Ironwood, Forest, and Almirall confirm plans to file for approval in U.S. and EU by late 2011.
The irritable bowel syndrome (IBS) candidate linaclotide provided patients suffering from IBS and constipation (IBS-C) with significant relief from abdominal pain, discomfort, and associated symptoms, according to Phase III data reported by the drug’s developer, Ironwood Pharmaceuticals, and its respective U.S. and European partners, Forest Laboratories and Almirall. The two U.S.-based firms say they expect to submit a linaclotide NDA to FDA for both IBS-C and chronic constipation indications in the third quarter of calendar year 2011. A regulatory filing for linaclotide by Almirall in Europe is also expected during the second half of 2011.
The placebo-controlled 26-week MCP-103-203 trial included 805 patients with IBS and constipation (IBS-C). The results found that 39.4% of linaclotide-treated patients, but only 16.6% of placebo-treated patients, reported either considerable or complete relief from IBS symptoms for at least six of the first 12 weeks of study. 54.1% of linaclotide patients also reported improvements of 30% or more from baseline in either mean abdominal pain score or mean abdominal discomfort score, for at least six of the first 12 weeks. This compared with 38.5% of placebo patients. Linaclotide therapy in addition resulted in significant improvements in complete spontaneous bowel movements (CSBMs).
All main secondary endpoints in the trial were also met, and linaclotide therapy resulted in significant improvements from baseline with respect to abdominal pain and CSBMs, at each of the 26 weeks of the treatment period. “Linaclotide’s effect on these symptoms and tolerability profile has been remarkably consistent across the robust IBS-C and chronic constipation development program,” says Peter Hecht, Ironwood CEO.
Ironwood and Forest have previously reported positive results from the first of two Phase III trials in patients with IBS-C, and two Phase III trials in patients with chronic constipation The IBS-C trials were also designed to support regulatory submission in Europe.