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
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.