Cannabis to be Assessed as an Alternative to Fentanyl in Pivotal Clinical Trial
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Tetra Bio-Pharma has announced 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.
“Patients suffering from breakthrough pain require fast relief. Overdosing from fentanyl may occur in patients that exceed the recommended dosage in the hope of obtaining a more rapid relief. The development of a THC-based alternative would help provide a safer option to these patients and help prevent overdosing on fentanyl,” said Dr. Antonio Vigano, an Attending Physician at the Supportive and Palliative Care Division, McGill University Health Centre, an Associate Professor in the department of oncology, McGill University and the Research Director of Santé Cannabis where he is a Principal Investigator in a Phase 3 clinical trial for pain associated with advanced cancer, in addition to a phase 2 trial for chronic pain. “PPP001 has the potential to become the long-awaited alternative to opioids for the management of breakthrough pain in cancer patients. Through this trial we are going to gather more evidence-based data on the safety, efficacy and ease of administration of inhaled cannabinoids as the complementary therapy of choice for cancer-related pain,” said Dr. Vigano.
In Canada, the opioid crisis is serious and growing, and imposes devastating effects on families and communities. From January to September 2017, there were at least 2,923 apparent opioid-related deaths of which 92% were accidental. While males make up 76% of these fatalities, the highest percentage (28%) occurred among individuals between the ages of 30 and 39 years. I From January to September 2017, 72% of accidental apparent opioid-related deaths involved fentanyl or fentanyl analogs compared to 55% in 2016.
“Our rich cannabinoid-derived product pipeline has the potential to play a major role in opioid sparing, thus addressing a societal issue of critical proportion,“ said Guy Chamberland, Interim CEO and Chief of Scientific Affairs at Tetra Bio-Pharma. In addition, the R&D team is in discussions with Health Canada to take PPP001 into other therapeutic indications including fibromyalgia. In taking on new therapeutic indications for PPP001 we can, if successful, significantly increase the potential market as well shareholder value,” said Mr. Chamberland.