Once again, Adolor Corp and GlaxoSmithKline have been kept waiting by US regulators in their bid to get Entereg on the market.

The US Food and Drug Administration told Adolor that it will not be issuing an action letter on the New Drug Application for Entereg (alvimopan) for postoperative ileus which was due last Saturday (May 10). The agency did not provide a specific date, but informed the company that it expects to issue the action letter shortly.

It is the second time the FDA had delayed a decision on Entereg as it was originally expected to issue an action letter on February 10. An agency advisory panel recommended use of the drug in January but warned that GSK and Adolor’s risk management programme would need strengthening because of the long-term risk of heart attack.

The companies first filed for FDA approval of Entereg in 2004 to treat postoperative ileus, a transient impairment of bowel motility that often follows abdominal surgery. The agency has now issued two approvable letters, the second being in November 2006, and subsequently requested additional data to the firms’ complete response to this letter after a study last April showed an increased cardiovascular and fracture risk in Entereg patients.

Generic Requip approved for RLS
Meantime, the FDA has approved the first generic versions of GSK’s Requip (ropinirole) for the treatment of moderate to severe restless legs syndrome.

Roxane Laboratories, Teva, Par Pharmaceuticals and Mylan have been given the nod to sell their versions of Requip, which had US sales of $518 million in 2007, though the FDA noted that the drug is still patent protected as a treatment for Parkinson's disease. However, generics firms may seek approval for this indication once the patent expires later this month.