Khiron Life Sciences is to present clinical evidence on the safety of its oral cannabis extracts at the annual meeting of the British Pain Society.
Cannabis derivatives have been authorised for medicinal use in many countries, but there is still little information about the safety of cannabis-based medicinal products (CBMPs) in real-life clinical practice.
However, a new study conducted by Khiron Life Sciences and presented at the annual meeting of the British Pain Society in Glasgow from 9-11 May, sheds some light on the safety profile of Khiron’s CBMPs in a large cohort of Peruvian patients.
The study analysed individual case reports of suspected adverse drug reactions related to oral cannabis extracts reported to Khiron’s pharmacovigilance system between March and October 2022.
All patients who received treatment with CBMPs during this period were included in the review, and all suspected adverse reactions associated with CBMPs were included.
The study found that only 12.7% of the 1,060 patients receiving treatment with CBMPS reported at least one adverse reaction.
Women reported significantly more adverse reactions than men, and most adverse reactions occurred in the first four weeks of treatment. The distribution of adverse reactions associated with each product was proportional to the frequency of prescription of the product, and no higher incidence was found in CBMPs containing THC.
This finding is particularly relevant for British doctors as these formulations [KHIRIOX 25/1 and KHIRIOX 12/14] are available in the UK as unlicensed medications.
The most frequently reported adverse reactions corresponded to nervous system disorders and gastrointestinal disorders, with dizziness, somnolence, and dry mouth being the preferred terms. Most adverse reactions (93 %) were rated as ‘mild’ in severity.
Overall, the study represents the first description of adverse reactions with CBMPs in a cohort of Peruvian patients in a real clinical setting and confirms the safety profile previously reported for this type of pharmaceutical preparations.
While more research is needed, these findings suggest that CBMPs may be a safe option for the treatment of various medical conditions, and their use could potentially benefit many patients worldwide.
Dr Ayman Eissa, pain specialist at Zerenia Clinics UK
Dr Ayman Eissa, the presenting author and pain specialist at Zerenia
Clinics UK commented: “Although there has been some concern about the safety of cannabis-based medicinal products, this study provides evidence that these products are generally well-tolerated in real-world clinical settings. Our findings suggest that the reported adverse reactions were mostly mild and occurred early during treatment. However, we should continue to monitor the safety of these products and educate patients and healthcare providers about the potential risks and benefits.”
Dr Guillermo Moreno-Sanz, global scientific director, Khiron Life Sciences
Dr Guillermo Moreno-Sanz, global scientific director at Khiron Life Sciences and main author of the study, added: “This study provides valuable information for prescribers who may be considering cannabis-based medicinal products as a treatment option for their patients. The low incidence of adverse reactions resonates with what reported by others in the UK and suggests that these products can be a safe and effective alternative for patients who have not responded to traditional treatments for conditions such as chronic pain or spasticity.
“With the increasing availability of CBMPs in many countries, it is important that healthcare providers have access to reliable information about their safety and efficacy. Our findings should encourage more prescribers to consider CBMPs as a potential treatment option for their patients.”
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