WASHINGTON The Food and Drug Administration’s Gastrointestinal Drugs Advisory Committee will meet in January to discuss GlaxoSmithKline and Adolor’s opioid receptor antagonist Entereg. The drug is designed to block the adverse side effects of opioid analgesics on the GI tract without blocking their beneficial analgesic effects.
The drug has been delayed due to safety concerns by the FDA. The agency requested data from clinical trials studying Entereg in patients with cancer pain and opioid-induced bowel dysfunction, as well as results from trials testing the drug in combination with hydrocodone and acetaminophen and two-year carcinogenicity data from preclinical studies.
GSK and Adolor had suspended the drug’s development after safety concerns, including cardiovascular adverse events, skin cancers and bone fractures, surfaced in clinical trials.
The committee will meet Jan. 23, 2008, before the drug’s user fee action date of Feb. 10, 2008.