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FDA Not Ready to Decide on Adolor Drug

The agency needs more time to review submissions for a release on the clinical hold on Entereg.



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,


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, 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.

Adolor and Glaxo now have submitted complete responses to the FDA requesting a release of the clinical holds for all Entereg INDs. Also, the FDA accepted as complete Adolor's response to the NDA approvable letter from last November, setting a Prescription Drug User Fee Act (PDUFA) goal date for the review to be complete of Feb. 10, 2008.

The agency said Thursday it needs an undefined amount of additional time to make up its mind about releasing the clinical holds for the INDs, a requirement before re-initiating any clinical development activities.

Even so, the companies said they're still preparing for a February NDA review.

Adolor shares gave up 24 cents, or 6%, to $3.74. Glaxo was up 58 cents, or 1.1%, to $54.30.