Ironwood and Forest Announce U.S. Availability of LINZESS™ (Linaclotide)
December 17 2012 - 8:00AM
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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