Please login to the form below

Not currently logged in
Email:
Password:

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

Share

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Aurora Healthcare Communications

We're a leading healthcare strategic communications agency helping pharmaceutical companies adapt fast to improve the lives of patients and healthcare...

Latest intelligence

New from the PhRMA: Diversity in clinical trials principles summarised
In November 2020, PhRMA announced the first-ever, industry-wide principles on clinical trial diversity. The principles were approved by the PhRMA Boards of Directors and will take effect in April 2021....
New from the FDA: Diversity in clinical trials guidance summarised
In November 2020, the FDA released guidance to enable greater diversity in clinical trials through changes to eligibility criteria, enrolment practices, and trial designs....
5 steps to effective clinical trial branding
When recruiting patients for your clinical trial, you want the materials and information around it to be seen as reputable and professional. To make it clear what the clinical trial...

Infographics