German pharmaceutical company, Grünenthal, showed off some promising data recently on its novel drug, cebranopadol, stating it reached statistical significance in treating cancer-relate pain without the dangers of respiratory depression seen with morphine sulfate.
The company says the drug is an analgesic that acts as a nociceptin/orphanin FQ peptide (NOP) receptor and opioid receptor agonist. They state it delivers both a comparable pain management to morphine sulfate PR (prolonged release), and an “improved safety profile, particularly as it relates to respiratory depression.”
“We are very proud to have discovered and developed this effective, well tolerated drug. Moreover, cebranopadol is clearly differentiated from other strong analgesics by its unique mechanism of action, improved safety profile with potentially limited effects on respiration and low abuse potential,” said Klaus-Dieter Langner, Chief Scientific Officer of Grünenthal.
“Cebranopadol addresses a high unmet medical need in several chronic pain types, and these new data show its potential in patients with cancer pain as well,” he added.
The data were presented at the International Association for the Study of Pain (IASP) 2016 meeting in Japan, and came from a Phase 3 randomized, double-blind, double-dummy, active-controlled multiple dose study with patients randomized to either once-daily cebranopadol or twice-daily morphine sulfate PR.
Results reached statistical significance for non-inferiority and also 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).
According to the company, the clinical trial was one of the largest conducted in cancer pain, but enrollment was “stopped for strategic reasons.” The company did not provide additional information on why.
Cebranopadol has previously demonstrated strong efficacy in moderate-to-severe chronic neuropathic pain and musculoskeletal pain. In total, the drug has been studied in approximately 2,000 patients worldwide having completed several Phase II trials in diabetic peripheral neuropathy (DPN), osteoarthritis (OA) and chronic low back pain (cLBP) and is ready for further Phase III development.