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Omeros phase III knee surgery drug fails

A Omeros Corporation drug developed to increase mobility and reduce pain in patients who have undergone arthroscopic knee surgery has failed to meet the primary endpoints of a phase III programme

Omeros Corporation's lead product candidate, a drug intended to increase mobility and reduce pain in patients who have undergone arthroscopic knee surgery, has failed to meet the primary endpoints of a phase III programme because of confounding factors that made it impossible to draw conclusions from the research, according to the company.

The drug was being evaluated in patients undergoing arthroscopic anterior cruciate ligament (ACL) reconstruction surgery, an indication for which no other pharmaceuticals are approved in the US. Currently known as OMS103HP, it is a proprietary combination of ketoprofen, amytriptyline and oxymetazoline that is injected into standard arthroscopic irrigation solutions and perfused through the knee during surgery.

"Our analysis of the data does not demonstrate a lack of drug effect nor does it appear to undermine the viability of our phase III-ready OMS103HP programme for meniscectomy surgery," said Omeros Chairman and CEO Gregory A Demopulos. "As we learn more from our data analysis, we will provide additional information on our plans for OMS103HP."

An earlier phase I/II study of OMS103HP conducted at Stanford University in patients undergoing arthroscopic knee surgery for ACL reconstruction showed statistically significant improvement in postoperative knee range of motion and function, better pain management and earlier return to work, according to Omeros.

4th April 2011

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