Cebranopadol Meets Endpoint in Trial With Prolonged-Release Morphine

Cebranopadol, a first-in-class analgesic, met its primary endpoint in a Phase III trial of patients with cancer-related pain. Cebranopadol acts as a nociceptin/orphanin FQ peptide receptor and opioid receptor agonist.

Patients were randomized to once-daily cebranopadol or twice-daily prolonged release morphine sulfate, and demonstrated statistical significance for non-inferiority in the average amount of daily rescue medication intake over the last two weeks of the trial’s maintenance phase.

Cebranopadol was well tolerated, with side effects comparable to morphine sulfate PR, according to Grünenthal, the drug’s sponsor. Cebranopadol has also been studied in chronic pain due to osteoarthritis, chronic low back pain and diabetic peripheral neuropathy, and has shown an improved safety profile, particularly as it pertains to respiratory depression, compared to standard opioid painkillers, the company said.