Ironwood Pharmaceuticals, Inc. IRWD announced that the 72 mcg dose of linaclotide (U.S. trade name – Linzess; EU trade name – Constella) achieved the primary endpoint in a phase III study being evaluated for the treatment of adults suffering from chronic idiopathic constipation (CIC).
Results from the randomized, double-blind, placebo-controlled study (n=1,223) showed that patients when treated with Linzess (72 mcg) demonstrated a statistically significant improvement compared to placebo on the 12-week complete spontaneous bowel movements (CSBM) overall responder endpoint, thereby meeting the primary endpoint of the study. In addition, a pre-specified sensitivity analysis demonstrated a statistically significant improvement compared to placebo on the durable CSBM overall responder endpoint. This is important as the FDA is currently asking for this criteria for phase III CIC studies.
Based on the positive data, Ironwood and its partner, Allergan plc AGN, intend to submit a supplemental new drug application to the FDA in the first half of 2016. We note that Ironwood has an agreement with Allergan for the development and commercialization of Linzess in the U.S.
Presently, two once-daily doses of Linzess – 145 mcg and 290 mcg – are available for the treatment of adults with CIC and irritable bowel syndrome with constipation, respectively.
We are encouraged by the study results. Considering that as many as 35 million people suffer from CIC in the U.S., approval would provide patients with an additional dosing option.
Ironwood is a Zacks Rank #4 (Sell) stock. A couple of better-ranked stocks in the health care sector are AstraZeneca plc AZN and Endo International plc ENDP. Both carry a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Be the first to comment