In the 41 patient trial, patients were given either a single dose of the drug known only as 4975 or placebo, which was instilled (dripped by syringe) into the wound over approximately one minute prior to wound closure.
All patients in both the treatment and placebo arms received paracetamol and non-steroidal anti-inflammatory drugs for one week following surgery, a mandated standard of care in Denmark where the trial was conducted.
While 4975 was well tolerated at all time points during the study, there was no significant difference in pain score in the drug versus control arm.
“We believe that concomitant administration of pain killing drugs may have confounded the results of this trial since the results are inconsistent with data obtained from multiple previous phase II trials of 4975 that demonstrated significant, sustained pain reduction versus placebo in other indications,” stated Dr Daniel Gennevois, vice president of medical affairs at Corgentech.