FDA committee to discuss fate of Entereg at Jan 23 meeting

The US Food and Drug Administration will meet later this month to review the safety and effectiveness of Entereg/Entrareg (alvimopan), a drug candidate for post-operative ileus and opioid-induced constipation originated by USA-based Adolor and licensed to UK drug major GlaxoSmithKline. On January 23, the Gastrointestinal Drugs Advisory Committee of the FDA will decide on the fate of the drug after over a year of delays that have left many analysts doubting its chances of approval. Last year, the companies postponed the agent's development after it showed a high rate of adverse events. The news sent shares in Exton, Pennsylvania-based Adolor plummetting 57% (Marketletter April 16, 2007). Entereg is the firm's lead candidate and other agents in its pipeline are years away from the market.