Ardelyx Presents Additional Data at the 2024 Digestive Disease Week Conference on IBSRELA® (tenapanor), a First-In-Class Treatment for IBS-C in Adults
21 Maggio 2024 - 2:02PM
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 data supporting additional positive clinical
observations of IBSRELA® (tenapanor) was presented at the 2024
Digestive Disease Week Conference (DDW), currently taking place in
Washington, D.C. IBSRELA is a first-in-class treatment that is
approved by the U.S. Food and Drug Administration to treat
irritable bowel syndrome with constipation (IBS-C) in adults.
“We are thrilled to share new data on the safety and efficacy of
IBSRELA in adults with IBS-C at this year’s DDW Conference as we
seek to continually elucidate its potential benefit in this patient
population. These data provide additional information for both
patients and prescribers as they consider IBSRELA as a potential
new treatment option when symptoms of IBS-C persist despite current
therapies,” said Laura Williams, MD MPH, chief medical officer of
Ardelyx. “These analyses provide further evidence of the role
IBSRELA could play, with its novel mechanism of action, in the
treatment of IBS-C.”
Poster # Tu1658, entitled
“Efficacy of Tenapanor in Patients with Irritable
Bowel Syndrome with Constipation (IBS-C): A Post Hoc Analysis of
Patients with and Without Prior Use of Other IBS-C Prescription
Medications from The Phase 3 T3MPO-1 and T3MPO-2
Studies,” reported results from a post
hoc analysis of the T3MPO-1 and T3MPO-2 studies of tenapanor in
adult patients with IBS-C to examine if there was a difference in
efficacy between patients who had prior use of other IBS-C
prescription medications and those without. A clinically meaningful
response to tenapanor – defined as a complete spontaneous bowel
movement response and an abdominal pain response in the same week
for ≥6 of the first 12 treatment weeks – was observed among adults
with IBS-C regardless of prior IBS-C prescription medication
use.
Poster # Tu1663, entitled
“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 Studies,” reported results from a
pooled analysis of the T3MPO-1 andT3MPO-2 studies of tenapanor in
adult patients with IBS-C to examine the relationship between the
efficacy of tenapanor and patients of Hispanic ethnicity. Per the
analysis, efficacy of tenapanor was comparable, or more pronounced,
in Hispanic patients than in non-Hispanic patients.
Poster presentations are now publicly available and can be
accessed on demand here.
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). 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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