>>All patients in both the treatment and placebo arms received paracetamol (acetaminophen) and non-steroidal anti-inflammatory drugs (NSAIDs: ibuprofen) 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 2 trials of 4975 that demonstrated significant, sustained pain reduction versus placebo in other indications," stated Daniel J. Gennevois, M.D., vice president of medical affairs at Corgentech. "Several aspects of this study's design were different from other studies we have conducted. Mainly, paracetamol and NSAIDs were systematically administered to both the treatment and placebo arms for a week. Therefore, the pain score for the placebo arm during the first week after surgery was quite low, making it difficult to show a drug effect of 4975 during the first week when the pain should be the most intense. The pain scores were sufficiently low on the visual analog scale (VAS) of one to 100 (4975 group = 14.4, placebo group = 17.5) that most clinicians would deem there to be clinically insignificant pain or no pain at all."<<
I don't follow CGTK closely since their first failure, so I don't know, but definitely wonder, if this mandatory administration of other pain drugs in Denmark was disclosed by the company. Disclosed or not, they must have known, so that makes this another in the annals of stupid trial design (not quite as stupid as ENCY dosing a rat that was abnormal, causing the FDA to put a hold on the trials of their back-up ER antagonist, but close). Or it means their drug really isn't any better than aspirin. So no wonder the stock is down over 7% after hours; I am surprised it is not more.
Cheers, Tuck |
