Ironwood Pharmaceuticals, Inc. and Allergan plc announced that the U.S. Food and Drug Administration has approved a 72 mcg dose of LINZESS (linaclotide) for the treatment of chronic idiopathic constipation in adult patients. The newly approved dose will provide physicians with dosing flexibility based on individual presentation or tolerability, in treating the large and heterogenous population of adult CIC patients. The new dose is expected to be available in the first quarter of 2017. LINZESS is now FDA-approved in three dosage strengths: 290 mcg for adult patients with irritable bowel syndrome with constipation (IBS-C), and 145 mcg and a new 72 mcg for the treatment of adults with CIC. Since the launch of LINZESS in December of 2012, nearly 1.5 million unique patients have filled nearly 7 million prescriptions, according to IMS Health data. The approval of LINZESS 72 mcg is based on results from a Phase III clinical trial of 1,223 adults with CIC. As previously reported, this trial met its primary endpoint; the 72mcg dose demonstrated statistically significant improvement in Complete Spontaneous Bowel Movements compared to placebo over 12 weeks. The most common adverse event was diarrhea; the rates of diarrhea and of discontinuations due to diarrhea were numerically lower for the 72 mcg dose than the 145 mcg dose in this trial. LINZESS has met all primary endpoints in each of its five pivotal U.S. Phase III trials, spanning three doses and two indications.