Researchers behind the potential new opioid, cebranopadol, presented efficacy and safety results at PAINWeek 2016 in Las Vegas, Nevada.
The German pharmaceutical company, Grünenthal, is currently developing a novel first-in-class opioid to treat chronic pain conditions. The drug, cebranopadol, is believed to work through nonciceptin/orphanin FQ peptide (NOP) receptor and opioid receptor agonism. Researchers behind the potential new opioid presented efficacy and safety results at PAINWeek 2016 in Las Vegas, Nevada.
The researchers recruited 641 patients for a randomized trial and they either received placebo, tapentadol ER 200 mg BID, or cebranopadol 200µg, 400 µg, or 600 µg. There was a titration phase for over two weeks which was followed by 12 weeks of maintenance.
The 11-point numerical rating scale (NRS) showed a mean baseline pain score of 7.1.
“All cebranopadol doses significantly reduced pain according to MMRM analysis and multiple comparison procedure,” the authors detailed, “(change from baseline to week 12 of maintenance on average 24-hour NRS; p value versus placebo): -2.95, -2.95, -3.18 for cebranopadol 200µg, 400 µg, or 600 µg, - 3.05 and -2.16 for tapentadol and placebo, respectively.”
The analgesic effects occurred within the first two weeks of treatment. A minimum 50% pain reduction occurred in the following: 36.5% taking cebranopadol 200µg, 40.6% taking cebranopadol 400µg, 38.9% taking cebranopadol 600µg, 43.8% taking tapentadol, and 27.5% taking placebo.
The most common treatment-emerged adverse events in all of the groups were nausea, constipation, vomiting, dizziness, and somnolence. The effects were more common in the cebranopadol groups (85.7%) than in the tapentadol (79.4%) and placebo (65.1%) groups. However, electrocardiogram (ECG) showed no systematic effects with the use of cebranopadol.
The team determined that cebranopadol is safe, effective, and well-tolerated in those with mixed types of chronic low back pain.
In November 2015, officials from Depomed, Inc., an American specialty pharmaceutical company, acquired the US and Canadian rights to cebranopadol and its compound, Grünenthal GmbH. It is anticipated that the drug will enter phase III trials for chronic low back pain and other pain disorders.
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