Today Tetra Bio-Pharma will present key findings from Phase 1 and Phase 2 cancer investigational trials with cannabinoids at the FDA hearing.
The Food and Drug Administration (FDA) hearing will be given scientific data from Tetra Bio-Pharma in Silver Spring, Maryland from their cancer investigational trials with cannabinoids.
Tetra Bio-Pharma’s CEO and CSO, Dr Guy Chamberland, commented: “The ground-breaking research that Tetra has and continues to advance is critical in adding to the scientific safety and efficacy data that regulators like the FDA, Health Canada and the European Medical Authority are looking for.”
Chamberland added: “Tetra is clearly seen as a world-class leader in conducting robust clinical studies, namely SERENITY© (Phase 3 in advanced cancer pain), REBORN© (phase 2 in breakthrough pain), OPIOSPARE© (Phase 2 to document opioid sparing effect) and others with cannabinoid-derived products to address unmet medical needs. We are privileged to share our insights and add to the body of evidence.”
The FDA Hearing
The aim of the hearing is to gather scientific information about cannabis and cannabis-derived compounds to inform the FDA’s regulatory oversight of related products. According to Tetra Bio-Pharma, “this hearing is particularly important considering the passage of the Agriculture Improvement Act of 2018, Public Law 115-334 (so called Farm Bill), which, among other things, removed the plant Cannabis sativa L. or “hemp” from the Controlled Substances Act.”
Tetra’s presentation will be made by Rola Mazloum, Director of Regulatory Affairs and will include, but is not limited to:
- The demonstration that inhalation via smoke or vapour achieves significantly superior delivery to the patient than the oral or sublingual routes and the oral route with capsules achieves less absorption than that of sublingual delivery
- A comparison of side effects when given single doses versus repeat daily dosing
- A comparison of smoked versus vaped product
- Pertinent safety findings from the Phase 1 trials
- Data that suggests a mechanism of tolerance to side effects.
Source: Tetra Bio-Pharma