Tetra Bio-Pharma (TBP.T) has shipped Qixleef, its investigational new drug, to the United States for initiation of the REBORN1 study. The REBORN1 study will investigate cannabis as an alternative for the management of breakthrough pain (BTP).
“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.
Tetra Bio-Pharma’s Qixleef is intended to serve as an alternative to morphine sulfate immediate release (MSIR) which is predominantly used to treat breakthrough pain of patients. Breakthrough pain refers to the pain that may occur in patients who already have chronic pain as a result of various ailments such as arthritis, cancer, and fibromyalgia. With this in mind, breakthrough cancer pain (BTcP) refers to the high-intensity and short-duration pain episodes that significantly impact the lives of patients with cancer. These painful and inconvenient episodes happen frequently, occurring between 1 to 6 times per day.
Qixleef is a botanical drug product with a fixed ratio of THC and CBD and is inhaled through a vaporizer compared to MSIR which is ingested orally. In addition to completing the manufacturing of Qixleef, Tetra Bio-Pharma has received its cannabis export permit from Health Canada. The REBORN1 study is a 10-week-open-label randomized study that will evaluate the effects of Qixleef against MSIR to assist in alleviating BTcP. Ultimately, Tetra Bio-Pharma hopes to provide a safe and effective means of combating BTcP.
In doing so, the Company is committed to fighting against the current opioid crisis which claims 136 lives per day according to Centers for Disease Control and Prevention (CDC). Moreover, prescription opioids accounted for over 28% of all opioid deaths in 2019. With this in mind, the predominant use of morphine has fueled the ongoing opioid epidemic. Tetra Bio-Pharma is looking to normalize the presence of cannabis in the medical sector while also minimizing the use of morphine in breakthrough pain treatments. Tetra Bio-Pharma’s involvement in the REBORN1 study marks a significant milestone for the Company as a biopharma industry leader. Tetra Bio-Pharma will be worth keeping an eye on during the course of REBORN1’s 10-week study.
Tetra Bio-Pharma’s share price opened at $0.28, up from a previous close of $0.26. The Company’s share price reached a high of $0.32 at 2:00PM ET and currently sits at $0.32. Tetra Bio-Pharma’s stock is up 23.08% indicating significant change following the news.