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Article: Other News To Note.
- Article from:
- BIOWORLD Today
- Article date:
- November 3, 2009
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o Adolor Corp., of Exton, Pa., and GlaxoSmithKline, of London, said the FDA has requested additional data be submitted as part of the complete response to the agency's Nov. 6, 2006, approvable letter for alvimopan in postoperative ileus. The additional data include the final results of Study 101684, an extension of the Phase IIb Study 008 of alvimopan in cancer pain patients with opioid-induced bowel dysfunction (OBD), further analysis of results from Study 014 and the final study reports from the two-year carcinogenicity studies in rats and mice, which were conducted to support the OBD indication. The FDA also requested safety data from Adolor's co-administered study of ...