Tetra Bio-Pharma receives Health Canada Phase 3 clinical trial approval for smokable dried cannabis prescription drug.
Tetra Bio-Pharma Inc., a cannabinoid-based drug development and discovery company, has received a No Objection Letter (NOL) from the Therapeutic Products Directorate (TPD) Health Canada to its clinical trial application (CTA) for the company’s PPP001 prescription smokable dried cannabis product.
Coinciding with World Cancer Day 2018, Tetra is now ready to initiate its Phase 3 clinical trial of PPP001 in terminal cancer patients, the first registration trial in the world for smokable cannabinoid-based drug. This trial is expected to be a landmark study, enrolling a total of 946 subjects, evaluating the therapeutic benefits of a cannabinoid prescription drug in improving quality of life and treating pain in terminal cancer patients.
“This is an especially significant and noteworthy milestone for the lead candidate in our product pipeline,” said Bernard Fortier, Tetra’s CEO, “as it positions Tetra to potentially be the first company with a Health Canada approved, cannabinoid-based drug