Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) announced today that
the U.S. Food and Drug Administration (FDA) has approved
TRULANCE™ (plecanatide) for the treatment of adults with
chronic idiopathic constipation (CIC). TRULANCE is the first drug
designed to replicate the function of uroguanylin, a naturally
occurring and endogenous human gastrointestinal (GI) peptide that
is thought to stimulate fluid secretion which results in a stool
consistency associated with more regular bowel function.
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“We are thrilled with the approval of TRULANCE because it
provides an additional, much-needed, new treatment option to help
adults with chronic idiopathic constipation and their healthcare
providers manage this condition,” said Gary S. Jacob, Ph.D.,
Chairman and CEO of Synergy Pharmaceuticals Inc. “I am confident
that we truly have the right team with the right strategic vision
and the right launch plan to successfully bring TRULANCE into this
large but underserved market.”
CIC is a complex, functional GI disorder defined by symptoms
including fewer than three bowel movements a week and hard-to-pass
or incomplete bowel movements, for which there is no identifiable
cause.1,2 CIC affects approximately 33 million Americans and an
estimated 14 percent of the global population.2
The efficacy and safety of TRULANCE was evaluated in the largest
Phase 3 CIC clinical trials to date, which included more than 2,600
patients in two randomized, 12-week, double-blind,
placebo-controlled studies of TRULANCE.
Over 12 weeks, patients treated with TRULANCE achieved a
significantly greater efficacy responder rate — the primary
endpoint defined by the FDA for regulatory approval in CIC — in
both studies compared to placebo (Study 1: 21% vs. 10%; Study 2:
21% vs. 13%, p<0.005 for both studies). Efficacy responders were
defined as patients who had at least three complete spontaneous
bowel movements (CSBMs) in a given week and an increase of at least
one CSBM over baseline in the same week for at least nine weeks out
of the 12-week period, including at least three of the last four
weeks.
Over 12 weeks, patients who received TRULANCE in both studies
also had improvements as compared to placebo in stool frequency (as
measured by the number of spontaneous bowel movements per week),
stool consistency (as measured by the Bristol Stool Form Scale) and
straining with bowel movements.
"The impact of chronic constipation on the lives of affected
patients is often underestimated,” said William D. Chey, M.D.,
Professor of Medicine, Director of the GI Physiology Laboratory,
and Co-Director of the Michigan Bowel Control Program at the
University of Michigan. “TRULANCE presents an exciting new
treatment option for patients with chronic constipation. Its
efficacy and safety profile, plus its negligible systemic
absorption, are attractive attributes that make it a welcome
addition to our treatment options.”
In an integrated analysis of both studies, diarrhea was the most
common adverse reaction, reported in 5% of patients treated with
TRULANCE compared to 1% of patients treated with placebo. Overall
discontinuation rates were low among patients treated with TRULANCE
and placebo (4% vs. 2%, respectively) and the most common adverse
reaction leading to discontinuation was diarrhea (2% for TRULANCE
compared to 0.5% in placebo).
The approved dosing regimen for TRULANCE is 3 mg taken orally,
once daily, with or without food at any time of the day. TRULANCE
can be swallowed whole or crushed in applesauce for those who are
unable to swallow medication.
TRULANCE will be available in the U.S. later this quarter.
Synergy has also completed two Phase 3 clinical trials for
TRULANCE in irritable bowel syndrome with constipation (IBS-C) and
plans to file a New Drug Application Supplement with Clinical Data
(sNDA) later this quarter with an expected 10-month review period
from submission.
Indications and Usage
TRULANCE is a guanylate cyclase-C (GC-C) agonist indicated in
adults for the treatment of chronic idiopathic constipation
(CIC).
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC
PATIENTSTrulance™ is contraindicated in patients less than 6
years of age; in nonclinical studies in young juvenile mice
administration of a single oral dose of plecanatide caused deaths
due to dehydration. Use of Trulance should be avoided in patients 6
years to less than 18 years of age. The safety and efficacy of
Trulance have not been established in pediatric patients less than
18 years of age.
Contraindications
- Trulance is contraindicated in patients
less than 6 years of age due to the risk of serious
dehydration.
- Trulance is contraindicated in patients
with known or suspected mechanical gastrointestinal
obstruction.
Warnings and Precautions
Risk of Serious Dehydration in Pediatric Patients
- Trulance is contraindicated in patients
less than 6 years of age. The safety and effectiveness of Trulance
in patients less than 18 years of age have not been established. In
young juvenile mice (human age equivalent of approximately 1 month
to less than 2 years), plecanatide increased fluid secretion as a
consequence of stimulation of guanylate cyclase-C (GC-C), resulting
in mortality in some mice within the first 24 hours, apparently due
to dehydration. Due to increased intestinal expression of GC-C,
patients less than 6 years of age may be more likely than older
patients to develop severe diarrhea and its potentially serious
consequences.
- Use of Trulance should be avoided in
patients 6 years to less than 18 years of age. Although there were
no deaths in older juvenile mice, given the deaths in young mice
and the lack of clinical safety and efficacy data in pediatric
patients, use of Trulance should be avoided in patients 6 years to
less than 18 years of age.
Diarrhea
- Diarrhea was the most common adverse
reaction in the two placebo-controlled clinical trials. Severe
diarrhea was reported in 0.6% of patients.
- If severe diarrhea occurs, the health
care provider should suspend dosing and rehydrate the patient.
Adverse Reactions
- In the two combined CIC clinical
trials, the most common adverse reaction in Trulance-treated
patients (incidence ≥2% than in the placebo group) was diarrhea (5%
vs 1% placebo).
Please click here for Full Prescribing
Information.
About Chronic Idiopathic Constipation (CIC)
CIC affects approximately 14 percent of the global population,
disproportionately affecting women and older adults.2 People with
CIC have persistent symptoms of difficult and infrequent bowel
movements.1 In addition to physical symptoms including abdominal
bloating and discomfort, CIC can adversely affect an individual’s
quality of life, including increasing stress levels and
anxiety.1
About TRULANCE™
TRULANCE™ (plecanatide) is a once-daily tablet approved for
adults with CIC and is being evaluated for IBS-C. With the
exception of a single amino acid, TRULANCE is structurally related
to uroguanylin, a naturally occurring and endogenous human GI
peptide. Uroguanylin is thought to act in a pH-sensitive manner,
targeting GC-C receptors primarily in the small intestine
coinciding with areas of fluid secretion.
About Synergy Pharmaceuticals
Synergy is a biopharmaceutical company focused on the
development and commercialization of novel GI therapies. The
company has pioneered discovery, research and development efforts
on uroguanylin analogs for the treatment of functional GI disorders
and inflammatory bowel disease. Synergy’s proprietary uroguanylin
analog platform includes two lead product candidates – plecanatide
and dolcanatide. For more information, please
visit www.synergypharma.com.
Forward-Looking Statement
This press release and any statements made for and during any
presentation or meeting contain forward-looking statements related
to Synergy Pharmaceuticals Inc. under the safe harbor provisions of
Section 21E of the Private Securities Litigation Reform Act of 1995
and are subject to risks and uncertainties that could cause actual
results to differ materially from those projected. These statements
may be identified by the use of forward-looking words such as
"anticipate," "planned," "believe," "forecast," "estimated,"
"expected," and "intend," among others. There are a number of
factors that could cause actual events to differ materially from
those indicated by such forward-looking statements. These factors
include, but are not limited to, the development, launch,
introduction and commercial potential of TRULANCE; growth and
opportunity, including peak sales and the potential demand for
TRULANCE, as well as its potential impact on applicable markets;
market size; substantial competition; our ability to continue as a
going concern; our need for additional financing; uncertainties of
patent protection and litigation; uncertainties of government or
third party payer reimbursement; dependence upon third parties; our
financial performance and results, including the risk that we are
unable to manage our operating expenses or cash use for operations,
or are unable to commercialize our products, within the guided
ranges or otherwise as expected; and risks related to failure to
obtain FDA clearances or approvals and noncompliance with FDA
regulations. As with any pharmaceutical under development, there
are significant risks in the development, regulatory approval and
commercialization of new products. There are no guarantees that
future clinical trials discussed in this press release will be
completed or successful or that any product will receive regulatory
approval for any indication or prove to be commercially successful.
Investors should read the risk factors set forth in Synergy's most
recent periodic reports filed with the Securities and Exchange
Commission, including Synergy’s Form 10-K for the year ended
December 31, 2015. While the list of factors presented here is
considered representative, no such list should be considered to be
a complete statement of all potential risks and uncertainties.
Unlisted factors may present significant additional obstacles to
the realization of forward-looking statements. Forward-looking
statements included herein are made as of the date hereof, and
Synergy does not undertake any obligation to update publicly such
statements to reflect subsequent events or circumstances except as
required by law.
1 Thomas R, Luthin D. Current and emerging treatments for
irritable bowel syndrome with constipation and chronic idiopathic
constipation: focus on prosecretory agents. Pharmacotherapy Pub.
2015; 613-630.2 Suares NC, Ford AC. Prevalence of, and risk factors
for chronic idiopathic constipation in the community: systematic
review and meta-analysis. Am J Gastroenterol.
2011;106(9):1582-1591.
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version on businesswire.com: http://www.businesswire.com/news/home/20170119006330/en/
Company:Synergy PharmaceuticalsGem Hopkins,
212-584-7610VP, Investor Relations and Corporate
Communicationsghopkins@synergypharma.com
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