An experimental cannabis-based medication has demonstrated significant efficacy in treating chronic lower back pain in a large-scale clinical trial, offering new hope for millions of patients who have limited treatment options for this debilitating condition. The 800-patient study by German drugmaker Vertanical represents the latest evidence supporting the therapeutic potential of pharmaceutical-grade cannabis for pain management.
Clinical Trial Results
The randomized, placebo-controlled study showed statistically significant pain reduction among patients taking Vertanical's proprietary liquid cannabis extract. After 12 weeks of treatment, participants reported a nearly 2-point reduction in pain on an 11-point scale, compared with 1.4 points for those receiving placebo. Patients also experienced improvements in sleep quality and physical function.
The therapeutic benefits continued during a six-month extension phase, with patients maintaining pain reduction over the longer treatment period. Results were published Monday in the journal Nature.
Lead study author Dr. Matthias Karst, a pain specialist at Hannover Medical School and consultant for Vertanical, stated that the findings demonstrate cannabis "can significantly reduce pain and improve physical function in patients with chronic low-back pain, without the safety concerns commonly associated with opioids."
Drug Composition and Safety Profile
Unlike CBD-only formulations such as the FDA-approved Epidiolex for pediatric epilepsy, Vertanical's cannabis formula contains THC, the psychoactive component of marijuana. However, the THC levels are extremely low—essentially a microdose compared to recreational cannabis products available at dispensaries.
The company reported that patients in the trial showed no signs of drug abuse, dependence, or withdrawal. While driving is not recommended during the initial weeks of treatment, the decision was ultimately left to individual patients based on their response to the medication.
Safety and Tolerability
Side effects included dizziness, headache, fatigue, and nausea, leading to discontinuation in more than 17% of participants. Researchers noted this dropout rate was lower than what is typically reported with opioid medications, which can cause constipation, nausea, drowsiness, and carry significant addiction risks.
Addressing Unmet Medical Need
Chronic lower back pain affects millions of patients worldwide and has few proven treatment options. Over-the-counter pain relievers like ibuprofen cannot be used long-term due to side effects including stomach ulcers and indigestion. Opioids are no longer recommended following the addiction epidemic that resulted from overprescribing painkillers such as OxyContin in the 1990s and 2000s.
Chronic pain represents one of the most frequently cited conditions among patients enrolled in state-run medical marijuana programs, yet rigorous research on cannabis use in this population has been limited until now.
Regulatory Pathway
Vertanical has filed an application with European regulators for drug approval. In the United States, the company is "working closely" with regulators to design a study that would support FDA approval.
The regulatory landscape for cannabis-based medications remains complex, as cannabis remains federally illegal in the U.S. despite widespread state-level legalization for medical and recreational use. Health officials in Canada and Europe have previously approved pharmaceutical-grade cannabis for various pain conditions, including nerve pain associated with multiple sclerosis.
