in phase A. VER-01 was well tolerated.
“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,” the authors write.
Several authors disclosed ties to the pharmaceutical industry.
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