– Data demonstrates that linaclotide reduces
the need for rescue medications in this patient population –
– Additional presentations further characterize
the efficacy and safety profiles of linaclotide as the only
FDA-approved prescription therapy for this patient population –
– Functional constipation affects an estimated
6 million children and adolescents ages 6-17 years-old in the
U.S.1 –
Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a leading global
gastrointestinal healthcare company, will present findings during
the 2023 North American Society for Pediatric Gastroenterology,
Hepatology & Nutrition (NASPGHAN) Annual Meeting demonstrating
that linaclotide decreased the use of rescue medications in
children and adolescents ages 6-17 years-old with functional
constipation. These findings build on previously announced data
from the company’s pivotal Phase III trial, which formed the basis
of a June 2023 Food and Drug Administration (FDA) approval of
linaclotide for the treatment of functional constipation in this
pediatric population.
Functional constipation in children is defined as a condition
with hard, infrequent bowel movements that are often difficult or
painful to pass2. The condition affects an estimated 6 million
children and adolescents ages 6-17 years-old in the U.S.1
The data, which were part of a post-hoc analysis, will be
featured in a poster titled Once-Daily Linaclotide 72 µg Reduces
the Need for Rescue Medication Use in Children with Functional
Constipation (presentation number 465) on Oct. 6 from 12:30 to 1:30
p.m. PDT in the Sapphire Ballroom presented by Tina Shakhnovich,
M.D., pediatric gastroenterologist and Ironwood’s Medical Director
of Clinical Development. The analysis found that approximately half
of the children enrolled in the trial relied on rescue medications
at least once per week for symptom relief. By the end of the
12-week treatment period, the use of rescue medications, which
included senna (oral), bisacodyl (oral or rectal) or sodium
picosulphate (oral), decreased to 8.7 percent of children receiving
linaclotide versus 18.8 percent of children receiving placebo. Over
the entire study period, more children treated with linaclotide
(61.0 percent) experienced a decrease in rescue medication use
compared to those treated with placebo (48.2 percent), and fewer
children treated with linaclotide (15.2 percent) experienced an
increase in rescue medication use compared to those treated with
placebo (26.2 percent; p=0.0095).
“In this clinical trial, participants experiencing an inadequate
therapeutic response or exacerbation of symptoms could use rescue
medications to alleviate their symptoms,” said Jeffrey S. Hyams,
M.D., Head, Division of Digestive Diseases, Hepatology, and
Nutrition, Connecticut Children’s Medical Center, Professor of
Pediatrics, University of Connecticut School of Medicine. “The
decrease we saw in use of rescue medications is additional
important evidence supporting the efficacy of linaclotide in this
patient population.”
Ironwood and its collaborators will present additional data
describing the cumulative treatment effect of linaclotide in this
patient population. Additionally, Ironwood and its partner AbbVie
are sponsoring a medical symposium titled “Managing Pediatric
Constipation” on Oct. 6, 2023 from 6:00 to 8:00 p.m. PDT (Room:
Indigo AE). The symposium, which is not an official NASPGHAN
event/function, will provide meeting attendees with an overview of
pediatric functional constipation, presentation/diagnosis and
management.
“Ironwood is committed to ongoing research and education around
our products and the diseases they treat to ensure deeper
understanding of their impact,” said Michael Shetzline, M.D.,
Ph.D., chief medical officer, senior vice president and head of
research and drug development at Ironwood Pharmaceuticals. “We’re
honored to be at NASPGHAN, reviewing data and information on
pediatric functional constipation with the pediatric GI
community.”
Cumulative Effect of Linaclotide in Children and Adolescents
Ages 6-17 Years-Old with Functional Constipation
- A poster titled Cumulative Treatment Effect of Linaclotide for
Pediatric Functional Constipation: A Phase 3, Randomized,
Double-Blind, Placebo-Controlled Trial (presentation number 729)
will be presented on Oct. 7, 2023 from 12:30 to 1:30 p.m. PDT in
the Sapphire Ballroom by Tina Shakhnovich, M.D. The analysis showed
that a higher proportion of patients in the linaclotide treatment
group versus the placebo consistently achieved improvement at every
responder threshold for increase in spontaneous bowel movement
frequency and achievement of softer post-baseline stool
consistency.
- A poster titled Cumulative Experience with Diarrhea as an
Uncommon Treatment-Emergent Adverse Event in Pediatric Trials of
Linaclotide for the Treatment of Functional Constipation
(presentation number 727) will be presented on Oct. 7, 2023, from
12:30 to 1:30 p.m. PDT in the Sapphire Ballroom by Julie Khlevner,
M.D., Columbia University Vagelos College of Physicians and
Surgeons and New York Presbyterian Morgan Stanley Children’s
Hospital, New York, NY. The post-hoc analysis demonstrated that in
pediatric patients with functional constipation, diarrhea occurred
in 7.4 percent of the linaclotide-treated population and 1.5
percent of those receiving placebo.
About Linaclotide
LINZESS® is the #1 prescribed brand in the U.S. for the
treatment of adult patients with irritable bowel syndrome with
constipation (“IBS-C”) or chronic idiopathic constipation (“CIC”),
based on IQVIA data. LINZESS is a once-daily capsule that helps
relieve the abdominal pain, constipation, and overall abdominal
symptoms of bloating, discomfort and pain associated with IBS-C, as
well as the constipation, infrequent stools, hard stools,
straining, and incomplete evacuation associated with CIC. LINZESS
relieves constipation in children and adolescents aged 6 to 17
years with functional constipation. The recommended dose is 290 mcg
for IBS-C patients and 145 mcg for CIC patients, with a 72 mcg dose
approved for use in CIC depending on individual patient
presentation or tolerability. In children with functional
constipation aged 6 to 17 years, the recommended dose is 72
mcg.
LINZESS is not a laxative; it is the first medicine approved by
the FDA in a class called GC-C agonists. LINZESS contains a peptide
called linaclotide that activates the GC-C receptor in the
intestine. Activation of GC-C is thought to result in increased
intestinal fluid secretion and accelerated transit and a decrease
in the activity of pain-sensing nerves in the intestine. The
clinical relevance of the effect on pain fibers, which is based on
nonclinical studies, has not been established.
In the United States, Ironwood and AbbVie co-develop and
co-commercialize LINZESS for the treatment of adults with IBS-C or
CIC. In Europe, AbbVie markets linaclotide under the brand name
CONSTELLA® for the treatment of adults with moderate to severe
IBS-C. In Japan, Ironwood's partner, Astellas, markets linaclotide
under the brand name LINZESS for the treatment of adults with IBS-C
or CIC. Ironwood also has partnered with AstraZeneca for
development and commercialization of LINZESS in China, and with
AbbVie for development and commercialization of linaclotide in all
other territories worldwide.
LINZESS Important Safety Information
INDICATIONS AND USAGE
LINZESS (linaclotide) is indicated in adults for the treatment
of both irritable bowel syndrome with constipation (IBS-C) and
chronic idiopathic constipation (CIC) and functional constipation
(FC) in children and adolescents 6 to 17 years of age. It is not
known if LINZESS is safe and effective in children with FC less
than 6 years of age or in children with IBS-C less than 18 years of
age.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DEHYDRATION IN
PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE
LINZESS is contraindicated in patients
less than 2 years of age. In nonclinical studies in neonatal mice,
administration of a single, clinically relevant adult oral dose of
linaclotide caused deaths due to dehydration.
Contraindications
- LINZESS is contraindicated in patients less than 2 years of age
due to the risk of serious dehydration.
- LINZESS is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction.
Warnings and Precautions
- LINZESS is contraindicated in patients less than 2 years of
age. In neonatal mice, linaclotide increased fluid secretion as a
consequence of age-dependent elevated guanylate cyclase (GC-C)
agonism, which was associated with increased mortality within the
first 24 hours due to dehydration. There was no age dependent trend
in GC-C intestinal expression in a clinical study of children 2 to
less than 18 years of age; however, there are insufficient data
available on GC-C intestinal expression in children less than 2
years of age to assess the risk of developing diarrhea and its
potentially serious consequences in these patients.
Diarrhea
- In adults, diarrhea was the most common adverse reaction in
LINZESS-treated patients in the pooled IBS-C and CIC double-blind
placebo-controlled trials. The incidence of diarrhea was similar in
the IBS-C and CIC populations. Severe diarrhea was reported in 2%
of 145 mcg and 290 mcg LINZESS-treated patients and in <1% of 72
mcg LINZESS-treated CIC patients.
- In children and adolescents 6 to 17 years of age, diarrhea was
the most common adverse reaction in 72 mcg LINZESS-treated patients
in the FC double-blind placebo-controlled trial. Severe diarrhea
was reported in <1% of 72 mcg LINZESS treated patients. If
severe diarrhea occurs, dosing should be suspended and the patient
rehydrated.
Common Adverse Reactions (incidence ≥2% and greater than
placebo)
- In IBS-C or CIC adult patients: diarrhea, abdominal pain,
flatulence, and abdominal distension.
- In FC pediatric patients: diarrhea.
Please see full Prescribing Information including Boxed Warning:
http://www.allergan.com/assets/pdf/linzess_pi
LINZESS® and CONSTELLA® are registered trademarks of Ironwood
Pharmaceuticals, Inc. Any other trademarks referred to in this
press release are the property of their respective owners. All
rights reserved.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (Nasdaq: IRWD), an S&P SmallCap
600® company, is a leading global gastrointestinal (GI) healthcare
company on a mission to advance the treatment of GI diseases and
redefine the standard of care for GI patients. We are pioneers in
the development of LINZESS® (linaclotide), the U.S. branded
prescription market leader for adults with irritable bowel syndrome
with constipation (IBS-C) or chronic idiopathic constipation (CIC).
LINZESS is also approved for the treatment of functional
constipation in pediatric patients ages 6-17 years-old. Ironwood is
also advancing apraglutide, a next-generation, long-acting
synthetic GLP-2 analog being developed for rare gastrointestinal
diseases, including short bowel syndrome with intestinal failure
(SBS-IF) as well as several earlier stage assets. Building upon our
history of GI innovation, we keep patients at the heart of our
R&D and commercialization efforts to reduce the burden of GI
diseases and address significant unmet needs.
Founded in 1998, Ironwood Pharmaceuticals is headquartered in
Boston, Massachusetts, and has additional operations in Basel,
Switzerland.
We routinely post information that may be important to investors
on our website at www.ironwoodpharma.com. In addition, follow us on
Twitter and on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements.
Investors are cautioned not to place undue reliance on these
forward-looking statements, including statements about the
potential of linaclotide for children and adolescents ages 6-17
years-old with functional constipation; the efficacy and safety
profiles of linaclotide in this pediatric patient population; the
size of the pediatric population affected by functional
constipation. These forward-looking statements speak only as of the
date of this press release, and Ironwood undertakes no obligation
to update these forward-looking statements. Each forward-looking
statement is subject to risks and uncertainties that could cause
actual results to differ materially from those expressed or implied
in such statement. Applicable risks and uncertainties include those
related to the effectiveness of development and commercialization
efforts by us and our partners; preclinical and clinical
development, manufacturing and formulation development of
linaclotide and our product candidates; the risk that clinical
programs and studies may not progress or develop as anticipated,
including that studies are delayed or discontinued for any reason,
such as safety, tolerability, enrollment, manufacturing, economic
or other reasons; the risk that findings from our completed
nonclinical and clinical studies may not be replicated in later
studies; the risk that we or our partners are unable to obtain,
maintain or manufacture sufficient LINZESS or our product
candidates, or otherwise experience difficulties with respect to
supply or manufacturing; the efficacy, safety and tolerability of
linaclotide and our product candidates; the risk that the
therapeutic opportunities for LINZESS or our product candidates are
not as we expect; decisions by regulatory and judicial authorities;
the risk we may never get additional patent protection for
linaclotide and other product candidates, that patents for
linaclotide or other products may not provide adequate protection
from competition, or that we are not able to successfully protect
such patents; outcomes in legal proceedings to protect or enforce
the patents relating to our products and product candidates,
including abbreviated new drug application litigation; the risk
that financial and operating results may differ from our
projections; developments in the intellectual property landscape;
challenges from and rights of competitors or potential competitors;
developments in accounting guidance or practice; Ironwood’s or
AbbVie’s accounting practices, including reporting and settlement
practices as between Ironwood and AbbVie; the risk that we are
unable to manage our expenses or cash use, or are unable to
commercialize our products as expected; and the risks listed under
the heading “Risk Factors” and elsewhere in our Annual Report on
Form 10-K for the fiscal year ended December 31, 2022, and in our
subsequent SEC filings.
____________________ 1 U.S. Census, 2017 National Population
Projection Tables; Robin, Samantha G. et al, Prevalence of
Pediatric Functional Gastrointestinal Disorders Utilizing the Rome
IV Criteria, The Journal of Pediatrics, December 2017; Koppen, I.
J. N. et al., Prevalence of Functional Defecation Disorders in
Children: A Systemic Review and Meta-Analysis. J Pediatr. 2018. 2
Di Lorenzo C, Hyams JS, Saps M, et al. Chapter 16: Childhood
Functional Gastrointestinal Disorders: Child/Adolescent. In:
Drossman DA, Chang L, Chey WD, et al. Rome IV: Functional
Gastrointestinal Disorders: Disorders of Gut-Brain Interaction.
Raleigh, NC: Rome Foundation; 2016.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231005868701/en/
Media:
Beth Calitri, 978-417-2031 bcalitri@ironwoodpharma.com
Investors:
Greg Martini, 617-374-5230 gmartini@ironwoodpharma.com
Matt Roache, 617-621-8395 mroache@ironwoodpharma.com
Ironwood Pharmaceuticals (NASDAQ:IRWD)
Gráfico Histórico do Ativo
De Jan 2025 até Fev 2025
Ironwood Pharmaceuticals (NASDAQ:IRWD)
Gráfico Histórico do Ativo
De Fev 2024 até Fev 2025
