Tris Pharma's Cebranopadol Completes Phase 3 Program, Paving Way for FDA Submission

Tris Pharma has announced the successful completion of its phase 3 clinical trial program for cebranopadol, a novel dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor agonist, positioning the company to submit a comprehensive data package to the FDA for potential approval as a treatment for moderate-to-severe acute pain.

Third Clinical Win Demonstrates Significant Pain Reduction

The latest phase 3 trial, focusing on patients who underwent toe surgery, showed that cebranopadol achieved its primary endpoint with a statistically significant reduction in pain intensity. Patients receiving a once-daily 400-µg dose of cebranopadol experienced a mean 56.1-point reduction in pain measurement compared to placebo (p<0.001) over 48 hours.

Notably, 57.5% of patients in the cebranopadol group did not require additional "rescue medication" over seven days, compared to only 28.4% in the placebo group. While a separate arm of the study using oxycodone demonstrated more pain relief than cebranopadol, Tris Pharma noted this was "expected" and emphasized that cebranopadol still showed a favorable efficacy profile.

Safety Profile and Potential as Opioid Alternative

Cebranopadol exhibited a favorable safety profile in the trial, with nausea being the most common adverse event and no serious adverse events reported. This latest data adds to the drug's growing clinical evidence as a potential alternative to traditional opioids in pain management.

Ketan Mehta, CEO of Tris Pharma, stated, "If approved, cebranopadol has the potential to redefine the standard of care for acute pain management, offering a first-in-kind treatment option for patients in need."

The company believes cebranopadol's unique mechanism of action, which stimulates both MOP and NOP receptors, may avoid the addictive effects associated with traditional opioids while still providing effective pain relief.

Comprehensive Data Package and FDA Submission

With the completion of its phase 3 program, Tris Pharma now possesses a comprehensive data package for cebranopadol, including results from two previous clinical trials. In January, the company reported a statistically significant reduction in pain intensity for patients undergoing cosmetic abdominal surgery. Additionally, a phase 1 trial demonstrated that crushed, nasally insufflated cebranopadol was less likely to be abused compared to oxycodone.

As the opioid crisis continues to be a significant public health concern, Tris Pharma's cebranopadol represents a potential new approach to pain management. The company plans to submit its data package to the FDA this year, marking a significant step forward in the development of novel pain treatments.