Cebranopadol Shows Lower Abuse Potential Compared to Existing Pain Therapies
A supratherapeutic dose of 1000 ug cebranopadol was significantly less likeable compared to 40 mg oxycodone when crushed and taken intranasally.
Positive results from an intranasal human abuse potential study evaluating the intranasal pharmacokinetics and abuse potential of cebranopadol compared to oxycodone in adult nondependent recreational opioid users have been released, Tris Pharma announced in a release.1 The company said it plans to present full results from the study at an upcoming conference.
Cebranopadol Shows Lower Abuse Potential Compared to Existing Pain Therapies / JAY - stock.adobe.com
Results from the study showed a supratherapeutic dose of 1000 ug cebranopadol—which is 2.5 times higher than the therapeutic dose for the treatment of pain—was significantly less likeable compared to 40 mg oxycodone when crushed and taken intranasally. Other data from the study showed a large disparity in positive subjective effects for cebranopadol compared to oxycodone, with more patients indicating they would take and liked oxycodone more.
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“Some people misuse opioids intranasally to generate a faster and more intense high compared to the oral route, which can be a precursor to using other opioids such as heroin or fentanyl, or the injection route,” Mark Greenwald, PhD, professor and associate chair for research at Wayne State University Department of Psychiatry and Behavioral Neurosciences, said in a release.1 “These results suggest that opioid misusers would be unlikely to do that with cebranopadol.”
Cebranopadol is a first-in-class investigational therapy for the treatment of moderate-to-severe pain. It’s a dual-NMR agonist, as it targets the nociceptin/orphanin FQ receptor and the µ-opioid receptor. Cebranopadol has the potential to treat many types of pain and was granted fast track designation by the FDA for chronic low back pain.
In a previous human abuse potential study, cebranopadol demonstrated significantly lower oral abuse potential compared to oxycodone and tramadol. When both abuse potential studies were compared, it showed the likability of cebranopadol decreased and peak effects occurred hours after administration, compared to 40 mg oxycodone which saw an increase in drug liking and a rapid onset of effect.
“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,” Ketan Mehta, founder and CEO of Tris Pharma, said in a release.1 “We are excited by these results, which coupled with our recent positive topline data from the pivotal Phase 3 ALLEVIATE-1 study, help to solidify cebranopadol’s potential to transform pain management.”
ALLEVIATE-1 is phase 3 trial evaluating the efficacy and safety of cebranopadol for the treatment of moderate to severe acute pain in adult patients following full abdominoplasty. In topline data that was recently released by Tris, treatment with 400 ug cebranopadol once per day for 2 days resulted in a statistically significant reduction in pain intensity versus placebo. The therapy was also seen to be generally well tolerated with a favorable safety profile.
Tris said it plans to share results from the pivotal Phase 3 ALLEVIATE-2 clinical study evaluating cebranopadol for the treatment of pain in patients following bunionectomy in the first quarter of 2025. The company also said it anticipates submitting a new drug application to the FDA for cebranopadol later this year. Additionally, Tris plans to conduct cebranopadol studies in multiple chronic pain indications beginning in the second half of 2025.
READ MORE: Pain Management Resource Center
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