FDA's May 20 approval of Entereg for post-operative ileus ended the drug's long regulatory haul.

Adolor and development partner GlaxoSmithKline won marketing clearance for Entereg (alvimopan) to end constipation in hospitalized adult patients who have undergone partial large or small bowel resection surgery.

A 12-mg capsule of Entereg is given just before surgery, and another twice daily for up to seven days after.

FDA had let slide the May 10 action date, wanting more time to check out the management program for Entereg. The peripherally-acting mu-opioid receptor antagonist seemed to increase heart-attack risk in one long-term study in patients given opioids (¹ Also see "FDA Needs More Time To Review GSK/Adolor’s Entereg" - Pink Sheet, 9 May, 2008.).

In January, an FDA panel found Entereg "approvable," but the risk-management plan haphazard (² Also see "GSK/Adolor's Entereg Eligible For Approval, But Lacks Proper Risk Management Plan, Advisory Panel Says" - Pink Sheet, 23 January, 2008.).

The risk evaluation and mitigation strategy that goes with Entereg's approval limits its use to in-patients and requires that hospitals be specially certified. Doctors will get educational materials, and the REMS will be closely watched.

Exton, Pa.-based Adolor slated a conference call for May 21 to discuss the approval.

Wyeth and Progenics' Relistor (methylnaltrexone) - which works similarly to Entereg - gained FDA's blessing in late April for opioid induced constipation, and approval in Europe is expected mid-year (³ Also see "Wyeth/Progenics’ Relistor: FDA Says Yes, EU Likes It, Too" - Pink Sheet, 24 April, 2008.).

Relistor is used in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Relistor is also being studied in POI, with Phase II trials ongoing.

- Randall Osborne (r.osborne@elsevier.com)

Adolor/GSK’s Entereg Approved By FDA

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