FDA Not Ready to Decide on Adolor Drug

Adolor(ADLR Quote) revealed Thursday that the Food and Drug Administration needs more time to review submissions for a release on the clinical hold of its lead prospect, Entereg, for postoperative ileus (POI).

The company and its development partner, GlaxoSmithKline(GSK Quote), said the agency didn't indicate how much time would be required, and a clinical hold for all investigational new-drug applications (INDs) will remain in effect for Entereg, which treats a side effect sometimes seen among surgical patients who receive powerful painkillers such as morphine.

The Entereg Saga

Last November, the FDA requested more information -- a total of 12 months of safety data, including information on cardiovascular risks -- as part of an approvable letter for the new-drug application (NDA) for Entereg. The agency said it wouldn't a final decision until Adolor and GlaxoSmithKline completed an ongoing clinical trial and submitted a risk-management plan to the regulatory agency.

Then in April, shares plummeted some 55% when the company halted a clinical trial, saying preliminary data from a late-stage study implied there was a numerical imbalance of side effects such as benign and cancerous lesions, fractures and cardiovascular events in Entereg patients vs. the placebo.

In June, FDA put the INDs of Entereg on clinical hold, requesting the results of a study of the drug in cancer pain patients with opiod-induced bowel dysfunction and more data on two-year carcinogenicity studies in rats and mice.