Germany approves first cannabis-based chronic pain medication Exilby

Yesterday 08:52

By: Dakir Madiha

Germany approves first cannabis-based chronic pain medication Exilby

A biopharmaceutical company has secured regulatory approval in Germany and Austria for a cannabis-derived oral treatment targeting chronic lower back pain with neuropathic features. The product, Exilby (VER-01), becomes the first cannabis-based medicine explicitly authorized for chronic pain management in these markets. The company plans to pursue additional approvals in the United Kingdom and across the European Union, with availability for patients expected in the autumn.

The approval follows two large phase 3 randomized clinical trials involving more than 1,200 participants. One placebo-controlled study with 820 patients showed that VER-01 reduced pain intensity by an average of 1.9 points on an 11-point scale after 12 weeks of treatment. The effect persisted over a 12-month follow-up period, indicating sustained symptom control in a condition often resistant to long-term therapeutic improvement.

A second head-to-head trial conducted across several European countries compared VER-01 directly with opioid-based therapy in 384 patients. The results indicated stronger pain reduction and improved gastrointestinal tolerability for the cannabis-derived treatment. Researchers reported no evidence of dependence or withdrawal symptoms in either study, a finding that positions the drug as a potential alternative in long-term pain management strategies where opioid risks remain a major concern.

The company also confirmed progress in the United States regulatory pathway, where the treatment has received breakthrough therapy designation from the Food and Drug Administration. This status supports accelerated development for therapies addressing serious conditions. A further phase 3 trial is underway in the United States, with initial data expected in 2027 and a planned submission for market authorization in 2028. The treatment is delivered orally as liquid drops derived from a proprietary Cannabis sativa strain containing multiple bioactive compounds, with company leadership stating that it offers effective pain relief without addictive potential.