Ironwood Pharma's linaclotide successful in late-stage CIC study at half the approved dose; sNDA planned for H1; shares up 4% after hours

• A Phase 3 clinical trial evaluating Ironwood Pharmaceuticals' (NASDAQ:IRWD) linaclotide at a dose of 72 mcg for the treatment of adults with chronic idiopathic constipation (CIC) met its primary objective of a statistically significant improvement versus placebo on the 12-week Complete Spontaneous Bowel Movements (CSBM) Overall Responder endpoint. In addition, the 72 mcg dose demonstrated statistically significant improvement compared to placebo on the Durable CSBM Overall Responder endpoint, currently being requested by the FDA for Phase 3 CIC studies.
• Linoclotide, marketed under the brand name Linzess, was originally cleared by the FDA in August 2012 for the  treatment of CIC at a daily dose of 145 mcg and for the treatment of irritable bowel syndrome with constipation at a daily dose of 290 mcg.
• The company and U.S. commercialization partner Allergan (NYSE:AGN) intend to file a supplemental NDA with the FDA in H1 2016.
• IRWD is up 4% after hours on increased volume.