FDA OK’s Ironwood/Allergan’s constipation drug

FDA OK’s Ironwood/Allergan’s constipation drug

January 26, 2017 Off By Dino Mustafić

Ironwood Pharmaceuticals and Allergan have won U.S. Food and Drug Administration’s (FDA) approval for 72 mcg dose of Linzess (linaclotide) for the treatment of chronic idiopathic constipation (CIC) in adult patients.

According to the press release from Ironwood, the new dose will be available on market in the first quarter of 2017. Besides that, two more dosages will be available adult patients with irritable bowel syndrome with constipation (IBS)(290 mcg) and with CIC (and 145 mcg and a new 72 mcg).

Since the launch of Linzess in December of 2012, nearly 1.5 million unique patients have filled nearly 7 million prescriptions, the company said in its press release issued on Thursday.

“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.