Releaf Pharmaceuticals Launches a Cannabis Clinical Trial in South Africa

Medical cannabis (dagga) is legal in South Africa (SA) and is regulated by the South African Health Products Regulatory Authority (SAHPRA). So far, no cannabis-based drug has been approved for the treatment of any medical condition. 

Releaf Pharmaceuticals, a leading SA based pharmaceutical company has partnered with the Cannabis Research Institute of South Africa (CRI) to investigate the role of opioids in treating opioid addiction. Releaf Pharmaceuticals  is registered under the Complementary and Alternative Medicines (CAMs) category and offers products that meet CAMs/SAHPRA requirements.

CRI is the sponsor of this observational clinical trial  that will run for a year and investigate how patients with chronic pain respond to medical cannabis. Medical cannabis patients attending Releaf Pharmaceuitcals e-clinics will receive free medical cannabis during the study period.  The CRI has stated that the objective of the study is to provide credible and verifiable data to facilitate the regulation of medicinal cannabis in South Africa. Dr Shiksha Gallow, a cannabis clinician is leading the study and working alongside a team of highly skilled physicians in the medical cannabis industry.

“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 towards its potential to be highly effective in pain management,” said Gallow.

Chronic pain is defined as pain that lasts for a duration exceeding three months. It is often treated with non-steroidal anti-inflammatory drugs (NSAIDS) and opioids. While opioids may offer significant relief from pain, they are associated with a number of adverse events. Consequently, there has been a quest for safer and effective alternatives to steroids. This new study will compare the effectiveness versus safety of medical cannabis in treating chronic pain.

Cannabis contains over 500 bioactive molecules mostly composed of cannabinoids and terpenes. Studies have shown that delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) offer significant relief from pain. Some studies have shown that terpenes boost the therapeutic effects of cannabinoids through what is now famously referred to as the entourage mechanism.

South Africa (SA) legalized cannabis (dagaa) for private use in 2018. Medical cannabis products can be prescribed for any condition as a physician deems suitable. Patients can also apply for medical cannabis treatment through medical practitioners who are licensed by SAHPRA who must make an online application. Medical cannabis can be purchased from pharmacies that have been registered by the South African Pharmacy Council (SAPC). SA is among the few countries in Africa that have legalized some form of cannabis. The rest include Malawi, Uganda, Zimbabwe, Lesotho, and Zambia.