VER-01 cannabis drug approved for back pain in Germany

Q: What is VER-01 and what is it approved for?

VER-01 is a liquid cannabis-derived medication containing THC and CBD that recently received market authorization in Germany and Austria for back pain with a neuropathic component, marketed as Exilby.

Q: How effective is VER-01 compared with placebo and opioids?

In the approval study, VER-01 showed an average 1.5-point improvement on the pain scale, with a 0.5-point difference over placebo on the primary outcome, and proponents cite studies suggesting it can relieve pain better than opioids.

Q: Why are some pain specialists skeptical of VER-01?

Ulrike Bingel of University Hospital Essen argued that statistical significance does not equal clinical relevance, noting that pain relief varied too much across study subgroups, while Jan-Peter Jansen of the Schmerzzentrum Berlin called the new substance class an important additional option for pain physicians.

Berlin, 11 June 2026 A cannabis-derived medication named VER-01, marketed in Germany as Exilby, has received market authorization in Germany and Austria for back pain with a neuropathic component, with proponents citing opioid-comparable relief and critics questioning the size of the effect. The active substance VER-01 recently received market authorization in Germany and Austria under the name VER-01 for the indication of back pain with a neuropathic component. The prescription-only medication, marketed as Exilby, consists of a liquid combination of active ingredients extracted and processed from the cannabis plant, including the intoxicating THC and cannabidiol (CBD). It is administered as drops from a bottle with a pipette. In the approval study, the average pain improvement on the numerical pain intensity scale was 1.5 points for patients receiving VER-01, and the substance achieved 1.5 points better pain reduction than placebo on average. The numerical rating scale (NRS) ranges from 0, meaning no pain, to 10, meaning the worst imaginable pain. The difference in the primary outcome between VER-01 and placebo, however, was only 0.5 points, a figure that has fueled debate among specialists. "Die Studie dokumentiert eine statistisch signifikante Schmerzreduktion mit VER-01 auf der Grundlage der numerischen Schmerzintensitätsskala… Darüber hinaus benötigten die Teilnehmer der VER-01-Gruppe weniger Notfallmedikamente als die Teilnehmer der Placebogruppe," the approval documentation states. With the indication, the medication can be prescribed for nearly all pains in the lumbar spine region that radiate into the lower extremities. ## Study data and the placebo question Clemens Fischer, head of the pharmaceutical company Futrue, headquartered in Gräfelfing in Bavaria, west of Munich, has argued that the drug outperforms opioids. "Studien haben gezeigt, dass unser Wirkstoff Schmerzen besser lindern kann als Opioide," Fischer told the Tagesspiegel. Opioid-containing medications for chronic pain, by comparison, achieve only an average improvement of 0.5 to 0.8 points. In Germany, opioid-based medications such as tilidine, fentanyl, and oxycodone were prescribed to back pain patients only in very low doses and for a very limited time, according to Jan-Peter Jansen, head of the Schmerzzentrum Berlin and Vice President of the German Society for Pain Medicine (Deutsche Gesellschaft für Schmerzmedizin). "Eine neue Substanzklasse wäre eine wichtige weitere Option für Schmerzmedizinerinnen und -mediziner," Jansen said, welcoming the new therapeutic class. Jan-Peter Jansen noted that in chronic pain patients, the placebo response rate is typically around 40 percent, a very high figure that complicates interpretation of trial results. Doctors titrate patients onto the medication, increasing the dose until the patient experiences significant symptom relief while side effects remain manageable. ## Side effects and U.S. regulatory signal Reported side effects include dizziness, drowsiness, and nausea. Andrea Hohmann, professor of psychology and brain research and head of the Pain and Addiction Lab at Indiana University Bloomington in the USA, said: "Die berichteten Nebenwirkungen entsprechen meinen Erwartungen bei einem Breitspektrum-Cannabisextrakt." The U.S. Food and Drug Administration has granted VER-01 the so-called "Breakthrough Therapy Designation." "Die FDA geht auf Basis der Studiendaten davon aus, dass das Arzneimittel das Potenzial habe, herkömmlichen Therapien überlegen sein… Daraus könnte ein beschleunigtes Zulassungsverfahren folgen," according to reports. The German broadcast about the drug aired on Deutschlandfunk on 11 June 2026. ## Expert skepticism on clinical relevance Not all experts are convinced. Ulrike Bingel, head of university pain medicine and of the Clinical Neurosciences and Translational Pain Research working group at University Hospital Essen, cautioned: "Eine statistische Signifikanz sei nicht mit klinischer Relevanz gleichzusetzen. Dafür seien die Stärken der Schmerzlinderung in den verschiedenen Subgruppen der Studienteilnehmenden zu unterschiedlich." Bingel added: "Einen Paradigmenwechsel in der Behandlung von chronischen Rückenschmerzen leitet die aus meiner Sicht aber nicht ein." She does not view the VER-01 study as initiating a paradigm shift in the treatment of chronic back pain, underscoring ongoing disagreement about how meaningful the new option will be in everyday clinical practice. EU property prices rose 53 percent between 2015 and 2024, while rents climbed nearly 17 percent in the same period, according to figures reported in the same broadcast segment, providing broader context for the cost pressures European patients face when seeking treatment.

Cannabis-based drug VER-01 approved in Germany and Austria for neuropathic back pain

Study data and the placebo question

Side effects and U.S. regulatory signal

Expert skepticism on clinical relevance

Questions & Answers