Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) announced today that
the U.S. Food and Drug Administration (FDA) has accepted for filing
the company’s supplemental New Drug Application (sNDA) for
TRULANCE™ (plecanatide) for the treatment of adults with irritable
bowel syndrome with constipation (IBS-C). The Prescription Drug
User Fee Act (PDUFA) date is January 24, 2018.
TRULANCE is a once-daily tablet approved by the FDA for the
treatment of adults with chronic idiopathic constipation (CIC) and
is currently being evaluated for the treatment of adults with
IBS-C. The recommended dosage of TRULANCE for CIC is 3 mg taken
orally, once daily, with or without food at any time of the
day.
“This acceptance by the FDA is an important step forward for
Synergy, building on the recent FDA approval and launch of TRULANCE
for adults with CIC, and signaling the next step in our efforts to
bring TRULANCE to the many millions of people living with IBS-C,”
said Gary S. Jacob, Ph.D., Chairman and CEO, Synergy
Pharmaceuticals Inc. “This milestone is a testament to our entire
team’s passion to the continued research and development of
TRULANCE, which, if approved, represents an additional, much needed
new treatment option for this complex disorder.”
The application is based on data from two randomized, 12-week,
double-blind, placebo-controlled Phase 3 studies evaluating the
efficacy and safety of TRULANCE for the treatment of adults with
IBS-C. Across the two trials, more than 2,100 patients received a
once-daily tablet of TRULANCE (3 mg or 6 mg doses) or placebo.
In these studies, TRULANCE 3 mg and 6 mg doses met the primary
endpoint showing statistical significance in the percentage of
patients who were Overall Responders compared to placebo during the
12-week treatment period (Study 1: 30.2% in 3 mg and 29.5% in
6 mg dose groups compared to 17.8% in placebo; p<0.001 for
3 mg and p<0.001 for 6 mg; Study 2: 21.5% in 3 mg
and 24.0% in 6 mg dose groups compared to 14.2% in placebo;
p=0.009 for 3 mg and p<0.001 for 6 mg).
An Overall Responder, as defined by the U.S. Food and Drug
Administration (FDA), is a patient who fulfills both ≥ 30%
reduction in worst abdominal pain and an increase of ≥ 1 complete
spontaneous bowel movement (CSBM) over baseline, in the same week,
for at least 50% of the 12 treatment weeks. This is the current
primary endpoint required for FDA approval in IBS-C.
In both studies, the most common adverse event was diarrhea
(Study 1 = 3.2% at 3 mg and 3.7% at 6 mg compared to 1.3% at
placebo; Study 2 = 5.4% at 3 mg and 4.3% at 6 mg compared to 0.6%
at placebo).
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
PATIENTS
Trulance™ 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% and greater than in the placebo group) was
diarrhea (5% vs 1% placebo).
Please click here for Full
Prescribing Information.
About Irritable Bowel Syndrome with Constipation
(IBS-C)
Irritable bowel syndrome (IBS) is a chronic gastrointestinal
disorder characterized by recurrent abdominal pain and associated
with two or more of the following: related to defecation,
associated with a change in the frequency of stool, or associated
with a change in the form (appearance) of the stool. IBS can be
subtyped by the predominant stool form: constipation (IBS-C),
diarrhea (IBS-D) or mixed (IBS-M). Those within the IBS-C subtype
experience hard or lumpy stools more than 25 percent of the time
they defecate, and loose or watery stools less than 25 percent of
the time. It is estimated that the prevalence of IBS-C in the U.S.
adult population is approximately 4 to 5 percent, although this
number can vary as patients may fluctuate between the three
subtypes of IBS.
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 substitution for greater binding
affinity, TRULANCE is structurally identical to uroguanylin, a
naturally occurring and endogenous human GI peptide. Uroguanylin
activates GC-C receptors in a pH-sensitive manner primarily in the
small intestine, stimulating fluid secretion and maintaining stool
consistency necessary for regular bowel function.
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 analogs of uroguanylin, a naturally occurring and endogenous
human GI peptide, for the treatment of GI diseases and disorders.
Synergy’s proprietary GI platform includes one commercial product
TRULANCE and a second lead product candidate, 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, 2016. 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. PP-TRU-US-0365
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version on businesswire.com: http://www.businesswire.com/news/home/20170607005714/en/
Synergy PharmaceuticalsGem Hopkins, 212-584-7610VP,
Investor Relations and Corporate
Communicationsghopkins@synergypharma.com
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