Tetra Bio-Pharma (OTCQB:TBPMF) announces that it has received a No Objection Letter from the Therapeutic Products Directorate Health Canada to its Clinical trial application for PPP001 prescription smokable dried cannabis product.
Phase 3 clinical trial of PPP001 is the first registration trial in the world for smokable cannabinoid-based drug. This trial, enrolling 946 subjects will evaluate the therapeutic benefits of a cannabinoid prescription drug in improving quality of life and treating pain in terminal cancer patients.
If conclusive, Tetra will submit a filing for a Drug Identification Number to Health Canada in 2019. If approved, PPP001 is expected to launch in Canada by Q1, 2020 and in the US by Q3, 2020.
PPP001 aims to be the first smokable marihuana for advanced cancer pain under prescription. PPP001 is a unique blend of 3 strains of standardized dried cannabis, creating a drug substance with