FDA approves Ironwood’s LINZESS to treat irritable bowel syndrome with constipation

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest Laboratories, Inc. (NYSE: FRX) announced today that LINZESS™ (linaclotide) was approved by the U.S. Food and Drug Administration (FDA) as a once-daily treatment for adult men and women suffering from irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC).    

IBS-C and CIC are chronic functional gastrointestinal disorders that affect as many as 13 million and 35 million adult Americans, respectively. Symptoms associated with IBS-C include abdominal pain and constipation; 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," said William D. 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."

Linaclotide, the active ingredient in LINZESS, is a first-in-class guanylate cyclase-C (GC-C) agonist and acts locally in the intestine with minimal systemic exposure. In nonclinical studies, linaclotide has been shown to reduce intestinal pain and accelerate gastrointestinal transit. Linaclotide-induced intestinal pain reduction is thought to result from an increase in cyclic guanosine monophosphate (cGMP), which has been shown to decrease the activity of pain-sensing nerves.

In placebo-controlled Phase III clinical trials of more than 2,800 adults, LINZESS was shown to significantly reduce abdominal pain in IBS-C patients and significantly increase bowel movement frequency in both IBS-C patients and CIC patients. Improvements were reported in the first week of treatment and maintained throughout the treatment period. When a subset of LINZESS-treated patients in the trials were switched to placebo, they reported their symptoms returned toward pretreatment levels within one week, while placebo-treated patients switched to LINZESS reported symptom improvements. LINZESS has not been studied in pediatric patients. LINZESS is contraindicated in pediatric patients up to 6 years of age. The use of LINZESS in pediatric patients 6 through 17 years of age should be avoided.

Ironwood and Forest expect LINZESS to be available 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," said Peter Hecht, Chief Executive Officer of Ironwood. "As Ironwood's first FDA-approved drug, LINZESS represents significant progress towards achieving our goals of delivering medicines to patients and value to shareholders."

Howard Solomon, Chairman, Chief Executive Officer and President of Forest Laboratories, said: "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."