As quoted in the press release:
Natural health products and OTC medications
The authorization from the Office of Controlled Substances marks the initiation of the treatment phase of the Phase 2 clinical trial that will be used to support Product License Applications post legalization. Tetra is performing this clinical study to obtain safety and efficacy data to support modern claims for the use of encapsulated cannabis oils in the treatment of chronic pain. Tetra’s program is designed to build a leading position in the development and commercialization of cannabis-based natural health products. Tetra’s products are being developed to be compliant with standards expected for pharmaceutical products which will be supported by scientific and clinical evidence.
PPP005 Phase 1 Clinical trial
Phase 1 clinical trial to assess safety, tolerability and pharmacokinetics of single and multiple dose of encapsulated cannabis oil (10 mg THC with 10 mg CBD) will be completed soon. “This study will provide cardiovascular safety data to ensure that the oil formulations can be safely used by consumers. The pharmacokinetic data will provide the data required to define the frequency of dosing needed to avoid inappropriate use that could lead to accumulation of cannabinoids in the body,” said Dr. Guy Chamberland, M.Sc., Ph.D., interim CEO and Chief Scientific Officer.