Ms. Natalie Leroux reports
TETRA BIO-PHARMA PROVIDES AN UPDATE ON ITS U.S. REBORN1 CLINICAL TRIAL
Tetra Bio-Pharma Inc. has shipped the investigational new drug, Qixleef, to the United States for the initiation of the Reborn1 study. The company has completed the manufacturing of Qixleef and has received the cannabis export permit from Health Canada. Reborn1 will investigate cannabis as an alternative to morphine sulphate immediate release in the management of breakthrough pain. Qixleef is a botanical drug product with a fixed ratio of THC and CBD and is inhaled through a vaporizer.
"We are committed to the fight against the opioid crisis. That is why since the authorization of the clinical trial by the FDA in late January, 2021, Tetra has worked hard to prepare Qixleef for clinical testing. We are on track to initiate this phase 2 proof-of-concept trial designed to demonstrate that Qixleef can provide pain relief faster than an immediate-release oral morphine," said Dr. Guy Chamberland, chief executive officer and chief risk officer of Tetra Bio-Pharma.
Reborn1 is a 10-week open-label randomized study to evaluate the effect 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, which 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. They occur with a frequency of 1.5 to six times per day and the majority are moderate to severe in intensity (Portenoy and Hagen 1990; Portenoy et al. 1999; Davies et al. 2011). It significantly affects the quality of life of patients with cancer and their ability to function normally (Zeppetella and Davies 2013).
About Tetra Bio-Pharma Inc.
Tetra Bio-Pharma is a leader in cannabinoid-derived drug discovery and development with a FDA- and a Health Canada-cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their health care providers. Its 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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