Tetra Bio-Pharma (CNSX:TBP) has announced that the Therapeutic Products Directorate of Health Canada approved its Phase I clinical study of PPP001 covering smoked cannabis for pain management in cancer and AIDS patients.
As quoted in the press release:
The announcement was followed one week later by the beginning of the trial, as Tetra was clearly ready to get going. The trial is a first study approved that could eventually lead to approval of the product as a prescription drug. The study assesses single and 7-day multiple daily ascending doses of smoked cannabis on the cognitive function in healthy adults.
It is the first development program aiming to obtain prescription drug approval and government provided insurance coverage for medical marijuana patients. If successful, the approval would set Tetra apart from all other medical marijuana providers who cannot get government provided insurance coverage and reimbursement for their patients. This could prove to be a major value driver for the company, as the lack of reimbursement is a serious obstacle for many patients seeking treatment.
Tetra Bio-Pharma also recently completed a pre-IND meeting with the United States Food & Drug Administration (“FDA”) Division of Anesthesia, Analgesia, and Addiction Products (“DAAAP”) Center for Drug Evaluation and Research (“CDER”) in late-January. During the meeting, the FDA provided guidance on the design of Phase I clinical trials and the overall program, while validating that the company was on the right track.