Tramadol-ER fails in latest Phase III trial

Researchers at Canada's Cipher Pharmaceuticals are blaming an unexpectedly high placebo response for the failure of the pain drug Tramadol-ER in a new Phase III trial. Because of the placebo effect, says Cipher, the drug failed to achieve a statistically significant improvement among volunteers. But Cipher says it can still rely on a mountain of positive data from six completed pharmacokinetic studies and five Phase III studies to back up its NDA for the extended-release formulation. Investors weren't so sure, sending the company's shares down 25 percent.

"The clinical package we submitted to the FDA in June met the requirements for a complete NDA submission as evidenced by the fact it has now been accepted for review. We believe there is sufficient data in the package to support regulatory approval," said Larry Andrews, president and CEO of Cipher Pharmaceuticals.

- see the release on the trial results