Shares of Adolor took off this morning, climbing 18 percent after the company issued a joint release with GlaxoSmithKline that the FDA had accepted their response to the agency's approvable letter for the constipation drug Entereg (alvimopan). The FDA had placed the trials on clinical hold and asked for more data. The companies are waiting on a request to lift the clinical hold so they can resume trials.
"The FDA informed Adolor that the response is considered a complete class 2 response with a Prescription Drug User Fee Act (PDUFA) goal date of February 10, 2008," according to the release.
- see the release
- read the report from Hemscott
Related Articles:
FDA wants more safety data on Entereg. Report
Adolor shelves Entereg studies; shares plunge. Report
FDA needs more data on Adolor drug. Report
Adolor hit by FDA's approvable letter for Entereg. Report
Adolor shares in meltdown on trial data. Report