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

Related Articles:
FDA delays Entereg decision
GSK, Adolor face another Entereg delay
Entereg wins key FDA advisory committee vote
Investors cheer FDA's acceptance of Entereg response
FDA wants more safety data on Entereg

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