Mr. Guy Chamberland reports
TETRA BIO-PHARMA SUBMITS REQUEST FOR SCIENTIFIC ADVICE TO MALTA MEDICINES AUTHORITY
Tetra Bio-Pharma Inc. has submitted a request to the Malta Medicines Authority for a scientific opinion on its investigational new drug (IND), Qixleef, for Tetra's clinical trial programs. This request includes guidance on the Reborn2 trial to be performed in Europe. Qixleef is a botanical drug product with a fixed ratio of THC (tetrahydrocannabinol) and CBD (cannabidiol) and is inhaled through a vaporizer.
"Based on the speed of onset of the pharmacodynamic effects of Qixleef, Tetra has positioned this inhaled IND as a potential therapy for the rapid relief of severe acute pain, such as breakthrough pain. Patients require fast relief when suffering from excruciating pain, and we believe that the fast onset of Qixleef might be a viable alternative to opioids. We are seeking guidance from the Malta Medicines Authority on Tetra's clinical development program of Reborn2 as we plan for global commercialization of Qixleef," said Guy Chamberland, chief executive officer and chief regulatory officer of Tetra Bio-Pharma.
Reborn2 is a seven-week randomized double-blind, placebo-controlled, dose-ranging study to evaluate the effect of three strengths of inhaled Qixleef compared with morphine sulphate immediate release (MSIR) to improve fast onset of pain relief of breakthrough cancer pain (BTcP). BTcP is a rapid-onset, high-intensity and short-duration pain episode that takes place within stable background pain control. The time to peak intensity of an episode ranges from three to 15 minutes with a duration of 30 to 60 minutes. Episodes occur with a frequency of 1.5 to six times per day, and the majority are moderate to severe in intensity. BTcP significantly affects the quality of life of patients with cancer and their ability to function normally.
About Tetra Bio-Pharma Inc.
Tetra Bio-Pharma is a leader in cannabinoid-derived drug discovery and development with a Food and Drug Administration- and a Health Canada-cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their health care providers. The company's evidence-based scientific approach has enabled it to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation and oncology. With patients at the core of what the company does, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians and insurance companies.
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