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Regulatory News: Article   Printable Version 


Regulatory News Article
Clinical Hold Lifted for Entereg®

The U.S. Food and Drug Administration (FDA) has lifted its clinical hold on Adolor Corporation’s constipation drug Entereg® (alvimopan). Entereg is being developed with GlaxoSmithKline PLC for the treatment of chronically constipated patients who are taking opioid drugs for pain.

The clinical hold was placed on Entereg due to the FDA’s concern that not enough was being done in terms of managing potentially risky side effects of the drug.

Enterg is already approved for the treatment of postoperative ileus following abdominal surgery.



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These materials may discuss uses and dosages for therapeutic products that have not been approved by the United States Food and Drug Administration. All readers should verify all information and data before administering any drug, therapy or treatment discussed herein. Neither the editors nor the publisher accepts any responsibility for the accuracy of the information or consequences from the use or misuse of the information contained herein.
© 1998-2007 OncoEd, Inc  All Rights Reserved.

These materials may discuss uses and dosages for therapeutic products that have not been approved by the United States Food and Drug Administration. All readers should verify all information and data before administering any drug, therapy or treatment discussed herein. Neither the editors nor the publisher accepts any responsibility for the accuracy of the information or consequences from the use or misuse of the information contained herein.




   




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