- New Treatment for Adults with Irritable Bowel Syndrome with
Constipation or Chronic Idiopathic Constipation Now in Pharmacies Across
the U.S.-
CAMBRIDGE, Mass. & NEW YORK--(BUSINESS WIRE)--
Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest
Laboratories, Inc. (NYSE: FRX) announced today that LINZESS™
(linaclotide) is now available in pharmacies throughout the United
States. The U.S. Food and Drug Administration (FDA) recently approved
LINZESS as a once-daily oral capsule for adult men and women suffering
from irritable bowel syndrome with constipation (IBS-C) or chronic
idiopathic constipation (CIC).
LINZESS is the first and only FDA-approved guanylate cyclase-C (GC-C)
agonist and acts locally in the intestine. For the first time in over
six years, a new prescription option is available for adults with these
disorders.
Visit www.linzess.com
for more information about LINZESS.
About LINZESS
LINZESS is the first and only guanylate cyclase-C (GC-C) agonist
approved by the FDA for the treatment of both irritable bowel syndrome
with constipation (IBS-C) and chronic idiopathic constipation (CIC) in
adults. LINZESS is a once-daily capsule that helps relieve the abdominal
pain and constipation associated with IBS-C and constipation and hard
stools associated with CIC. The recommended dose is 290 mcg for IBS-C
patients and 145 mcg for CIC patients. LINZESS should be taken at least
30 minutes before the first meal of the day.
LINZESS is thought to work in two ways based on nonclinical studies.
LINZESS binds to the GC-C receptor locally, within the intestinal
epithelium. Activation of GC-C results in increased intestinal fluid
secretion and transit and a reduction in visceral pain, which is thought
to be mediated by decreased activity of pain-sensing nerves. The
clinical relevance of the effect on pain fibers in nonclinical studies
has not been established.
In placebo-controlled Phase III clinical trials of more than 2,800
adults, LINZESS was shown to reduce abdominal pain in IBS-C patients and
increase bowel movement frequency in both IBS-C patients and CIC
patients. Improvement in abdominal pain and constipation occurred in the
first week of treatment and was maintained throughout the 12-week
treatment period. Maximum effect on abdominal pain was seen at weeks 6-9
and maximum effect on constipation occurred during the first week. 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 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. In nonclinical
studies, administration of a single, clinically relevant adult oral dose
of linaclotide caused deaths in young juvenile mice. LINZESS has not
been studied in pediatric patients. In adults with IBS-C or CIC treated
with LINZESS, the most commonly reported adverse event was diarrhea.
Ironwood and Forest are co-promoting LINZESS in the United States.
Linaclotide was also approved recently by the European Commission for
the treatment of adults in the European Union with IBS-C and will be
marketed under the brand name Constella® through a license agreement
between Ironwood and Almirall, S.A. Ironwood also has partnered
linaclotide with Astellas Pharma Inc. for development and
commercialization in Japan and certain other Asian countries and with
AstraZeneca for development and commercialization in China.
About Irritable Bowel Syndrome with Constipation
Irritable bowel syndrome with constipation (IBS-C) is a chronic
functional gastrointestinal disorder that affects as many as 13 million
people in the United States. IBS-C can have a negative impact on daily
living; patients often experience recurring abdominal pain or
discomfort, constipation, and bowel symptoms including hard or lumpy
stools in more than 25% of bowel movements, and soft or watery stools in
less than 25% of bowel movements. There are currently few available
therapies approved to treat this disorder.
About Chronic Idiopathic Constipation
Chronic idiopathic constipation (CIC) is a functional gastrointestinal
disorder in which individuals experience infrequent bowel movements
(less than three times per week) for at least three months. Patients who
suffer from CIC may also experience a sensation of incomplete evacuation
and hard stools. As many as 35 million Americans may suffer from
symptoms associated with CIC.
Important Safety Information
WARNING: PEDIATRIC RISK
|
LINZESS is contraindicated in pediatric patients up to 6 years
of age. Use should be avoided in pediatric patients 6 through 17
years of age. In nonclinical studies, administration of a single,
clinically relevant adult oral dose of linaclotide caused deaths
in young juvenile mice.
|
Contraindications
-
LINZESS is contraindicated in pediatric patients up to 6 years of age.
-
LINZESS is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction.
Warnings and Precautions
Pediatric Risk
-
LINZESS is contraindicated in pediatric patients up to 6 years of age.
In nonclinical studies, deaths occurred within 24 hours in young
juvenile mice (1 to 3 week-old mice; approximately equivalent to human
pediatric patients less than 2 years of age) following administration
of one or two daily oral doses of linaclotide.
-
Use of LINZESS should be avoided in pediatric patients 6 through 17
years of age. Linaclotide did not cause deaths in older juvenile mice
(approximately equivalent to humans age 12 to 17 years). Although
there were no deaths in older juvenile mice, given the deaths in young
juvenile mice and the lack of clinical safety and efficacy data in
pediatric patients, use of LINZESS should be avoided in pediatric
patients 6 through 17 years of age.
Diarrhea
-
Diarrhea was the most common adverse reaction of LINZESS-treated
patients in the pooled IBS-C and CIC double-blind placebo-controlled
trials. Severe diarrhea was reported in 2% of LINZESS-treated
patients. The incidence of diarrhea was similar in the IBS-C and CIC
populations.
-
Patients should be instructed to stop LINZESS if severe diarrhea
occurs and to contact their healthcare provider, who should consider
dose suspension.
Adverse Reactions
-
In IBS-C clinical trials, the most common adverse reactions in
LINZESS-treated patients (incidence ≥2% and greater than placebo) were
diarrhea (20% vs 3% placebo), abdominal pain (7% vs 5%), flatulence
(4% vs 2%), headache (4% vs 3%), viral gastroenteritis (3% vs 1%) and
abdominal distension (2% vs 1%).
-
In CIC clinical trials, the most common adverse reactions in
LINZESS-treated patients (incidence ≥2% and greater than placebo) were
diarrhea (16% vs 5% placebo), abdominal pain (7% vs 6%), flatulence
(6% vs 5%), upper respiratory tract infection (5% vs 4%), sinusitis
(3% vs 2%) and abdominal distension (3% vs 2%).
Drug Interactions
No drug-drug interaction studies have been conducted with LINZESS.
Linaclotide and its active metabolite are not measurable in plasma
following administration of the recommended clinical doses; hence, no
systemic drug-drug interactions or drug interactions mediated by plasma
protein binding of linaclotide or its metabolite are anticipated
Linaclotide does not interact with the cytochrome P450 enzyme system
based on the results of in vitro studies. In addition, linaclotide is
neither a substrate nor an inhibitor of the efflux transporter
P-glycoprotein (P-gp).
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is an entrepreneurial
pharmaceutical company dedicated to the art and science of great
drugmaking. Ironwood is located in Cambridge, Mass. To learn more, visit www.ironwoodpharma.com.
About Forest Laboratories, Inc.
Forest Laboratories' (NYSE: FRX) longstanding global partnerships and
track record developing and marketing pharmaceutical products in the
United States have yielded its well-established central nervous system
and cardiovascular franchises and innovations in anti-infective and
respiratory, gastrointestinal, and pain management medicine. The
Company's pipeline, the most robust in its history, includes product
candidates in all stages of development across a wide range of
therapeutic areas. The Company is headquartered in New York, NY. To
learn more, visit www.FRX.com.
Except for the historical information contained herein, this release
contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve a
number of risks and uncertainties, including the potential sales of
LINZESS in the United States and of Constella in the European Union, the
target patient populations in the United States for LINZESS, the
potential reimbursement for LINZESS in the United States, the post
approval development strategy for LINZESS, the acceptance and demand for
new pharmaceutical products, the impact of competitive products and
pricing, the timely development and launch of new products, and the risk
factors listed from time to time in each of Forest's and Ironwood's
Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and other
SEC filings. Neither Forest nor Ironwood undertakes any obligation to
update these forward-looking statements to reflect events or
circumstances occurring after this press release. These forward-looking
statements speak only as of the date of this press release. All
forward-looking statements are qualified in their entirety by this
cautionary statement.
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Forest Laboratories, Inc.
Frank J. Murdolo, 212-224-6714
Vice
President - Investor Relations
media.relations@frx.com
or
Ironwood
Pharmaceuticals, Inc.
Media Relations:
Lisa Buffington,
617-374-5103
lbuffington@ironwoodpharma.com
or
Investor
Relations:
Meredith Kaya, 617-374-5082
mkaya@ironwoodpharma.com
Source: Forest Laboratories, Inc. & Ironwood Pharmaceuticals, Inc.
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