Additional Relevant Details Poster 160480 "Cebranopadol: A Novel First-In-Class Analgesic in Development for Chronic Pain Conditions – Results from a Human Abuse Potential Study in Non-Dependent Recreational Opioid Users" reported data from a Phase I study of 48 healthy, non-dependent recreational opioid users. The study assessed the abuse potential of three different orally administered doses of cebranopadol (200, 400 and 800 μg), placebo and two doses of hydromorphone (8 and 16 mg) as a comparator to rate "drug liking", a traditional endpoint for this type of study. Data show that, as expected, hydromorphone generated a dose-dependent increase in likeability, whereas placebo showed little likeability with cebranopadol at therapeutic doses exhibiting similar likeability scores to placebo.
Link: http://simul-europe.com/2016/wip/HtmlPage1.html?prodId=(marielle.eerdekens@grunenthal.com)Cebranopadol%20Poster%20human%20abuse%20WIP%20160480_X4.pdf.jpgPoster 160319 "Cebranopadol: A Novel, First-In-Class Analgesic: Efficacy, Safety, Tolerability in Patients with Mixed Chronic Low Back Pain" reviewed data from the Phase IIb trial of 635 patients with moderate-to-severe cLBP.  This randomized, double-blind, placebo- and active-controlled, five-arm, monotherapy trial assessed the analgesic efficacy, safety, and tolerability of once daily oral dose of cebranopadol at three fixed doses (i.e., 200, 400, and 600 μg) compared to placebo and tapentadol prolonged release, as the active comparator. Data show all three doses of cebranopadol resulted in robust, clinically and statistically significant, and dose-dependent improvements in pain, with p values of 0.0095, 0.0122, and 0.0021 for 200, 400, and 600 μg, respectively, compared to placebo.  
Link: http://simul-europe.com/2016/wip/HtmlPage1.html?prodId=(marielle.eerdekens@grunenthal.com)Cebranopadol%20Poster%20LBP%20WIP160319.pdf.jpgPoster 160303 "Cebranopadol: A Novel, First-In-Class Analgesic in Development for Chronic Pain Conditions – Effects on Respiration in Healthy Human Volunteers" reported data from a Phase I trial of 12 healthy male subjects. This study assessed the effects of a single oral dose of cebranopadol (600 μg) compared to an intravenous dose of fentanyl (3.5 μg/kg). Data show that cebranopadol demonstrated a less pronounced and significantly delayed effect upon respiratory parameters (respiratory rate, ventilation and oxygen saturation) as compared to fentanyl, and that these changes appear to demonstrate a "ceiling effect".
Link: http://simul-europe.com/2016/wip/HtmlPage1.html?prodId=(marielle.eerdekens@grunenthal.com)Cebranopadol%20Poster%20respiration%20WIP160303.pdf.jpgPoster 160478 "Cebranopadol: A Novel, First-In-Class Analgesic: Efficacy, Safety, Tolerability in Patients with Pain Due to Diabetic Peripheral Neuropathy (DPN)" reviewed data from an exploratory Phase IIb trial of 314 patients with moderate to severe chronic pain due to DPN. This 5-arm, placebo- and active-controlled, parallel design trial compared the analgesic efficacy, safety and tolerability of once daily orally administered cebranopadol at 3 fixed doses (100, 300 and 600 μg) compared to placebo and pregabalin at 600 mg (300 mg twice-a-day) as the active comparator. Data show that at the highest dose of 600 μg, patients achieved clinically and statistically significant improvements in pain (p=0.0153). The other two cebranopadol arms demonstrated a trend towards statistical significance, but did not achieve it in this exploratory trial.  Results also showed an absolute reduction in pain, which was -2.56, -2.28, and -2.24 on an 11-point scale for the 600, 300 and 100 μg doses, respectively as compared to -1.55 for placebo with evidence of a dose-response relationship.  
Link http://simul-europe.com/2016/wip/HtmlPage1.html?prodId=(marielle.eerdekens@grunenthal.com)Cebranopadol%20Poster%20DPN%20WIP%20160478.pdf.jpg