GlaxoSmithKline and Adolor Corporation has provided an update on the alvimopan (Entereg/Entrareg) development programme.
The US Food and Drug Administration (FDA) has requested that additional data be submitted as part of the complete response to the November 6, 2006 approvable letter for alvimopan in postoperative ileus (POI). These 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 alvimopan (alvimopan/hydrocodone/APAP), study 228, as part of the complete response. Adolor has discontinued study 228 to enable final data collection and analysis.
The FDA has placed the alvimopan Investigational New Drug Applications (INDs) on clinical hold pending submission and analysis of the requested information and notification by the FDA that clinical studies with alvimopan may resume. GSK and Adolor currently have no studies ongoing with alvimopan.
"We are working closely with GSK to complete analyses of these studies and satisfy all requests for data for our complete response," said Michael R Dougherty, president and chief executive officer of Adolor. "We now expect that this submission will occur in the third quarter of 2007."
GSK anticipates providing an update on the development plan for alvimopan in OBD in the third quarter of 2007.