Ardelyx to Present Additional Data Supporting First-In-Class IBSRELA® (tenapanor) for Adults with Irritable Bowel Syndrome with Constipation at the 2024 Digestive Disease Week Conference
07 Mai 2024 - 2:01PM
Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded
with a mission to discover, develop and commercialize innovative,
first-in-class medicines that meet significant unmet medical needs,
today announced that additional data supporting IBSRELA®
(tenapanor) will be presented at the 2024 Digestive Disease Week
Conference (DDW), to be held May 18-21, 2024, in Washington, D.C.
IBSRELA is approved by the U.S. Food and Drug Administration to
treat irritable bowel syndrome with constipation (IBS-C) in adults.
Title: Efficacy of Tenapanor in Patients with Irritable
Bowel Syndrome With Constipation (IBS-C): A Posthoc Analysis of
Patients With and Without Prior Use of Other IBS-C Prescription
Medications From the Phase 3 T3MPO-1 and T3MPO-2
StudiesAuthors: Eric Shah, Brian Lacy, Yang Yang, Susan
Edelstein, David RosenbaumPoster Number: Tu1658Date/Time: May 21,
2024, from 12:30 PM to 1:30 PM EDT (UTC –4)
Title: Comparing the Efficacy of Tenapanor in Irritable
Bowel Syndrome with Constipation in Hispanic vs Non-Hispanic
Patients: A Posthoc Analysis of Patients in the Phase 3 T3MPO-1 and
T3MPO-2 StudiesAuthors: Rosita Frazier, William Hasler,
Yang Yang, Susan Edelstein, David RosenbaumPoster Number:
Tu1663 Date/Time:
May 21, 2024, from 12:30 PM to 1:30 PM EDT (UTC –4)
In addition to the poster presentations during DDW, Ardelyx is
sponsoring a Product Theater titled:
“Discover IBSRELA: a Different Mechanism
of Action to Treat Adults With IBS-C: A Case-Based
Discussion,” on May 19, 2024, from 2:30-3:15 PM EDT, where
Brooks Cash, MD, will lead an engaging discussion about important
clinical considerations for managing IBS-C in adult patients. The
presentation will include interactive patient case studies, along
with IBSRELA efficacy and safety data from the Phase 3 clinical
trial program.
About IBSRELA® (tenapanor)IBSRELA (tenapanor)
is a locally acting inhibitor of the sodium/hydrogen exchanger 3
(NHE3), an antiporter expressed on the apical surface of the small
intestine and colon primarily responsible for the absorption of
dietary sodium. By inhibiting NHE3 on the apical surface of the
enterocytes, tenapanor reduces absorption of sodium from the small
intestine and colon, thus retaining luminal water content, which
accelerates intestinal transit time and results in a softer stool
consistency. IBSRELA has also been shown to reduce abdominal pain
by decreasing visceral hypersensitivity and by decreasing
intestinal permeability in animal models. In a rat model of colonic
hypersensitivity, tenapanor reduced visceral hyperalgesia and
normalized colonic sensory neuronal excitability.
About Irritable Bowel Syndrome with Constipation
(IBS-C)Irritable bowel syndrome with constipation (IBS-C)
is a gastrointestinal disorder characterized by both abdominal pain
and altered bowel movements, estimated to affect 12 million people
in the U.S. IBS-C is associated with significantly impaired quality
of life, reduced productivity, and substantial economic burden.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC
PATIENTSIBSRELA is contraindicated in patients
less than 6 years of age; in nonclinical studies in young juvenile
rats administration of tenapanor caused deaths presumed to be due
to dehydration. Avoid use of IBSRELA in patients 6 years to less
than 12 years of age. The safety and effectiveness of IBSRELA have
not been established in patients less than 18 years of
age. |
CONTRAINDICATIONSIBSRELA is contraindicated
in:
- patients less than 6 years of age
due to the risk of serious dehydration
- patients with known or suspected
mechanical gastrointestinal obstruction
WARNINGS AND PRECAUTIONSRisk of Serious
Dehydration in Pediatric Patients
- IBSRELA is contraindicated in patients below 6 years of age.
The safety and effectiveness of IBSRELA in patients less than 18
years of age have not been established. In young juvenile rats
(less than 1 week old; approximate human age equivalent of less
than 2 years of age), decreased body weight and deaths occurred,
presumed to be due to dehydration, following oral administration of
tenapanor. There are no data available in older juvenile rats
(human age equivalent 2 years to less than 12 years).
- Avoid the use of IBSRELA in patients 6 years to less than 12
years of age. Although there are no data in older juvenile rats,
given the deaths in younger rats and the lack of clinical safety
and efficacy data in pediatric patients, avoid the use of IBSRELA
in patients 6 years to less than 12 years of age.
Diarrhea Diarrhea was the most common adverse
reaction in two randomized, double-blind, placebo-controlled trials
of IBS-C. Severe diarrhea was reported in 2.5% of IBSRELA-treated
patients. If severe diarrhea occurs, suspend dosing and rehydrate
patient.
MOST COMMON ADVERSE REACTIONS The most common
adverse reactions in IBSRELA-treated patients (incidence ≥2% and
greater than placebo) were: diarrhea (16% vs 4% placebo), abdominal
distension (3% vs <1%), flatulence (3% vs 1%) and dizziness (2%
vs <1%).
INDICATION IBSRELA (tenapanor) is indicated for
the treatment of Irritable Bowel Syndrome with Constipation (IBS-C)
in adults. Please see full Prescribing Information, including Boxed
Warning, for additional risk information.
About ArdelyxArdelyx was founded with a mission
to discover, develop and commercialize innovative, first-in-class
medicines that meet significant unmet medical needs. Ardelyx has
two commercial products approved in the United States, IBSRELA®
(tenapanor) and XPHOZAH® (tenapanor) as well as early-stage
pipeline candidates. Ardelyx has agreements for the development and
commercialization of tenapanor outside of the U.S. Kyowa Kirin
commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in
Japan. A New Drug Application for tenapanor for hyperphosphatemia
has been submitted in China with Fosun Pharma. Knight Therapeutics
commercializes IBSRELA in Canada. For more information, please
visit https://ardelyx.com/ and connect with us on X (formerly known
as Twitter), LinkedIn and Facebook.
Investor and Media Contacts: Caitlin
Lowieclowie@ardelyx.com
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