Tetra Bio Pharma Inc (TBPMQ)

[Emergcy]

announced today 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 (3) immediate-release oral opioids will allow for the acceleration of patient enrollment in the REBORN1© trial. The REBORN1© trial is a head-to-head phase 2 study against an opioid treatment in the management of short and frequent episodes of incapacitating pain (breakthrough pain) requesting immediate-release opioid treatment in patients living with cancer.


Why should the Ethic committee approve such change soon after the start of a phase 2 trial? I believe the reasons are as follows:

1) Ethics Committee has indications it might work; no risk but high chance of success
2) Soon pain control will unmet medical need

I might be wrong, but a good reason to stay long!