Regulatory Affairs

FDA approves 72 mcg dose of LINZESS for adults with chronic idiopathic constipation

Published 27 January 2017

The US Food and Drug Administration (FDA) has approved a 72 mcg dose of Ironwood Pharmaceuticals' LINZESS(linaclotide) for the treatment of chronic idiopathic constipation (CIC) 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.1

Tom McCourt, Chief Commercial Officer at Ironwood, said: "LINZESS is the branded prescription market leader in the treatment of adult patients with IBS-C or CIC, and we believe the availability of a 72 mcg dose will enhance the product's utility to physicians in treating patients across the broad CIC patient population, which encompasses up to 35 million adult Americans."

Bill Meury, Chief Commercial Officer at Allergan, said, "This approval is testimony to the ongoing commitment of our organizations to continue to innovate with LINZESS and to enhance patient care and refine the treatment of gastrointestinal disorders such as CIC."

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.

Source: Company Press Release