Biodata, the medical science research subsidiary of JSE-listed Labat Africa, is the first South African company to receive Pharma-Ethics Independent Research Committee approval to conduct an observational research trial, which aims to uncover the opportunity to replace opioids with medical cannabis in the management of chronic pain.
This approval, which is granted in compliance with the guidelines for Good Practice in the Conduct of Clinicals Trials in Human Participants in South Africa (200), ICH Harmonised Tripartite Guidelines EC, is particularly significant as Biodata’s new venture will be one of the first medical cannabis observational trials in the country.
Dr Shiksha Gallow, medical director and CEO at Biodata and the principal investigator of the study, says that while the South African Health Products Regulatory Authority (SAHPRA) does not yet have any official cannabis-containing medicines approved for pain relief, “anecdotal evidence and preliminary studies point toward its potential to be highly effective in pain management, and, potentially, replacing opioids for pain management”.
“Chronic pain is defined as pain, acute or otherwise, that lingers for longer than six months, and can be categorised as visceral, somatic and neurogenic. Given the broad spectrum, a wide range of treatments exists, from over the counter drugs to opiates such as morphine, oxycodone or codeine, which instruct the body’s natural opioid receptors to prevent the nerves responsible for pain from signalling,” said Gallow.
Brian Van Rooyen, Labat Africa Group CEO, notes that while opiates can be highly effective in pain management, over time, the body will develop a tolerance, meaning the dose needs to be systematically increased to bring relief. This, in turn, can lead to dependance. “In addition, opiates are associated with a plethora of side effects.
“With the global increase in opiate addiction, the research will be focused on establishing a safer alternative to treating pain. Biodata, is currently well-positioned to start a formalised clinical trial for the future,” says Van Rooyen.
Gallow has been involved in many reputable trials funded by USAID and the Bill and Melinda Gates Foundation, such as the IAVI HIV vaccine study, PreP study, FACTS study and the H3 Africa Biorepository study at Wits Health Consortium.
This Labat backed-and-sponsored research study, which utilises a unique crowdfunding model and complies with the Ethics Standards for Clinical Research, as well as the Declaration of Helsinki guidelines, seeks to help practitioners understand the effects of cannabinoids for pain management and stress-related disorders.
Studying the effect of both the cannabis flower and oil, the trial will see 1,000 human participants recruited online and/or via three physical sites. Research participants can be onboarded via the Labat-owned Cannafrica Retail Stores, in various provinces, and other approved sites that comply with the stringent criteria set out by the Pharma Ethics protocols. Research participants are also able to link to the observational study via www.biodataresearch.co.za. “Medicinal cannabis patients’ pain management will be observed and documented, while side effects and any drug interactions will also be noted,” said Gallow.
Labat believes the study will firmly position Labat Africa at the forefront of the South African medical cannabis industry, with a strong focus on value creation in the economy.
“This research on cannabinoids as an alternative to opioids is a significant enhancement to our nutraceutical and pharmaceutical offerings, and will no doubt be of enormous value to both patients and practitioners alike. We are extremely excited about the potential cannabis wields in addressing chronic pain and alleviating patients’ suffering, effectively and safely,” said Van Rooyen.
Issued by Labat Africa