Pain relief drug shows low potential for abuse in phase 1 trial
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Cebranopadol, a pain relief drug, showed low potential for abuse among nondependent recreational opioid users compared with tramadol or oxycodone, researchers from Tris Pharma Inc. stated in a press release.
“Cebranopadol is a novel pain medication and works in a fundamentally different way by being an agonist to this [nociceptin/orphanin FQ peptide] receptor, which is new, as well as more traditional receptors,” James Hackworth, PhD, BS, president of brand division at Tris Pharma, told Healio.
According to the release, multiple clinical studies have demonstrated that cebranopadol is efficacious for different types of pain. In addition, data has shown that cebranopadol has significantly lower risks for abuse, withdrawal, dependence and overdose.
The FDA has granted cebranopadol fast track designation.
“There are tens of millions of people suffering from severe pain every year, and their only option is typically opioids, which are highly addictive and can be very dangerous and easy to overdose on,” Hackworth said. “And so, there is a big need for drugs that can treat pain at that level that are also safer. And that is what we believe cebranopadol is.”
According to Hackworth, the trial was designed specifically to test cebranopadol’s abuse potential. It was a trial that was not required, but one of the researchers felt it was important to conduct, he said.
“We wanted to test [cebranopadol’s] abuse potential against oxycodone, which is of course a drug of very high abuse potential, as well as tramadol, a drug in the same class, which is of lesser abuse potential,” he said.
According to Hackworth, cebranopadol was not preferred at all by abusers, which gave researchers more confidence in the drug as they move forward into phase 3 trials.
“We now can say definitively that when the drug is taken for pain in its therapeutic range, it produces no euphoria, no liking,” Hackworth said. “And that is very important, because very often people become opioid abusers by getting a legitimate prescription for a pain medication.”
In addition, Hackworth noted that even at very high doses of cebranopadol, the drug was still not preferred by abusers, compared with tramadol and oxycodone.
“We believe that [cebranopadol] would be a drug that would not be likely to be diverted and it would be safe to prescribe and not to add to the public health crisis that we are in,” he said.