Grünenthal's cebranopadol meets primary efficacy endpoint in Phase III trial in cancer pain

German family-owned drugmaker Grünenthal on Friday presented data for the first time of its compound cebranopadol in patients with cancer-related pain at the International Association for the Study of Pain (IASP) 2016 meeting in Japan.

The cebranopadol data is from a Phase III randomized, double-blind, double-dummy, active-controlled multiple dose study with patients randomized to either once-daily cebranopadol or twice-daily morphine sulfate PR (prolonged release). Results reached statistical significance for non-inferiority and even superiority for the primary endpoint (average amount of daily rescue medication intake over the last two weeks of the maintenance phase in the trial, p<0.05). Cebranopadol was well tolerated, with side effects comparable to morphine sulfate PR. Enrollment in this trial, which is one of the largest trials conducted in cancer pain to date, was stopped for strategic reasons.

Cebranopadol, a novel first-in-class analgesic, discovered and developed by Grünenthal, has previously demonstrated strong efficacy in moderate to severe, chronic neuropathic pain and musculoskeletal pain. Grünenthal is actively seeking for development and commercialization partners to make cebranopadol available for patients in Asia.