Having shown last week that its opioid alternative can reduce post-surgery pain, Tris Pharma is back with another slice of clinical data to show that the drug is less likely to be abused.
The phase 1 study gave adult non-dependent recreational opioid users a single crushed dose of either Tris’ cebranopadol, the common opioid oxycodone or placebo to snort. The dose of cebranopadol was 1000 µg, which is 2.5 times higher than the dose that Tris is planning to use as a pain treatment, the biotech noted.
Abuse potential was determined based on a patient-provided score of the drugs' likeability. The trial hit the study’s primary endpoint of showing a lower likeability score, 67.3, for cebranopadol than for oxycodone's 92.1.
Tris also compared the results to a previous trial of oral doses of the drugs. This showed that while oxycodone is more likeable when snorted than when swallowed—where it had a score of 83.9—the score for oral cebranopadol—at 69.2—was very similar to the nasal version.
Cebranopadol is a dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor agonist. While cebranopadol stimulates the MOP receptor in the same way that opioids do, its ability to also stimulate the NOP receptor avoids the other effects that have contributed to opioids’ addictiveness, according to Tris.
“Together with prior human abuse potential studies, these results provide strong support for the significantly lower abusability of cebranopadol compared to existing therapies that treat moderate-to-severe pain, including opioids,” Tris CEO Ketan Mehta said in the Jan. 28 release.
As well as last week’s phase 3 readout for patients who have undergone cosmetic surgery on their abdomen, this year is also set to see a phase 3 readout in patients who have undergone toe surgery. The current plan for the rest of the year is to submit an approval application to the FDA as well as to launch further trials in “multiple chronic pain indications,” according to the privately owned biotech.
The National Institutes of Health’s National Institute on Drug Abuse awarded Tris a five-year grant back in 2023—worth up to $16.6 million—to study cebranopadol’s potential to treat opioid use disorders and substance use disorders.
Tris isn't the only company looking for a new way to treat pain; the FDA is planning to make an approval decision on Vertex Pharmaceuticals’ NaV1.8 pain signal inhibitor suzetrigine by the end of this month. But Tris chief business officer James Hackworth, Ph.D., told Fierce earlier this month that he sees Vertex’s offering as “more complementary” than competitive to cebranopadol.