Gräfelfing (ots) – The biopharmaceutical company VERTANICAL has published the results of two clinical phase 3 studies on VER-01 in the specialist journals Nature Medicine and Pain & Therapy and presented them to a wider specialist public for the first time at the German Pain Congress. The novel cannabinoid-based medicine has been evaluated for efficacy and safety in the treatment of chronic low back pain (CLBP) – the world’s leading cause of chronic pain.
The results suggest a potential breakthrough in the treatment of chronic low back pain.
The studies show that VER-01 provides superior pain relief and tolerability to opioids – with no evidence of dependence or abuse risks[1]. In addition, the treatment led to significant improvements in central accompanying symptoms such as sleep disorders or mobility restrictions, which overall led to a significant improvement in the patients’ quality of life[2].
“VER-01 has the potential for first-line therapy in the pharmacological treatment of chronic back pain: significant pain reduction, better sleep quality and improved mobility,” says Prof. Dr. Matthias Karst, first author of the study published in Nature Medicine and head of the pain clinic at the Hannover Medical School.
Chronic low back pain affects more than half a billion people worldwide and is considered one of the most common causes of lost work time, disability and reduced quality of life[3],[4]. Currently available pharmacological treatment options are predominantly limited to nonsteroidal anti-inflammatory drugs (NSAIDs), whose use is only recommended for short periods of time due to significant gastrointestinal and cardiovascular risks, and to opioids, which are often associated with serious side effects such as constipation and a high potential for dependence[5],[6],[7].
Dr. Philipp Müller-Schwefe, head of the Göppingen Pain and Palliative Care Center and study leader of one of the participating study centers, comments on the study results as follows: “VER-01 could be a safe and more effective alternative for many chronic back pain patients who could only be inadequately treated with previously available therapies.”
VER-01 demonstrates superiority over placebo in pivotal phase 3 study
In a placebo-controlled, double-blind Phase 3 study of 820 patients published in Nature Medicine, VER-01 achieved a significant reduction in pain compared to placebo, meeting the study’s primary endpoint. After 12 weeks of treatment, pain intensity with VER-01 decreased by 1.9 points on the 0 to 10 numerical pain scale (NRS). In a subsequent open extension phase, the pain intensity continued to decrease by a total of 2.9 points over six months of treatment and remained stable at a low level over 12 months.
The effect was particularly pronounced in patients with neuropathic or severe pain. In addition, sleep quality and mobility improved significantly more under VER-01 than under placebo. VER-01 was well tolerated overall, with no evidence of dependence or abuse risks.
VER-01 demonstrates superiority over opioids in the ELEVATE comparative study
A second phase 3 study (“ELEVATE”) published in Pain & Therapy directly compared VER-01 with opioids. The study with a total of 384 patients showed a clear superiority of VER-01 over opioids, both in terms of effectiveness and tolerability.
The primary endpoint of the study was the incidence of constipation – a side effect typical of opioids that is often associated with significant impairments in the quality of life of those affected. Constipation occurred four times less frequently with VER-01 than in the opioid group. At the same time, the use of laxatives was three times lower. The primary endpoint of the study was therefore clearly achieved.
In addition, VER-01 also showed significantly better effectiveness than opioids in reducing pain and led to a significant improvement in sleep quality over the six-month treatment period. The benefits of VER-01 were particularly pronounced in patients with neuropathic or severe pain.
“The results of the ELEVATE study are the first scientifically published comparative data that demonstrate the potential of VER-01 as an effective and safer alternative to opioids for chronic back pain,” explains Prof. Dr. Thomas Herdegen, renowned pain researcher and winner of the German Pain Prize.
About VER-01
VER-01 is a standardized full-spectrum extract from Cannabis Sativa DKJ127 L. The phytochemical signature of VER-01 includes a clearly characterized specific composition of several hundred bioactive substances, including cannabinoids, terpenes and other herbal ingredients such as cannabigerol, alpha-caryophyllene and beta-bisabolol, which act synergistically and contribute to the pharmacological effect of VER-01 (“entourage effect”). VER-01 is manufactured using a proprietary extraction process designed to preserve the full spectrum of bioactive plant components.
Based on the compelling Phase 3 results, VERTANICAL has filed for approval of VER-01 for the treatment of chronic low back pain in several European countries. Another pivotal Phase 3 study in the US is scheduled to begin in 2026 to prepare for approval of VER-01 in the US.
About VERTANICAL
VERTANICAL is a leading biopharmaceutical company specializing in the development and distribution of innovative medicines for the treatment of chronic pain. The company pursues the vision of a world free from chronic pain. With over 20 completed preclinical and clinical studies and a comprehensive development program across various chronic pain indications, VERTANICAL is one of the world’s leading companies in the chronic pain sector.
VERTANICAL was founded in 2007 and is based in Gräfelfing near Munich. The company operates one of the world’s most modern GMP facilities for the development and manufacturing of biological medicines. It maintains an international network of several hundred research and clinical study centers in the USA and several European countries.
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1 Meissner W, Argoff C, Sator S, Schoder V, Karst M. VER-01 shows enhanced gastrointestinal tolerability, superior pain relief, and improved sleep quality compared to opioids in treating chronic low back pain: a randomized phase 3 clinical trial. Pain Ther (2025), published online on September 30, 2025, doi:10.1007/s40122-025-00773-z
2 Karst M, Meissner W, Sator S, Keßler J, Schoder V, Häuser W. Full-spectrum extract from Cannabis sativa DKJ127 for chronic back pain: a randomized, placebo-controlled phase 3 study. Nat Med (2025), published online on September 29, 2025, doi: 10.1038/s41591-025-03977-0
3 Wu A, March L, Zheng X, et al. Global low back pain prevalence and years lived with disability from 1990 to 2017: estimates from the Global Burden of Disease Study 2017. Ann Transl Med. 2020;8(6):299. doi:10.21037/atm.2020.02.175
4 GBD 2021 Low Back Pain Collaborators. Global, regional, and national burden of low back pain, 1990-2020, its attributable risk factors, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023 May 22;5(6):e316-e329. doi: 10.1016/S2665-9913(23)00098-X. PMID: 37273833; PMCID: PMC10234592.
5 Salvo F, Antoniazzi S, Duong M, et al. Cardiovascular events associated with the long-term use of NSAIDs: a review of randomized controlled trials and observational studies. Expert Opin Drug Saf. 2014;13(5):573-585. doi:10.1517/14740338.2014.907792
6 Wirth T, Lafforgue P, Pham T. NSAID: Current limits to prescription. Joint Bone Spine. 2024 Jul;91(4):105685. doi: 10.1016/j.jbspin.2023.105685. Epub 2023 Dec 29. PMID: 38159794.
7 Vowles KE, McEntee ML, Julnes PS, Frohe T, Ney JP, van der Goes DN. Rates of opioid misuse, abuse, and addiction in chronic pain: a systematic review and data synthesis. Pain. 2015;156(4):569-576. doi:10.1097/01.j.pain.0000460357.01998.f1
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