Chronic pain affects millions of people worldwide. The often-debilitating condition is typically treated with over-the-counter pain relievers or opioid medications. However, both of these mainstream medicines have risks—some of which have led to severe public health crises. Anecdotally, cannabis has been found to reduce pain for many patients. Now, one pharmaceutical maker is on the verge of introducing a new cannabis-based drug to the market that could change the game forever.
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German drug company Vertanical has been developing a full-spectrum marijuana extract for chronic low back pain, currently referred to as VER-01. Vertanical recently released the findings of its large-scale, peer-reviewed, randomized, placebo-controlled Phase 3 trial—and the results were promising. More than 800 volunteers with chronic back pain participated in the study.
For the new study, patients with chronic back pain were randomly assigned to take Vertanical’s proprietary full-spectrum cannabis extract or a placebo. The sesame oil-based liquid contains 2.5 mg THC, 0.1 mg cannabigerol (CBG), 0.02 mg cannabidiol (CBD), along with terpenes and other plant compounds.
After 12 weeks, patients on the drug reported nearly a 2-point reduction in pain on an 11-point scale, compared with 1.4 points for placebo. Importantly, the researchers noted the difference was statistically significant. Side effects included dizziness, headache, fatigue, and nausea, leading more than 17 percent of participants to discontinue treatment early.
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Those getting the drug also reported improvements in sleep and physical function. Patients who entered the six-month extension phase maintained their pain improvements.
The study’s ethics report disclosed that some team members had received honoraria or institutional contributions from pharmaceutical companies, universities, and other organizations.
Lead study author Dr. Matthias Karst told the Associated Press that the new findings show cannabis “can significantly reduce pain and improve physical function in patients with chronic low-back pain, without the safety concerns commonly associated with opioids.” Karst is a pain specialist at Hannover Medical School and a consultant for Vertanical.
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Chronic pain is among the most common reasons patients enroll in state-run medical marijuana programs. But FDA approval of a cannabis-derived drug for the condition could widen access and potentially reduce costs through insurance coverage.
Vertanical has filed an application for its drug with European regulators. In the U.S., the company says it is “working closely” with regulators to design a study to support FDA approval. While the process may take time, its progress offers hope that millions of patients may find relief sooner rather than later.
*The Associated Press contributed to this report.
