Adolor hit by FDA's approvable letter for Entereg

Adolor shares took a tumble early this morning after the company announced that the FDA had issued an approvable letter for the postoperative bowel therapy Entereg, a drug it is developing with GlaxoSmithKline. Glaxo shares shed some value in early trading as analysts seemed chiefly concerned that this new delay for Entereg signaled yet another holdup for the big European drug developer. The FDA asked for 12-month safety data including an analysis of cardiovascular risks as well as a risk management plan. An ongoing study of Entereg should wrap in the first quarter of 2007. Data from an Entereg study demonstrated that patients taking the disease who had heart disease were at a high risk of cardiovascular events, an outcome researchers for the companies said was to be expected. Entereg is being developed to treat the nausea, vomiting and other side effects commonly associated with surgery. The ongoing late-stage trial is to determine Entereg's ability to relieve constipation among patients taking opiates for chronic pain.

- here's the AP report on Entereg