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FDA Approves Lower Dose Linzess for Chronic Idiopathic Constipation
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The FDA has approved a 72-µg dose of Linzess for adults with chronic idiopathic constipation, which Ironwood and Allergan expect to be available in the first quarter of 2017, the companies announced.
“Linzess [linaclotide, Ironwood/Allergan] 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-µg 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,” Tom McCourt, chief commercial officer at Ironwood, said in a press release.
Approval of the lower dose of linaclotide follows phase 3 trial results involving 1,223 adults with CIC. The trial met its primary endpoint, with significant improvements in complete spontaneous bowel movements achieved with 72 µg linaclotide vs. placebo over 12 weeks. Diarrhea was the most frequent adverse event, and the 72-µg group showed lower rates of diarrhea and discontinuations due to diarrhea compared with the 145-µg dose in the trial.
“Linzess has met all primary endpoints in each of its five pivotal U.S. phase 3 trials, spanning three doses and two indications,” according to the press release. “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.”
Linaclotide was the first guanylate cyclase-C agonist approved by the FDA, and is now approved in a 290 µg dose for adults with IBS-C, and 145 µg and 72 µg doses for adults with CIC. It is marketed as Constella in Europe and Canada, and Ironwood has partnered with AstraZeneca to develop and commercialize it in China.
Disclosures: McCourt is employed by Ironwood.