Tetra Bio-Pharma Inc (TSX:TBP) (OTCQB:TBPMF) (FRA:JAM1), a leader in cannabinoid-derived drug discovery and development, has submitted a request to the Malta Medicines Authority for a Scientific Opinion on its investigational new drug (IND) QIXLEEF for the company’s clinical trial programs.
The company said the request includes guidance on the REBORN2 trial to be performed in Europe.
QIXLEEF is a botanical drug product with a "fixed ratio" of THC and CBD and is inhaled through a vaporizer.
READ: Tetra ships inhaled cannabis drug QIKLEEF to US ahead of opioid comparison study in patients with breakthrough cancer pain
"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,” said CEO Guy Chamberland in a statement.
“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.”
Tetra said the REBORN2 trial is a seven-week randomized double-blind, placebo-controlled, dose-ranging study to evaluate the effect of three strengths of inhaled QIXLEEF compared to morphine sulfate immediate release (MSIR) to improve the 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 6 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.
Contact the author: patrick@proactiveinvestors.com
Follow him on Twitter @PatrickMGraham