Synergy Pharmaceuticals to Present New Analyses of TRULANCE® (Plecanatide) at the American College of Gastroenterology (ACG)...
01 Ottobre 2018 - 3:30PM
Business Wire
New analyses further reinforce effectiveness
and safety in important subpopulations of 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 two posters
will be presented at the American College of Gastroenterology (ACG)
Annual Scientific Meeting, October 5-10, 2018, in Philadelphia,
PA.
Presentations include a poster detailing outcomes from a large
post-hoc analysis evaluating the safety and tolerability of
TRULANCE® (plecanatide) in chronic idiopathic constipation (CIC)
and irritable bowel syndrome with constipation (IBS-C) in patients
aged 65 and older compared to those in a younger cohort (≥18 to
<65).
Synergy will also present data from a post-hoc analysis which
evaluated the efficacy and safety of TRULANCE therapy when given in
combination with acid suppression medications.
The findings will be presented via poster presentations as
follows:
Evaluation of the Safety and Tolerability of Plecanatide in
CIC and IBS-C Patients Aged 65 and Older (P0335), to be
presented on Sunday, October 7, 2018 from 5:15 p.m. – 6:30 p.m. ET,
by Stacy B. Menees, M.D., M.S., University of Michigan, Ann Arbor,
MI
Acid Suppression Therapy Does Not Affect the Efficacy of
Plecanatide: A Patient-Level Pooled Analysis of Two Large
Randomized Controlled Trials (P1222), to be presented on
Monday, October 8, 2018, 1:00 p.m. – 2:15 p.m. ET, by Baharak
Moshiree, M.D., FACG, Professor of Medicine, University of North
Carolina, Atrium Health, Charlotte, NC
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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Synergy PharmaceuticalsGem HopkinsVP, Investor Relations and
Corporate Communications212-584-7610ghopkins@synergypharma.com
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