New analyses results reinforce effectiveness
and safety for the use of TRULANCE in adults with CIC or IBS-C
Synergy Pharmaceuticals Inc. (NASDAQ: SGYP), a biopharmaceutical
company focused on the development and commercialization of novel
gastrointestinal (GI) therapies, today announced that the company
will present new analyses that further reinforce the efficacy and
safety of TRULANCE® (plecanatide) for adult patients with chronic
idiopathic constipation (CIC) or irritable bowel syndrome with
constipation (IBS-C), specifically in patients aged 65 and older
and in patients using concomitant acid suppression medications such
as proton pump inhibitors (PPIs) and/or histamine receptor
antagonists (H2 blockers). These findings will be presented via two
poster presentations this week at the American College of
Gastroenterology (ACG) Annual Scientific Meeting in
Philadelphia.
Synergy will first present outcomes from a post-hoc analysis of
four Phase 3 trials in CIC and IBS-C patients showing the safety
and tolerability of TRULANCE in adults ≥65, a group in which
constipation is prevalent and there are limited data. The analysis
showed that the safety profile and tolerability of TRULANCE was
similar in patients 65 years and older (mean age 72 years) compared
to those in the younger cohort less than 65 years (mean age 42
years). TRULANCE also showed similar efficacy between the two age
groups (stool consistency, weekly frequency of complete spontaneous
bowel movements (CSBMs), and CSBMs within 24 hours of initiating
therapy).
Adverse events rates were evaluated between those patients aged
65 years and older (TRULANCE: n=151; placebo n=166) and those
younger than 65 years (TRULANCE: n=1,473; placebo n=1,464) to
assess the safety risks in the older population. Results show
similar adverse events and discontinuation rates for patients aged
65 years and older compared to those younger than 65 years, with
the most common adverse event being diarrhea (patients ≥65 years:
4.5% compared to 1.8% for placebo; patients <65 years: 4.4%
compared to 1.1% for placebo).
“There is a minimal amount of available data supporting the
safety and tolerability of treatments for CIC patients among the 65
and over population,” said Stacy B. Menees, M.D., M.S., University
of Michigan, Ann Arbor, MI. “This examination of the data within
this patient population reinforces plecanatide as a valuable
clinical tool to manage CIC and IBS-C in patients aged 65 years and
older.”
Additionally, Synergy will present results from a post-hoc
analysis of two 12-week, double-blind, placebo-controlled trials
which studied the safety and efficacy of TRULANCE in the treatment
of CIC in those patients receiving concomitant acid suppression
therapy. Across the two studies, a total of 883 patients received
TRULANCE compared to 892 receiving placebo. Of these, approximately
10 percent were also receiving concomitant treatment with acid
suppression therapy. The post-hoc analysis explored the impact of
these concomitant therapies on efficacy and safety parameters.
Efficacy and safety results in this subpopulation of patients were
similar to that seen in the overall population.
“Many patients who suffer from constipation are also often on
acid suppressing medications. Because TRULANCE is designed to
replicate the pH-sensitive activity of human uroguanylin, it was
important to understand its efficacy when used along with
medications that raise pH level in the gastrointestinal tract,”
said Baharak Moshiree, M.D., FACG, Professor of Medicine,
University of North Carolina, Atrium Health, Charlotte, NC. “I am
pleased these findings further support the efficacy and safety of
TRULANCE when used concomitantly with acid suppressing agents.”
“A significant proportion of the CIC and IBS-C patient
population have complex medical needs, based on age and
comorbidities,” said Patrick H. Griffin, M.D., Chief Medical
Officer at Synergy Pharmaceuticals Inc. “We are excited to provide
healthcare professionals with new evidence to further reinforce
TRULANCE as an efficacious treatment option with a strong safety
profile for patients aged 65 years and older, as well as for
patients who require concomitant acid suppression therapy.”
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.
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).
About Chronic Idiopathic Constipation (CIC)
CIC affects approximately 14 percent of the global population,
disproportionately affecting women and older adults. People with
CIC have persistent symptoms of difficult-to-pass and infrequent
bowel movements. 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.
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.
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.
About Synergy Pharmaceuticals
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. 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 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/20181008005122/en/
Synergy PharmaceuticalsGem Hopkins, 212-584-7610VP,
Investor Relations and Corporate
Communicationsghopkins@synergypharma.com
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