[May 17, 2016] |
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Ironwood Pharmaceuticals to Present Linaclotide Data at Digestive Disease Week® 2016
Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced the
presentation of linaclotide-related clinical and preclinical data from
the company and its collaborators during Digestive Disease Week® (DDW)
2016 in San Diego, CA (News - Alert), May 21 through May 24, 2016.
The data will be presented via oral and poster presentations as follows:
Insights into GC-C Expression in IBS-C (Oral Presentation):
Guanylate Cyclase-C Expression Is Down-Regulated in Colonic Biopsies
From Female Irritable Bowel Syndrome Patients With Constipation (session
ID #366), by Stuart Brierley, Ph.D., Associate Professor and Head
of the Visceral Pain Group, Discipline of Medicine at the University of
Adelaide, et al., will be presented at the Diagnosis and Advances in
Understanding and Management of IBS session taking place on Sunday, May
22, 2016, 2:36 p.m. to 2:48 p.m. Pacific Time, in Location 33 of the San
Diego Convention Center.
Linaclotide Preclinical Data: Colon and Bladder Potentially Connected
Pathways (Oral and Poster Presentations):
Chronic Oral Administration of the Guanylate Cyclase-C Agonist
Linaclotide Attenuates Colitis Induced Bladder Afferent Hyperactivity (session
ID #561), by Luke A. Grundy, Ph.D., Postdoctoral Fellow,
University of Adelaide, et al., will be presented at the Receptors and
Enteric Neurosciences session taking place on Monday, May 23, 2016, 8:15
a.m. to 8:30 a.m. Pacific Time, in Location 29 CD of the San Diego
Convention Center.
Linaclotide Attenuates Visceral Organ CrossTalk: Importance of
Guanylate Cyclase C (GC-C) Activation in Improving Colonic
Hyperpermeability Induced by Protamine Sulfate Infusion Into the Bladder (poster
ID #Mo1315), by Ehsan Mohammadi, B.Sc., Senior Research Associate,
University of Oklahoma College of Medicine, et al., will be presented at
the Probiotics/Novel Therapeutics in Intestinal Disease (III) session
taking place on Monday, May 23, 2016, 9:30 a.m. to 4 p.m. Pacific Time,
in Hall C of the San Diego Convention Center.
Clinical Data on Linaclotide in Patients with IBS-C from China and
Japan (Poster Presentations):
Determining an Optimal Dose of Linaclotide in Use in Japanese
Patients With Irritable Bowel Syndrome With Constipation: A Phase II
Randomized, Double-Blind, Placebo-Controlled Study (poster ID
#Mo1626), by Shin Fukudo, Ph.D., Professor and Director of Behavioral
Medicine, Tohoku University, et al., will be presented at the IBS:
Clinical session taking place on Monday, May 23, 2016, 9:30 a.m. to 4
p.m. Pacific Time, in Hall C of the San Diego Convention Center.
Efficacy and Safety of Linaclotide in Patients with IBS-C: Results
from a Phase 3, Randomized, Double-blind, Placebo-controlled Trial in
China and Other Regions (poster ID #Mo1646), by Yunsheng
Yang, M.D., Ph.D., Professor, Department of Gastroenterology and
Hepatology, Chinese PLA General Hospital, et al., will be presented at
the IBS: Clinical session taking place on Monday, May 23, 2016, 9:30
a.m. to 4 p.m. Pacific Time, in Hall C of the San Diego Convention
Center.
About Linaclotide Linaclotide is a guanylate cyclase-C
(GC-C) agonist that is thought to work in two ways based on nonclinical
studies. Linaclotide binds to the GC-C receptor locally, within the
intestinal epithelium. Activation of GC-C results 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. Linaclotide is marketed by Ironwood and Allergan
plc in the United States as LINZESS® and is indicated for the treatment
of adults with irritable bowel syndrome with constipation (IBS-C) or
chronic idiopathic constipation (CIC), with more than 1 million unique
patients in the U.S. having filled more than 4.5 million linaclotide
prescriptions since launch, according to IMS Health. Linaclotide is
marketed by Allergan for the treatment of adults with moderate to severe
IBS-C in Europe under the brand name CONSTELLA®. Ironwood also has
partnered with Astellas for development and commercialization of
linaclotide in Japan and with AstraZeneca for development and
commercialization in China.
About Ironwood Pharmaceuticals Ironwood
Pharmaceuticals (NASDAQ: IRWD) is a commercial biotechnology company
focused on creating medicines that make a difference for patients,
building value for our fellow shareholders, and empowering our
passionate team. We are advancing an innovative pipeline of medicines in
multiple areas of significant unmet need, including irritable bowel
syndrome with constipation (IBS-C)/chronic idiopathic constipation
(CIC), vascular and fibrotic diseases, and refractory gastroesophageal
reflux disease, among others. We discovered, developed and are
commercializing linaclotide, the U.S. branded prescription market leader
in the IBS-C/CIC category, and we are applying our proven R&D and
commercial capabilities to advance multiple internally-developed and
externally-accessed product opportunities. Ironwood was founded in 1998
and is headquartered in Cambridge, Mass. For more information, please
visit www.ironwoodpharma.com
or www.twitter.com/ironwoodpharma;
information that may be important to investors will be routinely posted
in both these locations.
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LINZESS Important Safety Information
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WARNING: PEDIATRIC RISK
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LINZESS is contraindicated in pediatric patients under 6 years of
age. In nonclinical
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studies, administration of a single, clinically relevant adult
oral dose of linaclotide
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caused deaths due to dehydration in young juvenile mice. Use of
LINZESS should be avoided in
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pediatric patients 6 through 17 years of age. The safety and
efficacy of LINZESS has not
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been established in pediatric patients under 18 years of age.
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Contraindications
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LINZESS is contraindicated in pediatric patients under 6 years of age.
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LINZESS is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction.
Warnings and Precautions Pediatric Risk
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LINZESS is contraindicated in children under 6 years of age. The
safety and effectiveness of LINZESS in pediatric patients under 18
years of age have not been established. In neonatal mice, increased
fluid secretion as a consequence of GC-C agonism resulted in mortality
within the first 24 hours due to dehydration. Due to increased
intestinal expression of GC-C, children under 6 years of age may be
more likely than older children and adults to develop significant
diarrhea and its potentially serious consequences.
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Use of LINZESS should be avoided in pediatric patients 6 through 17
years of age. 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
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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.
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Patients should be instructed to stop LINZESS if severe diarrhea
occurs and to contact their healthcare provider. The healthcare
provider should consider dose suspension and rehydration.
Adverse Reactions
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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%).
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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%).
Please see full Prescribing Information including Boxed Warning: http://www.frx.com/pi/linzess_pi.pdf.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160517005213/en/
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