Market Overview

Synergy Pharmaceuticals Announces TRULANCE® (plecanatide) Added to Express Scripts 2019 National Preferred Formulary List


Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced that leading
U.S. pharmacy benefit manager, Express Scripts, will add TRULANCE to its
National Preferred Formulary List, effective January 1, 2019.

This follows the FDA approval of the second indication for TRULANCE for
the treatment of adults with irritable bowel syndrome with constipation
(IBS-C) in January 2018. TRULANCE was first approved by the FDA for the
treatment of adults with chronic idiopathic constipation (CIC) in
January 2017. TRULANCE is the only prescription medication for adults
with CIC and IBS-C that can be taken once-daily, with or without food,
at any time of the day.

"We are pleased that TRULANCE will be added to Express Scripts National
Preferred Formulary List. This decision strengthens our belief that
TRULANCE provides an effective treatment option for patients living with
chronic GI conditions." said Troy Hamilton, Chief Executive Officer of
Synergy Pharmaceuticals Inc. "This is a significant step in our ongoing
efforts to expand patient access to TRULANCE and we expect this critical
coverage win and others we anticipate achieving to drive continued
growth for many years to come."


TRULANCE® (plecanatide) is a once-daily tablet approved for
adults with CIC or 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.

Indications and Usage

TRULANCE (plecanatide) 3 mg tablets is indicated in adults for the
treatment of Chronic Idiopathic Constipation (CIC) and Irritable Bowel
Syndrome with Constipation (IBS-C).



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.


  • 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 was the most common adverse reaction in the four
    placebo-controlled clinical trials for CIC and IBS-C. Severe diarrhea
    was reported in 0.6% of TRULANCE-treated CIC patients, and in 1% of
    TRULANCE-treated IBS-C 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).
  • In the two combined IBS-C clinical trials, the most common adverse
    reaction in TRULANCE-treated patients (incidence ≥2% and greater than
    in the placebo group) was diarrhea (4.3% vs 1% placebo).

Please also see the full
Prescribing Information
, including Box Warning, for additional
risk information.

About Synergy Pharmaceuticals Inc.

Synergy is a biopharmaceutical company focused on the development and
commercialization of novel gastrointestinal (GI) therapies. The company
has pioneered discovery, research and development efforts around analogs
of uroguanylin, a naturally occurring human GI peptide, for the
treatment of GI diseases and disorders. Synergy's proprietary GI
platform includes one commercial product TRULANCE® (plecanatide) and a
second product candidate – dolcanatide. For more information, please

Forward-Looking Statement

Certain statements in this press release are forward-looking within the
meaning of the Private Securities Litigation Reform Act of 1995. These
statements may be identified by the use of forward-looking words such as
"anticipate," "planned," "believe," "forecast," "estimated," "expected,"
and "intend," among others. These forward-looking statements are based
on Synergy's current expectations and actual results could differ
materially. 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, 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; limited
sales and marketing efforts and dependence upon third parties; and risks
related to failure to obtain FDA clearances or approvals and
noncompliance with FDA regulations. Investors should read the risk
factors set forth in Synergy's Annual Report on Form 10-K for the year
ended December 31, 2017 and other periodic reports filed with the
Securities and Exchange Commission. 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.

View Comments and Join the Discussion!