Pain relief: New cannabis drug coming to Austria

A new cannabis-derived medication, Exilby, is set to launch in Germany and Austria in September, offering a potential alternative for patients suffering from chronic lower back pain with neuropathic components. Vertanical GmbH, the developer, has received regulatory approval for the drug in both countries and is also pursuing an expedited review process in the United States, with a potential market entry there in 2028 or 2029.

Vertanical founder Clemens Fischer positions Exilby as a safer alternative in a painkiller market heavily impacted by the opioid crisis, particularly in the U.S. He stated his primary goal is to replace opiates, which have been linked to hundreds of thousands of deaths. Clinical studies reportedly show Exilby performing better than a placebo, causing fewer gastrointestinal issues than opioids like tramadol and fentanyl, and showing no signs of addiction or withdrawal in tested patients.

The medication is derived from a standardized cannabis extract, developed after analyzing approximately 500 cannabis plants to identify a specific genetic profile. This standardization, with fixed proportions of THC, CBD, and other active compounds, ensures reproducible quality and dosage, a critical factor for regulatory approval and a key differentiator from many other cannabis-based preparations whose composition can vary significantly.

Vertanical is not alone in developing alternatives to established painkillers. Vertex Pharmaceuticals' Journavx entered the U.S. market last year as the first new painkiller type in over two decades. However, the medical assessment of such treatments remains nuanced. Pain specialist Winfried Häuser, involved in one of Exilby's studies, noted that not all patients will benefit, but he could envision preferring Exilby over other available cannabis-based medicines in Germany, depending on final costs.

Beyond Germany and Austria, Vertanical is also preparing for market approval in Great Britain, indicating a broader European strategy before its anticipated U.S. market entry.