Tetra Bio-Pharma Inc (TSE:TBP) (OTCQB:TBPMF) (FRA:JAM1) said it has shipped its investigational new drug, QIXLEEF, to the US to initiate the planned REBORN1 study of patients with breakthrough cancer pain.
REBORN1 will evaluate cannabis as an alternative to morphine sulfate immediate release (MSIR), an opioid, in the management of breakthrough pain. Breakthrough pain refers to sudden intense increases or flare-ups of pain that generally last for a short period.
The company has completed the manufacturing of QIXLEEF and received the necessary cannabis export permit from Health Canada. QIXLEEF is a botanical drug product with a fixed ratio of THC and CBD that is inhaled through a vaporizer.
“We are committed to the fight against the opioid crisis,” Tetra Bio-Pharma CEO Guy Chamberland said in a statement. “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.”
The time to peak intensity of a breakthrough pain episode ranges from 3 to 15 minutes with a duration of 30 to 60 minutes, the company said. Episodes occur with a frequency of 1.5 to 6 times per day, and the majority are moderate to severe in intensity. Breakthrough pain significantly affects the quality of life of patients with cancer and their ability to function normally.
Contact Andrew Kessel at [email protected]
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Story by ProactiveInvestors
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