Zelira Therapeutics Ltd (ASX:ZLD, OTCQB:ZLDAF)’s open-label dose-escalation trial results in chronic non-cancer pain patients have been published in the peer-reviewed journal Pain And Therapy.
The trial, undertaken by The St Vincent’s Hospital Melbourne (SVHM) research team led by the coordinating investigator Associate Professor Yvonne Bonomo in conjunction with Emyria Ltd (ASX:EMD), examined the pharmacokinetics, safety and tolerability of escalating doses of a medicinal cannabis product in patients with chronic non-cancer pain (CNCP).
The publication can be read here.
Publication of the trial in an international peer-reviewed journal is testament to Zelira’s commitment to work with world-class researchers undertaking research that is critical to the continued maturation of the medicinal cannabis industry as a pharmaceutical-grade treatment.
Other chronic non-cancer pain trials
Zelira Therapeutics managing director Dr Oludare Odumosu said: “The publication of these trial results is further testament of Zelira’s world-class pharmaceutical manufacturing and commitment to producing the highest quality, evidence-based cannabinoid medicines.
“In addition, Zelira has leveraged the knowledge gained from this work to support the development of the proprietary formulation which we have licensed to Levin Health and to inform the design of other chronic non-cancer pain trials.”
Joint commitment
Lead investigator and author, associate Professor Yvonne Bonomo, said: “We were very pleased to work with Zelira on this project which exemplifies our joint commitment to ensuring quality and safety in the implementation of medicinal cannabis use in the community."
Trial details
The results of the trial were announced on July 14, 2020.
In the trial, nine people with chronic non-cancer pain and an oral morphine equivalent daily dose (OMEDD) of ≥60mg were recruited.
The study provides important pharmacokinetic and safety data in a clinical population with multiple physical comorbidities and polypharmacy, who are often excluded from clinical trials.
Observed improvements in pain interference scores, mood and some sleep parameters suggest areas for further investigation under randomized controlled clinical trial conditions.
Pain and Therapy Journal
Pain And Therapy is an international, peer-reviewed journal dedicated to the publication of high-quality clinical research around the discovery, development and use of pain therapies and pain-related devices.
The journal is read by a global audience and assists in the dissemination of all scientifically and ethically sound research.