Tris Pharma’s opioid alternative has scored a third win in a trio of clinical trials, providing the biotech with the data needed to take the pain relief drug to the FDA this year.
The latest readout saw cebranopadol, a dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor agonist, tested in a phase 3 trial of patients who have undergone toe surgery.
The study achieved its primary endpoint of showing a statistically significant reduction in pain intensity measured each hour over 48 hours compared to placebo. Specifically, a once-daily 400-µg dose of cebranopadol resulted in a mean 56.1-point reduction in this pain measurement compared to placebo, giving a p-value of less than 0.001.
A total of 57.5% of patients receiving cebranopadol didn’t require an additional “rescue medication” of a common analgesic, such as ibuprofen, over seven days compared to 28.4% of those on placebo, the biotech noted.
A separate arm of the study involved patients receiving the common opioid oxycodone four times a day. The mean pain relief experienced by these patients was also less than the cebranopadol cohort, the company said.
