FDA SATISFIED WITH ENTEREG EFFICACY RESULTS, BUT WANTS MORE SAFETY DATA

Adolor and GlaxoSmithKline's (GSK) Entereg faces yet another obstacle, as the FDA has issued an approvable letter requiring more data for the gastrointestinal drug.

The agency requested further safety data from an ongoing trial known as "study 104," as well as a risk management plan, according to a Nov. 6 announcement from Adolor. GSK and Adolor are seeking approval for Entereg (alvimopan) to treat postoperative ileus, a common complication from gastrointestinal surgery.

Data from a six-month analysis showed a small increase in serious cardiovascular adverse events in patients taking alvimopan. The increase was not statistically significant, Adolor said. The company also noted that the reported events happened in patients at high risk for cardiovascular disease and were consistent with expectations for that population.

Final data from the study should be available in the second quarter of 2007, according to Adolor. CEO David Madden said Adolor would give the FDA more study data and the risk management plan as quickly as possible.