Tetra Bio-Pharma (TSXV:TBP) announced Health Canada approved its protocol for a clinical trial set to determine the use of PPP001 as an alternative in the management of cancer pain compared to opioid fentanyl products.
As quoted in the press release:
The clinical trial will be conducted by Montreal-based Santé Cannabis, a medical clinic and contract research organization specialized in clinical research for cannabis – based therapies.
The trial will assess the time-to-relief in patients suffering from breakthrough cancer pain. Based on its clinical data, Tetra believes that the pharmacodynamic properties of PPP001 may provide a novel faster acting alternative to the opioid fentanyl. In addition, the time-to-maximal plasma concentrations of THC suggest that PPP001 will provide rapid relief to the patient’s suffering. As a prescription drug with a Drug Identification Number (DIN) PPP001 will be eligible for insurance coverage, making the cannabis-based medication accessible in pharmacies thereby providing much easier access.
“Medical cannabis may help reduce the use of drugs like fentanyl for treating breakthrough and chronic pain. However, unrefuted scientific data on its safety and effectiveness that will satisfy regulators, professional groups and insurers is what’s missing,” said Dr. Guy Chamberland, Interim CEO and Chief Scientific Officer of Tetra Bio-Pharma. “Tetra is in the business of providing that evidence which would see our drug PPP001 become a complementary prescription therapy. We’ve taken a pharmaceutical pathway of drug development involving collaborative dialogue with Health Canada and the FDA to bring cannabis and cannabinoid products to market so that physicians, who have been hesitant to recommend it, will have a new, trusted therapeutic option for their patients.”