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Lower dose Linzess effective for chronic idiopathic constipation
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Ironwood and Allergan announced they will submit a supplemental new drug application to the FDA in the first half of 2016 for a 72 mcg dose of Linzess for chronic idiopathic constipation following positive phase 3 clinical trial results.
Linzess (linaclotide, Ironwood), a guanylate cyclase-C agonist designed to increase secretion of intestinal fluid to accelerate transit and decrease the activity of intestinal pain-sensing nerves, is currently FDA approved at a once-daily dose of 145 mcg for adults with chronic idiopathic constipation (CIC), and at a once-daily dose of 290 mcg for adults with constipation-predominant irritable bowel syndrome (IBS-C), according to a press release.
“Linaclotide is the branded prescription market leader in the treatment of IBS-C and CIC, and we believe the availability of a 72 mcg dose could enhance its utility to physicians for use across the broad, heterogeneous CIC patient population, which encompasses some 35 million adult Americans,” Tom McCourt, chief commercial officer at Ironwood, said in the press release. “With the successful completion of this trial, linaclotide has met all primary endpoints in all seven of its phase 3 trials — spanning three doses and two indications. We are committed to continuing to innovate with this molecule, and we are developing multiple additional indications and formulations that, if approved, can address a broad spectrum of patient needs.”
In this randomized, double-blind, placebo-controlled, multicenter trial, 1,223 adults with CIC were randomly assigned to receive once daily 72 mcg linaclotide, 145 mcg linaclotide or placebo for 12 weeks. The 72 mcg dose significantly increased complete spontaneous bowel movement (CSBM) frequency compared with placebo on the trial’s overall responder endpoint (≥ 3 CSBMs/week plus an increase of ≥1 CSBM from baseline in the same week for 9 out of 12 weeks) and the trial’s durable responder endpoint (weekly responder criteria for ≥ 3 of the last 4 weeks), which is currently being requested by the FDA for phase 3 CIC trials. Both doses were generally well tolerated, and the most common adverse event was mild diarrhea, according to the press release.
Disclosures: McCourt reports he is an employee of Ironwood.