FDA OKs Adolor's Entereg in first approval

Exton, PA-based Adolor hit a major milestone with the FDA's approval of Entereg for postoperative ileus, a common condition following surgery that can extend a patient's hospital stay. This is the first approval for Adolor, which partnered with GlaxoSmithKline to get the drug through the approval process. Adolor gained $50 million up front from its pact with GSK and signed on to up to $220 million more in milestones.

The FDA's approval marks "the culmination of a substantial collaborative effort among Adolor, GlaxoSmithKline, and our clinical investigators," Adolor CEO Michael R. Dougherty said in a statement. "Entereg is the first and only product that has demonstrated the ability to address this serious condition, which has negative consequences for patients, and imposes considerable expense on the health-care system."

It wasn't easy. Researchers had to deal with two approvable letters from the FDA, in 2005 and 2006, and a three-month delay at the beginning of the year.

- check out this release
- read the report from the Triangle Business Journal

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