CIP-TRAMADOL ER, an extended-release capsule formulation of the pain medication tramadol, failed to meet Phase III clinical trial endpoints.
According to Cipher Pharamaceuticals (CND), it's manufacturer, although treatment groups in the study demonstrated a reduction in pain from baseline, the drug failed to achieve a statistically significant improvement relative to placebo, which gave unexpectedly high effects.
Larry Andrews, Cipher President and Chief Executive Officer, still expresses hope, however.
"The 02.05 trial is the latest in a series of six Phase III trials completed by Cipher for CIP-TRAMADOL ER. The high placebo effect observed is disappointing; however, this is not an uncommon occurrence in placebo controlled pain trials.
We intend to complete our analysis of the 02.05 study and assess the potential contribution that the higher than anticipated placebo effect may have had on the outcome. This analysis will form part of the final report on the study".
The investors are not as confident, however, and Cipher's stocks took a plunge 24 percent on Monday following the announcement.
More details about the trial from Cipher's press release.
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