Germany Approves First Standardised Cannabis Painkiller as Alternative to Opioids
16.06.2026 - 15:17:16 | boerse-global.de
As Germany grapples with roughly 20 million opioid prescriptions a year, a new cannabis-based drug has won regulatory approval in what the manufacturer hopes will offer a safer path for chronic back-pain sufferers. The Federal Institute for Drugs and Medical Devices (BfArM) cleared Exilby on 9 June 2026, making it the first finished cannabis medicine in Europe specifically designed for chronic back pain with a neuropathic component.
Vertanical, the privately owned company behind Exilby, plans to launch the product in Germany and Austria in September 2026, though the timeline depends on price negotiations with health insurers.
Challenge to Tramadol and Fentanyl
Vertanical founder Clemens Fischer aims to position Exilby as a non-addictive substitute for conventional opioids such as tramadol and fentanyl, which can cause dependency and gastrointestinal side effects. The new drug showed no potential for dependence in clinical trials, according to data published in Nature Medicine.
The company tested extracts from 500 different cannabis plants before settling on the formulation. Vertanical remains fully owned by Fischer and Madlena Hohlefelder, with no external investors.
Clinical Evidence and Side-Effects
Approval rests on a phase-3 study involving 820 participants. Patients reported an average pain reduction of 1.9 points on the rating scale, compared with 1.4 points in the placebo group. Among the specific target population, the benefit widened to 1.6 points. The study demonstrated significant pain relief lasting more than a year.
However, 17 percent of participants discontinued treatment due to adverse effects. Vertanical is already investigating additional applications for Exilby, including polyneuropathy and osteoarthritis.
US Regulators Grant Breakthrough Label
On 18 May 2026, the US Food and Drug Administration awarded Exilby’s active ingredient “Breakthrough Therapy” status. A separate phase-3 trial is under way in the United States, with approval expected in 2028 or 2029.
Political Tensions Over Cannabis Flowers
While finished drugs like Exilby enter the market, Germany’s parliament debated on 12 June whether to stop covering raw cannabis flowers under statutory health insurance. The proposal would maintain reimbursement for extracts and finished medicines but cut spending on flowers, which the government estimates could save roughly €130 million in 2027.
Industry groups oppose the plan, arguing that cannabis flowers are a cheaper therapeutic option compared with more expensive finished products.
Broader Pain-Therapy Developments
From 1 July 2026, liposuction for lipoedema will become a statutory benefit for all severity grades, provided conservative treatment over six months has failed. Separately, XBiotech has launched a phase-2 trial of the antibody vilamakitug for axial spondyloarthritis.
The German Society for Pain Medicine has announced further research. A study involving at least 1,500 participants on chronic back and osteoarthritis pain begins in June, followed by a fibromyalgia investigation in September.
