Vertanical’s cannabis-based pain reliever, VER-01, has shown superiority over opioids in a Phase III trial.
In the ELEVATE study (NCT05610813), VER-01 was pitted against opioids, prescribed at the discretion of the investigator, in 384 patients. The trial met its primary efficacy endpoint, with a significantly higher incidence of constipation in the opioid group compared to the VER-01 group.
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Patients receiving VER-01 were four times less likely to develop constipation than those receiving opioids and three times less likely to use laxatives.
VER-01 was also more effective in alleviating pain than opioids, with patients experiencing improved sleep throughout the six months of treatment. Pain reduction was particularly high in patients with neuropathic pain and those with severe pain.
Data has also been announced from a Phase III trial (NCT04940741), which investigated the drug against placebo in 820 patients with chronic lower back pain (CLBP).
This study also met its primary endpoint of significant pain reduction compared with placebo, after 12 weeks of treatment. Patients receiving VER-01 achieved a pain reduction of 1.9 points on the 0-point to 10-point pain numerical rating scale (NRS). The placebo cohort saw a reduction of 1.4 points.
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By GlobalDataIn an open-label extension phase, pain intensity reached a 2.9-point reduction after six months and was sustained over 12 months of continued treatment.
Patients receiving VER-01 also reported significantly greater improvements in sleep quality and physical function compared with placebo.
VER-01 was generally well tolerated in both studies with no evidence of dependence or withdrawal. While mild to moderate adverse events (AEs) were more frequent with VER-01, most occurred only during the initial three-week titration phase.
Albany Medical College’s professor of neurology Charles Argoff said: “These findings provide powerful evidence that VER-01 could transform how we care for patients with chronic lower back pain. The results of the Phase III studies bring hope to millions living with chronic pain that, if approved, VER-01 could deliver effective pain relief while addressing key safety challenges of current therapies.”
Despite not showing a significant difference to placebo in a Phase III trial, the US Food and Drug Administration (FDA) has approved Vertex’s suzetrigine, making it the first novel class of non-opioid pain medication to hit the market in over two decades.
GlobalData forecasts that suzetrigine will reach blockbuster status in 2027 before bringing in $2.59bn in sales in 2031.
GlobalData is the parent company of Clinical Trials Arena.
