Tetra Bio-Pharma (TSXV:TBP) announced it will investigate the use of PPP001 as an alternative to fentanyl for the management of breakthrough pain.
As quoted in the press release:
Tetra Bio-Pharma is pleased to announce that Santé Cannabis, the independently credentialed research organization they work with has finalized the clinical study protocol evaluation of PPP001, which will be the first time that cannabis is being compared to fentanyl in a clinical trial. The study protocol has received approval from the Independent Ethics Board (IRB Services) and was recently submitted for review to Health Canada. PPP001 will investigate cannabis as an alternative to fentanyl in the management of breakthrough pain. Santé Cannabis is a Quebec-based medical clinic specialized in clinical research and cannabis – based therapies.
Health Canada approved clinical trials completed by Tetra Bio-Pharma in 2017 and 2018 have led to a significantly improved understanding of the safety, pharmacokinetics and pharmacodynamics of PPP001 in the treatment of pain and suffering. The development of clinical research protocols to investigate the use of cannabis as an alternative to fentanyl followed Tetra’s meeting with the Therapeutic Products Directorate (TPD), Health Canada in early 2018. As a prescription drug, PPP001 will be eligible for insurance coverage.
The trial is designed to assess the time-to-relief in patients suffering from breakthrough pain. Based on its clinical data, Tetra believes that the pharmacodynamic properties of PPP001 may provide a novel alternative to fentanyl. In addition, the time-to-maximal plasma concentrations of THC suggests that PPP001 will provide rapid relief to the patient’s suffering.