An experimental cannabis-derived medication was safer and more effective than placebo and opioids for treating chronic lower back pain in two late-stage trials, researchers said.
Treatment with VER-01, an extract from cannabis sativa DKJ127 L. being developed by Munich-based Vertanical, also improved pain-related sleep disturbances along with patients’ physical function and quality of life, according to separate reports of the trials.
“VER-01 could transform how we care for patients with chronic lower back pain,” Dr. Charles Argoff of Albany Medical College, who coauthored one of the reports, said in a statement.
“The results of the Phase 3 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,” said Argoff, a past president of the American Academy of Pain Medicine.
In one randomized trial of 820 patients with chronic low back pain, improvements were seen with VER-01 compared with a placebo after 12 weeks and were sustained over 12 months of treatment. The VER-01 group reported a nearly 3-point decrease in pain on a 10-point scale, on average, researchers reported in Nature Medicine, opens new tab.
The VER-01 group also reported significantly greater improvements in sleep quality and physical function compared with the placebo group, researchers said.
A second Phase 3 study, published in Pain & Therapy, opens new tab, compared Vertanical's cannabis drug with opioids in 384 patients with chronic low back pain. Along with superior pain control, patients receiving VER-01 reported less constipation, less laxative use, and better sleep than patients taking opioids.
In both trials, pain reduction with VER-01 was particularly pronounced in patients with severe pain or pain from nerve disorders, the researchers said.
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Treatment with VER-01, an extract from cannabis sativa DKJ127 L. being developed by Munich-based Vertanical, also improved pain-related sleep disturbances along with patients’ physical function and quality of life, according to separate reports of the trials.
“VER-01 could transform how we care for patients with chronic lower back pain,” Dr. Charles Argoff of Albany Medical College, who coauthored one of the reports, said in a statement.
“The results of the Phase 3 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,” said Argoff, a past president of the American Academy of Pain Medicine.
In one randomized trial of 820 patients with chronic low back pain, improvements were seen with VER-01 compared with a placebo after 12 weeks and were sustained over 12 months of treatment. The VER-01 group reported a nearly 3-point decrease in pain on a 10-point scale, on average, researchers reported in Nature Medicine, opens new tab.
The VER-01 group also reported significantly greater improvements in sleep quality and physical function compared with the placebo group, researchers said.
A second Phase 3 study, published in Pain & Therapy, opens new tab, compared Vertanical's cannabis drug with opioids in 384 patients with chronic low back pain. Along with superior pain control, patients receiving VER-01 reported less constipation, less laxative use, and better sleep than patients taking opioids.
In both trials, pain reduction with VER-01 was particularly pronounced in patients with severe pain or pain from nerve disorders, the researchers said.
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