Tetra Bio-Pharma Inc (TSE:TBP) (OTCQB:TBPMF) (FRA:JAM1) announced Friday that the US Food and Drug Administration (FDA) had cleared its investigational new drug application on its cancer painkiller QIXLEEF.
The approval means that the Ottawa-based company can now start a 10-week clinical trial in cancer patients with breakthrough pain.
QIXLEEF has a 'fixed ratio' of THC and CBD and is inhaled through a vaporizer. It is squarely aimed at providing respite to advanced cancer patients with inadequately controlled pain.
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The trial, titled Reborn1, is an open-label randomized study evaluating the effectiveness of inhaled QIXLEEF compared to morphine sulfate immediate release (MSIR) to treat cancer patients, who experience breakthrough pain – a sharp, intense pain episode.
Reborn1’s endpoint is the time-weighted sum of pain intensity differences (SPID) from pre-dose to 30 minutes after being treated with QIXLEEF or MSIR. Patients will evaluate their pain levels for each episode. In addition, secondary endpoints include difference in pain intensity and onset of pain relief at 5, 10, 15, 30 and 60 minutes, which will give insight to the timing of the onset of symptom relief for both treatments.
The study design includes a screening and titration period of up to two weeks, followed by an open-label crossover comparison study, where each patient will receive the investigational drug and active comparator for a seven-week treatment period, during which the groups will switch treatments in the third week.
Commenting on the FDA approval, Tetra CEO Guy Chamberland told shareholders: “This is really good news for all of us and in particular for the cancer patients that suffer from breakthrough pain. We aim to initiate this proof-of-concept trial designed to demonstrate that QIXLEEF can provide pain relief faster than an immediate-release oral morphine.”
QIXLEEF will round up its Phase II trial in 2021 and its Phase III trial in early 2022. Tetra plans to submit a New Drug Application by 2022 and launch the drug by late 2023.
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