Vertanical's cannabis-based painkiller hits target in trials

A cannabis-derived drug developed by Germany's Vertanical has shown efficacy in phase 3 as a treatment for chronic pain, offering the prospect of an alternative to opioid drugs that carry the risk of dependency.

The VER-01 therapy – a cannabis extract that includes the full range of cannabinoid compounds, including low levels of THC – was effective as a treatment for chronic lower back pain in a pair of placebo-controlled trials, which enroled around 820 people, without serious side effects or any sign of addiction or abuse potential.

According to Vertanical, which said it has submitted the data for publication, VER-01 also achieved significant improvements in pain-related sleep disturbances and physical function in the studies, which were used to file for approval as a treatment for chronic lower back pain in Germany and Austria last year. A decision on those applications is due in July and – if approved – the drug will be sold under the Exilby brand name.

The Munich-based company's chief executive, Dr Clemens Fischer, said that pain patients around the world are "caught in a vicious cycle of pain, insomnia, limited mobility, and depression. VER-01 has the potential to successfully break this vicious cycle."

The data and filing are another positive development in the drive to find alternatives to opioids and alleviate the epidemic of addiction and overdose deaths that has taken hold in countries around the world, including the US, in recent years.

Earlier this year, Vertex Pharma achieved a milestone with the FDA approval of its NaV1.8 sodium channel inhibitor Journavx (suzetrigine) as a treatment for acute pain management, for example, after surgeries, although chronic pain is a much larger opportunity.

In a statement, Vertanical said more than 1.5 billion people worldwide suffer from chronic pain – making it more common than diabetes, cardiovascular disease, and cancer combined – and back pain is by far the most common form. Opioids only provide long-term relief for 30% of patients, it added.

"VER-01 could be a safer and more effective alternative for many chronic back pain patients who are inadequately treated with previously approved therapies," said Dr Philipp Müller-Schwefe, an investigator in Vertanical's study and director of the Göppingen Pain and Palliative Care Centre in Germany.

"It is a highly effective painkiller for chronic back pain, with a low risk of addiction, tolerance development, or respiratory depression compared to opiate analgesics—in my opinion, this is a true revolution in pain medicine," he added.

The company said it is now preparing to file for approval of VER-01 in other countries, including the wider EU, UK, and USA, and also plans to start additional clinical trials in other pain indications. If approved, it would be the first cannabinoid-based therapy for chronic low back pain.