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CAMBRIDGE, Mass., and NEW YORK — Ironwood Pharmaceuticals Inc. and Forest Laboratories Inc. have received approval from the Food and Drug Administration for Linzess, a medication for irritable bowel syndrome (IBS).
Linzess (linaclotide) is a once-daily treatment for adult men and women suffering from irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC).
Ironwood and Forest said late Thursday that they expect Linzess to ship in the fourth quarter of 2012.
"The discovery of Linzess by Ironwood scientists, and the development work done together by Ironwood and our partner Forest, has resulted in a new medicine with the potential to improve the lives of millions of highly symptomatic IBS-C and CIC patients," stated Peter Hecht, chief executive officer of Ironwood. "As Ironwood’s first FDA-approved drug, Linzess represents significant progress toward achieving our goals of delivering medicines to patients and value to shareholders."
Howard Solomon, chairman and CEO Forest Laboratories, commented, "The approval of Linzess validates Forest and Ironwood’s commitment to bringing forth an effective treatment in disease categories that previously had limited treatment options. We look forward to making this treatment available to the millions of adults with IBS-C and CIC in the United States. This achievement is the result of our close working relationship with Ironwood over the past five years in the development of this exciting product."
IBS-C and CIC are chronic functional gastrointestinal disorders that affect as many as 13 million and 35 million U.S. adults, respectively, the pharmaceutical companies reported. Symptoms of IBS-C include abdominal pain and constipation, while symptoms associated with CIC include constipation (infrequent stools, hard stools and incomplete evacuation).
There are few treatment options for these conditions, particularly options that relieve abdominal pain associated with IBS-C.
"The symptoms experienced by patients with IBS-C and chronic idiopathic constipation can have a significant impact on affected individuals," stated William Chey, M.D., professor of gastroenterology at the University of Michigan Health System. "The approval of Linzess provides physicians with a new, evidence-based, effective treatment option for their adult patients with IBS-C and chronic idiopathic constipation."
