Tris Pharma Reveals New Data on Cebranopadol's Safety and Efficacy for Pain Treatment

Tris Pharma, Inc., a biopharmaceutical company based in Monmouth Junction, New Jersey, has released new clinical data regarding cebranopadol, a dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor agonist. The findings indicate that cebranopadol results in significantly lower respiratory depression compared to oxycodone. 

According to James Hackworth, Ph.D., president of Tris Pharma's brand division, the study suggests that cebranopadol can manage pain effectively while reducing the risk of respiratory complications associated with MOP receptors. As a pioneering dual-NMR agonist aimed at treating moderate-to-severe pain, cebranopadol promises reduced side effects and lower abuse potential compared to traditional opioids. These new findings on respiratory safety add to the growing evidence supporting cebranopadol as a safer opioid alternative, with plans for Phase 3 studies underway.

Respiratory depression is a severe and potentially fatal side effect of opioid treatment, primarily mediated by MOP receptor activation. The clinical study presented at the IASP compared cebranopadol and oxycodone at doses exceeding therapeutic levels to assess their impact on respiratory function, analgesic effectiveness, and the potential for a ceiling effect for respiratory depression with cebranopadol. The double-blind, placebo-controlled study included 30 healthy volunteers over a four-week period, who were randomly assigned to receive cebranopadol, oxycodone, or a placebo.

Key results from the study, presented in a poster titled "Cebranopadol effects on ventilatory drive, central nervous system, and pain," include:
- Cebranopadol caused 25% less respiratory depression than oxycodone at equianalgesic doses.
- Cebranopadol allowed for a slower onset of respiratory effects, enabling gradual CO2 accumulation and reducing the severity of respiratory depression.
- The drug provided prolonged pain relief with a gradual onset and offset.
- Over a 24-hour period, cebranopadol was associated with fewer respiratory adverse events, such as apnea and decreases in respiratory function and oxygen saturation, compared to oxycodone.

Albert Dahan, M.D., professor of anesthesiology at Leiden University Medical Center, noted that the delayed respiratory effects of cebranopadol enhance its safety profile, offering a potential new avenue for effective pain management that minimizes common opioid-related side effects. These findings, combined with previous research, suggest that cebranopadol could offer a safer therapeutic option for both acute and chronic pain by potentially creating a ceiling effect for respiratory depression.

Cebranopadol (TRN-228) is an investigational dual-NMR agonist designed for moderate-to-severe pain and opioid use disorder (OUD). Its unique mechanism leverages the properties of the NOP receptor to reduce misuse risk while maintaining effective pain relief and blocking drug-seeking behaviors associated with abuse. The FDA has granted cebranopadol Fast Track Designation for chronic low back pain. If approved, cebranopadol could become the first pain relief therapy with efficacy comparable to opioids but with significantly less misuse potential and reduced risk of dependence, addiction, or overdose.

Tris Pharma is dedicated to innovation in biopharmaceuticals, focusing on treatments for ADHD, pain, and neurological disorders including addiction and central nervous system diseases. The company boasts a strong portfolio of ADHD products and a promising pipeline of near-term drug candidates.

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