TBPMF - Tetra Bio-Pharma gets FDA greenlight for QIXLEEF Reborn1 trial

Tetra Bio-Pharma ([[TBPMF]] +9.8%) announces that the U.S. FDA has cleared its Investigational New Drug application to initiate its QIXLEEF Reborn1 clinical trial in cancer patients with breakthrough pain.Reborn1 is a 10-week open-label randomized study to evaluate the effect of inhaled QIXLEEF compared to morphine sulfate immediate release ((MSIR)) to improve fast onset of pain relief of breakthrough cancer pain.The study's primary endpoint is the time weighted Sum of Pain Intensity Differences ((SPID)) from pre-dose to 30 minutes (SPID30) after the first inhalation or after taking MSIR.

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Tetra Bio-Pharma gets FDA greenlight for QIXLEEF Reborn1 trial