FDA retracts hold on alvimopan

July 21, 2008

However, partner in drug development deal may be backing out.

The U.S. Food & Drug Administration revoked a clinical hold on Entereg, according to Adolor Corp. The drug is under development for treatment of bowel dysfunction in individuals on opioid therapy. Despite this news, partner GlaxoSmithKline is considering backing out of the development arrangement.

Alvimopan (Entereg) received FDA approval in May for the treatment of post-operative ileus. The following month, FDA issued a hold on further studies of the drug pending submission and requested data analysis.

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