Tetra Bio-Pharma Inc (TSE:TBP) (OTCQB:TBPMF) (FRA:JAM1) said it is accelerating its REBORN1 trial of its proprietary cannabinoid-based drug candidate QIXLEEF after receiving approval allowing the study to compare three other immediate release oral opioids.
The pharmaceutical company told investors that the Central Ethics Committee approved the proposed protocol modifications to REBORN1, a head-to-head Phase 2 study looking at opioid treatment to manage breakthrough pain in people with cancer.
Initially, the study was a direct safety and efficacy comparison between QIXLEEF and oral morphine sulfate immediate release, but the amended protocol introduces oral morphine sulfate immediate release, oral hydromorphone immediate release, or oral oxycodone immediate release as well.
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Tetra Bio told shareholders that the amendment “will allow the company to demonstrate the potential efficacy of QIXLEEF against a class of immediate relief oral opioids” and implemented upon approval of the federal Drug Enforcement Administration (DEA).
Tetra Bio’s CEO Guy Chamberland said the amendment “will facilitate the recruitment of patients who can benefit from QIXLEEF to treat their breakthrough pain,” because it widens the pool of qualified patients.
“Once the Schedule I license is approved, a process that usually takes a couple of weeks, the amended protocol will enhance the recruitment rate, thereby accelerating the study conduct. The approval by the DEA is a formality as the amendment does not modify the amount of controlled substance at the clinical site.”
QIXLEEF is an inhaled proprietary drug formulation that has a fixed ratio of THC and CBD. The medication is inhaled through a Class II medical vaporizer.
Chamberland added that the company “is in the business of providing the evidence which would see QIXLEEF become an alternative prescription therapy to opioids.”
“Further, there have been numerous news reports recently of drug makers exiting the opioid business, however for patients suffering from uncontrolled pain, this news does not provide them with an alternative to alleviate their pain,” the CEO said.
Ottawa-based Tetra Bio runs an FDA- and a Health Canada-cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers.
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