FDA Lifts Clinical Hold on Entereg for OBD

July 8, 2008

The FDA has lifted its clinical hold on an IND for Adolor and GlaxoSmithKline’s (GSK) Entereg to treat chronic opioid bowel dysfunction (OBD).

The firms suspended development of the compound last year following safety concerns that surfaced in clinical trials for treatment of OBD, including serious cardiovascular adverse events, skin cancers, polyps and bone fractures.

Adolor said GSK is evaluating its options for the OBD program. The agreement between the companies allows GSK to terminate its involvement with the OBD product while retaining rights to Entereg for postoperative ileus after bowel resection surgeries. The drug received approval for that indication earlier this year.