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European Biopharmaceutical Review

Editors Letter

Cannabis and its potential for medicinal use has made press headlines again recently; a young boy from the UK with a rare form of epilepsy who appeared to respond well to an experimental cannabis-based treatment in the Netherlands has triggered a consideration for a formal clinical trial in the UK to more fully investigate its potential in this patient. An often cited and significant body of anecdotal evidence exists that suggests cannabis-based products have benefits in epilepsy and a range of other medical conditions including the control of pain in cancer patients, management of symptoms in multiple sclerosis, etc – the common thread being neurological disorders. In 2017, an 11-year-old boy was allowed access to prescribed cannabis oil in the UK for life-threatening severe epilepsy and the clinical benefit to this young patient undoubtedly sets something of a precedent for its investigation in the six-year-old with a rarer form of epilepsy.

What will the impact for the biopharmaceutical industry be if and when large clinical trials begin for products based on this potent, naturally derived product and its subsequent (potentially) introduction to clinical practice? Its production, regulation, and control (quality, legal, and otherwise) will, no doubt, throw up new and unique challenges. However, if the end result benefits patients with safe medicinal products based on cannabis, then these will undoubtedly be worthwhilechallenges to tackle and overcome.

Migraine is one of the neurological disorders for which cannabis has been reported as having clinical advantage, although, as with epilepsy, this is yet to be confirmed by larger clinical studies. Migraine is a complex condition, and, despite being the most common debilitating neurological disease, Professor Dr Uwe Reuter at Charité Universitätsmedizin explains that therapy options have not advanced to any significant degree until recently (page 18). Thanks to progress in better understanding migraine pathophysiology, new approaches are tackling migraine and specifically the application of Onabotulinum toxin A that reduces plasma levels of calcitonin gene-related peptide (CGRP) and the now advanced clinical development of biological approaches; antibodies against the CGRP receptor (Erenumab) and ligand (galcanezumab, fremanezumab, and eptinezumab) could represent major breakthroughs in migraine treatment and help significant numbers of future patients.

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Dr Deborah O’Neil, Chief Executive and Scientific Officer, NovaBiotics Ltd
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Dr Deborah O'Neil
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