Tetra Bio-Pharma (TSXV:TBP; OTCQB:TBPMF) announced it received a No Objection Letter (NOL) from Health Canada, for its clinical trial of their PPP001 prescription smokable dried cannabis product candidate.
As quoted in the press release:
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 on the market aimed at treating breakthrough pain in cancer patients. The advanced cancer pain market is a $2.4B market1; this is a significant and important opportunity for the Company as our drug PPP001 has the potential to help reduce the reliance on opioids for the management of severe pain.”