FDA approves 72 mcg dose of Linzess for chronic idiopathic constipation

CAMBRIDGE, Mass., and DUBLIN — The U.S. Food and Drug Administration approved Allergan and Ironwood Pharmaceutical’s Linzess (linaclotide) 72 mcg dose for the treatment of chronic idiopathic constipation in adult patients. The newly approved does is expected to available in the first quarter of this year.

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.

The approval of Linzess 72 mcg is based on results from a Phase III clinical trial of 1,223 adults with CIC.

“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,” said Tom McCourt, chief commercial officer at Ironwood.

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.

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.” 

Chronic idiopathic constipation is a functional gastrointestinal disorder estimated to impact as many as 35 million adult Americans.