TBPMF - Tetra Bio-Pharma accelerates REBORN1 trial with approved amendments for oral opioids

Tetra Bio-Pharma (TBPMF) announces that the Central Ethics Committee has approved the proposed protocol modifications allowing additional immediate release oral opioids to be used as comparators in the REBORN1 study.Expanding to three immediate release oral opioids will allow for the acceleration of patient enrolment in the REBORN1 trial. The Phase 2 study is against an opioid treatment in the management of short and frequent episodes of incapacitating pain requesting immediate release opioid treatment in cancer patients.The initial protocol was assessing a direct safety and efficacy comparison between QIXLEEF and oral morphine sulfate on the onset of pain relief in this population.The approved amended protocol opens the recruitment to cancer patients with breakthrough pain who are treated with either oral morphine sulfate immediate release, oral hydromorphone immediate release, or oral oxycodone immediate release.

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Tetra Bio-Pharma accelerates REBORN1 trial with approved amendments for oral opioids