CAMBRIDGE, Mass. and
DUBLIN, June 9, 2016 /PRNewswire/ -- Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) and Allergan plc (NYSE: AGN)
today announced that the U.S. Food and Drug Administration (FDA)
has accepted for review the supplemental New Drug Application
(sNDA) for the 72 mcg dose of linaclotide for use in the treatment
of adults with chronic idiopathic constipation (CIC). The sNDA for
the 72 mcg dose of linaclotide is based on efficacy and safety data
from a double-blind, placebo-controlled Phase III clinical trial of
1,223 adult patients with CIC. The FDA Prescription Drug User Fee
Act (PDUFA) target action date is expected to occur in early
2017.
If approved by the FDA, the 72 mcg dose of linaclotide would provide an additional treatment option
for adult patients with CIC. Linaclotide is currently approved by
the FDA for the treatment of adults with CIC as a 145 mcg capsule
to be taken once per day. In addition, it is approved for the
treatment of adults with irritable bowel syndrome with constipation
(IBS-C) as a 290 mcg capsule to be taken once per day. Since FDA
approval in December of 2012, more than 1 million unique patients
have filled a prescription for linaclotide, according to IMS
Health.
About Chronic Idiopathic Constipation
Chronic idiopathic constipation (CIC) is a functional
gastrointestinal disorder estimated to impact as many as 35 million
adult Americans. CIC is generally characterized by infrequent bowel
movements (less than three times per week), but symptoms vary
across this broad and heterogeneous patient population and may also
include recurrent straining, lumpy or hard stools, and/or a
sensation that the bowels are not fully empty. Results derived from
responses to a web-based survey commissioned by Allergan and
Ironwood suggest that only 12 percent of adult CIC sufferers are
medically diagnosed. There are few available prescription treatment
options for this condition.
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 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). 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 Pharma
Inc. for development and commercialization of linaclotide in
Japan and with AstraZeneca for
development and commercialization in China.
Important Safety Information
|
WARNING: PEDIATRIC
RISK
|
LINZESS is
contraindicated in pediatric patients under 6 years of age. In
nonclinical studies, administration of a single, clinically
relevant adult oral dose of linaclotide caused deaths due to
dehydration in young juvenile mice. Use of LINZESS should be
avoided in pediatric patients 6 through 17 years of age. The safety
and efficacy of LINZESS has not been established in pediatric
patients under 18 years of age.
|
Contraindications
- LINZESS is contraindicated in pediatric patients under 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 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.
- 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
- 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. The
healthcare provider should consider dose suspension and
rehydration.
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%).
Please see full Prescribing Information including Boxed
Warning: http://www.allergan.com/assets/pdf/linzess_pi
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
a pipeline of innovative medicines in areas of significant unmet
need, including irritable bowel syndrome with constipation
(IBS-C)/chronic idiopathic constipation (CIC), refractory
gastroesophageal reflux disease, uncontrolled gout, and vascular
and fibrotic diseases. 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.
About Allergan
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global
pharmaceutical company and a leader in a new industry model –
Growth Pharma. Allergan is focused on developing, manufacturing and
commercializing innovative branded pharmaceuticals, high-quality
generic and over-the-counter medicines and biologic products for
patients around the world.
Allergan markets a portfolio of best-in-class products that
provide valuable treatments for the central nervous system, eye
care, medical aesthetics, gastroenterology, women's health,
urology, cardiovascular and anti-infective therapeutic categories,
and operates the world's third-largest global generics business,
providing patients around the globe with increased access to
affordable, high-quality medicines. Allergan is an industry leader
in research and development, with one of the broadest development
pipelines in the pharmaceutical industry and a leading position in
the submission of generic product applications globally.
With commercial operations in approximately 100 countries,
Allergan is committed to working with physicians, healthcare
providers and patients to deliver innovative and meaningful
treatments that help people around the world live longer, healthier
lives.
For more information, visit Allergan's website at
www.allergan.com.
This press release contains forward-looking statements.
Investors are cautioned not to place undue reliance on these
forward-looking statements, including statements about the PDUFA
target action date for the 72 mcg dose of linaclotide and the
potential benefits of the 72 mcg dose of linaclotide. 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
commercialization efforts by Ironwood and Allergan; efficacy,
safety and tolerability of linaclotide; decisions by regulatory
authorities; challenges from and rights of competitors or potential
competitors; and those risks listed under the heading "Risk
Factors" and elsewhere in Ironwood's Quarterly Report on Form 10-Q
for the quarter ended March 31, 2016,
Allergan's Annual Report on Form 10-K for the year
ended December 31,
2015 and in the
subsequent SEC filings of
each company. These forward-looking statements (except as otherwise
noted) speak only as of the date of this press release, and
Ironwood and Allergan undertake no obligation to update these
forward-looking statements.
LINZESS and CONSTELLA are trademarks owned by Ironwood
Pharmaceuticals, Inc. Any other trademarks referred to in
this press release are the property of their respective owners. All
rights reserved.
Allergan :
Media Relations: Mark Marmur
862-261-7558
Investor Relations: Lisa DeFrancesco
862-261-7152
Ironwood Pharmaceuticals, Inc.:
Media Relations: Trista Morrison
617-374-5095
Tmorrison@ironwoodpharma.com
Investor Relations: Mary T. Conway
617-768-2628
Maconway@ironwoodpharma.com
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SOURCE Allergan plc; Ironwood Pharmaceuticals