WALTHAM, Mass., May 17, 2022 /PRNewswire/ -- 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 the efficacy and safety
of IBSRELA will be presented in three posters at the 2022 Digestive
Disease Week Conference (DDW 2022) to be held May 21-24, 2022, in San
Diego, California and virtually.
Ardelyx Poster Presentations:
Title:
|
Long Term Treatment
with Tenapanor Improves Abdominal Pain and Other
Abdominal Symptoms Associated with
IBS-C
|
Abstract
Number:
|
3693115
|
Poster
Number:
|
Mo1396
|
Date/Time:
|
May 23, 2022, from
12:30 PM to 1:30 PM PDT
|
|
|
Title:
|
Effect of Tenapanor
on Treatment Satisfaction, Degree of Relief, and Quality of Life
for Patients with Irritable Bowel Syndrome with Constipation
(IBS-C)
|
Abstract
Number:
|
3693709
|
Poster
Number:
|
Mo1394
|
Date/Time:
|
May 23, 2022, from
12:30 PM to 1:30 PM PDT
|
|
|
Title:
|
Tenapanor has Early
Onset of Action in Treating Symptoms of Irritable Bowel Syndrome
with Constipation (IBS-C) (T3MPO-1 and T3MPO-2
Trials)
|
Abstract
Number:
|
3693673
|
Poster
Number:
|
Tu1375
|
Date/Time:
|
May 24, 2022, from
12:30 PM to 1:30 PM PDT
|
In addition to the poster presentations during DDW, Ardelyx is
sponsoring a Product Theater titled: IBSRELA, an Innovative
Approach for the Treatment of Irritable Bowel Syndrome with
Constipation (IBS-C) in Adults, on May
23, 2022, from 2:30-3:15pm PT,
where thought leading experts Dr. Brooks
Cash and Dr. Mark Pimentel,
will review the multifactorial pathophysiology of IBS-C, the novel
mechanism of action of IBSRELA, and efficacy and safety data of
IBSRELA from the Phase 3 clinical trial program.
Product Theater speakers: Brooks D.
Cash, MD, FACG, AGAF, FASGE, Dan and Lillie Sterling
Professor of Medicine, Chief, Gastroenterology, Hepatology,
and Nutrition, UT Health Science Center at Houston McGovern
Medical School, and Mark Pimental,
MD, FRCP(C), Executive Director, Medically Associated Science and
Technology (MAST) Program, Cedars- Sinai Medical Center, Los
Angeles, CA.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC
PATIENTS
IBSRELA 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.
|
CONTRAINDICATIONS
- IBSRELA is contraindicated in patients less than 6 years of age
due to the risk of serious dehydration.
- IBSRELA is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction.
WARNINGS AND PRECAUTIONS
Risk 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 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 11 million people in
the US. IBS-C is associated with significantly impaired quality of
life, reduced productivity, and substantial economic burden.
About IBSRELA for IBS-C
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 Ardelyx, Inc.
Ardelyx was founded with a mission to discover, develop and
commercialize innovative first-in-class medicines that meet
significant unmet medical needs. Ardelyx's first approved product,
IBSRELA® (tenapanor) is available in the United States. Ardelyx is developing
XPHOZAH® (tenapanor), a novel product candidate to
control serum phosphorus in adult patients with CKD on dialysis,
which has completed three successful Phase 3 trials. Ardelyx has a
Phase 2 potassium secretagogue program, RDX013, for the potential
treatment of elevated serum potassium, or hyperkalemia, a problem
among certain patients with kidney and/or heart disease and an
early-stage program in metabolic acidosis, a serious electrolyte
disorder in patients with CKD. Ardelyx has established agreements
with Kyowa Kirin in Japan, Fosun
Pharma in China and Knight
Therapeutics in Canada for the
development and commercialization of tenapanor in their respective
territories.
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SOURCE Ardelyx