Smaller Dose for Constipation Med Approved

The US Food and Drug Administration has approved a 72 mcg dose of LINZESS® (linaclotide; Allergen) for the treatment of chronic idiopathic constipation (CIC) in adult patients.

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The approval was based on results from a phase III clinical trial of 1223 patients with CIC in which those who were treated with linaclotide 75 mcg achieved statistically significant improvement in Complete Spontaneous Bowel Movements compared with a placebo over 12 weeks. The additional dosage means that linaclotide is now available in three forms: 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 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 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.

The most common adverse event experienced by patients who received linaclotide was diarrhea. Rates of diarrhea and of discontinuations due to diarrhea were numerically lower for the 72 mcg dose than the 145 mcg in clinical trials.

CIC affects as many as 35 million adult Americans and is generally characterized infrequent bowel movements (less than three times per week), but symptoms vary across this broad and heterogeneous patient population and may also include recurrent straining, lumpy or hard stools, and/or a sensation that the bowels are not fully empty. Linaclotide is one of the few therapies available to treat the condition.  

Ironwood Pharmaceuticals, Inc., and Allergen plc are co-promoting Linzess in the United States and Mexico.--Sean McGuire

Reference

U.S. Food and Drug Administration Approves 72 mcg Dose of LINZESS® (linaclotide) for Adults with Chronic Idiopathic Constipation [press release]. Cambridge, MA: PR Newswire; January 26, 2017. https://finance.yahoo.com/news/u-food-drug-administration-approves-120100169.html. Accessed January 26,2017.