After more than a decade in development, a full-spectrum cannabis extract has received market authorisation in Germany and Austria, with UK approval expected by the end of the year.
Developed by German biopharmaceutical company Vertanical, Exilby® (also known as VER-01) will now be prescribed for the treatment of chronic lower back pain with a neuropathic component, and is expected to be eligible for reimbursement in line with national processes.
It comes following two randomised, controlled Phase 3 trials completed last year, in which the drug was found to reduce pain more effectively than opioids and with greater tolerability.
The company told Cannabis Health that the number of patients who may be eligible for the treatment will ‘depend on several factors, including clinical prescribing decisions, market access, and reimbursement processes’.
Chronic pain remains one of the largest unmet needs in healthcare, affecting more than one billion people worldwide. Despite its major medical, social, and economic burden, innovation in treatment has substantially lagged behind other major disease areas, with many patients still reliant on opioids despite well-documented risks and side effects.
Vertanical’s founder, Dr Clemens Fischer, has invested more than $250m of his own fortune into developing Exilby to address what he sees as ‘one of the largest unresolved challenges in medicine’.
“His view was that a rigorously developed, standardised cannabinoid-based medicine, supported by Phase 3 clinical evidence, could represent a genuinely new class of treatment for chronic pain,” a representative for the company told Cannabis Health.
In clinical trials completed last year, the drug demonstrated significant reductions in pain compared with placebo, with patients also experiencing improvements in sleep disturbances and physical function. A second, Phase 3 comparator study demonstrated greater pain reduction and better gastrointestinal tolerability compared with opioids.
Across the clinical program, VER-01 was generally well tolerated, with no evidence of dependence or withdrawal symptoms observed.
“The marketing authorization of Exilby in selected European countries is far more than a regulatory milestone for our company,” Dr Fischer commented.
“It demonstrates that meaningful therapeutic innovation in chronic pain is possible. Patients have waited far too long for real progress, and we believe Exilby marks an important step toward changing how chronic pain is treated.”
Vertanical says it is now preparing a submission to the UK’s Medicines and Healthcare Regulatory Agency (MHRA) for later this year, with marketing authorisation targeted before the end of 2026.
According to the company, it has already been identified by the National Institute for Health and Care Excellence (NICE) health technology assessment pathway as a treatment that should undergo clinical and economic evaluation and is moving towards NHS availability.
“Commonly prescribed opioid medicines are generally available as generics and therefore tend to have a low acquisition cost,” a spokesperson said.
“For Exilby, the value case is based on its potential clinical profile rather than a direct medicine-cost comparison.”
Thy added: “NHS availability would remain subject to MHRA approval, NICE evaluation and the usual commissioning and access processes.”
Professor Roger Knaggs, Professor of Pain Management at the University of Nottingham and President of the British Pain Society, said chronic low back pain with a neuropathic component is “particularly difficult to treat” and “remains a major burden for too many patients in the UK”.
“The marketing authorization of Exilby® in Germany and Austria signals that meaningful innovation in chronic pain is possible,” he said.
“For patients with a neuropathic pain component, Exilby may represent an important breakthrough and a much-needed new direction in long-term pain management.”
The drug has also been granted Breakthrough Therapy Designation from the FDA, with clinical trials now expected to get underway in the US.
“For decades, patients with chronic pain have too often been forced to choose between insufficient relief and unacceptable risk,” Dr Fischer added.
“Our focus now is to move with urgency to bring this innovation to patients across all of Europe and the US.”
The post Cannabis-Based Drug Receives First European Market Approvals for Chronic Back Pain appeared first on Cannabis Health News.
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Developed by German biopharmaceutical company Vertanical, Exilby® (also known as VER-01) will now be prescribed for the treatment of chronic lower back pain with a neuropathic component, and is expected to be eligible for reimbursement in line with national processes.
It comes following two randomised, controlled Phase 3 trials completed last year, in which the drug was found to reduce pain more effectively than opioids and with greater tolerability.
The company told Cannabis Health that the number of patients who may be eligible for the treatment will ‘depend on several factors, including clinical prescribing decisions, market access, and reimbursement processes’.
A new class of treatment for chronic pain
Chronic pain remains one of the largest unmet needs in healthcare, affecting more than one billion people worldwide. Despite its major medical, social, and economic burden, innovation in treatment has substantially lagged behind other major disease areas, with many patients still reliant on opioids despite well-documented risks and side effects.
Vertanical’s founder, Dr Clemens Fischer, has invested more than $250m of his own fortune into developing Exilby to address what he sees as ‘one of the largest unresolved challenges in medicine’.
“His view was that a rigorously developed, standardised cannabinoid-based medicine, supported by Phase 3 clinical evidence, could represent a genuinely new class of treatment for chronic pain,” a representative for the company told Cannabis Health.
In clinical trials completed last year, the drug demonstrated significant reductions in pain compared with placebo, with patients also experiencing improvements in sleep disturbances and physical function. A second, Phase 3 comparator study demonstrated greater pain reduction and better gastrointestinal tolerability compared with opioids.
Across the clinical program, VER-01 was generally well tolerated, with no evidence of dependence or withdrawal symptoms observed.
“The marketing authorization of Exilby in selected European countries is far more than a regulatory milestone for our company,” Dr Fischer commented.
“It demonstrates that meaningful therapeutic innovation in chronic pain is possible. Patients have waited far too long for real progress, and we believe Exilby marks an important step toward changing how chronic pain is treated.”
Moving with urgency
Vertanical says it is now preparing a submission to the UK’s Medicines and Healthcare Regulatory Agency (MHRA) for later this year, with marketing authorisation targeted before the end of 2026.
According to the company, it has already been identified by the National Institute for Health and Care Excellence (NICE) health technology assessment pathway as a treatment that should undergo clinical and economic evaluation and is moving towards NHS availability.
“Commonly prescribed opioid medicines are generally available as generics and therefore tend to have a low acquisition cost,” a spokesperson said.
“For Exilby, the value case is based on its potential clinical profile rather than a direct medicine-cost comparison.”
Thy added: “NHS availability would remain subject to MHRA approval, NICE evaluation and the usual commissioning and access processes.”
Professor Roger Knaggs, Professor of Pain Management at the University of Nottingham and President of the British Pain Society, said chronic low back pain with a neuropathic component is “particularly difficult to treat” and “remains a major burden for too many patients in the UK”.
“The marketing authorization of Exilby® in Germany and Austria signals that meaningful innovation in chronic pain is possible,” he said.
“For patients with a neuropathic pain component, Exilby may represent an important breakthrough and a much-needed new direction in long-term pain management.”
The drug has also been granted Breakthrough Therapy Designation from the FDA, with clinical trials now expected to get underway in the US.
“For decades, patients with chronic pain have too often been forced to choose between insufficient relief and unacceptable risk,” Dr Fischer added.
“Our focus now is to move with urgency to bring this innovation to patients across all of Europe and the US.”
The post Cannabis-Based Drug Receives First European Market Approvals for Chronic Back Pain appeared first on Cannabis Health News.
Continue reading...
