Synergy Pharmaceuticals Announces TRULANCE® (plecanatide) Added to Express Scripts 2019 National Preferred Formulary List
07 Agosto 2018 - 3:00PM
Business Wire
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.”
About TRULANCE®
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).
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 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
visit www.synergypharma.com.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20180807005483/en/
Synergy Pharmaceuticals Inc.Gem Hopkins, 212-584-7610VP,
Investor Relations and Corporate
Communicationsghopkins@synergypharma.com
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