Ardelyx Presents Additional Data Detailing Educational Needs Related to IBS-C Management Across Healthcare Disciplines
June 28 2024 - 8:17AM
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 detailing educational needs related to
irritable bowel syndrome with constipation (IBS-C) across
healthcare disciplines was presented via a poster at the 2024
American Association of Nurse Practitioners (AANP) Annual
Conference, currently taking place in Nashville, Tennessee.
Poster IND #37, entitled “Educational
Needs Related to Irritable Bowel Syndrome with Constipation (IBS-C)
Management Across Disciplines: a Comparison of Nurse Practitioners,
Physician Assistants, and Physicians” includes findings
from a case-based survey involving 410 cross-disciplinary
healthcare professionals (HCPs) and sheds light on practice
differences and educational requirements related to the diagnosis
and management of IBS-C. The data reveals notable differences
between nurse practitioners (NPs)/physician assistants (PAs) and
physicians, particularly in their choice of IBS-C diagnostic
criteria and testing methodologies, tendency to refer patients to
specialists and approach to assessing pain levels. It also shows
that gastroenterology HCPs are more likely to prescribe
linaclotide, plecanatide or tenapanor for IBS-C patients who avoid
social events due to discomfort, whereas primary care physicians
are more likely to prescribe neuromodulators. These findings show
the importance of tailoring educational initiatives to meet the
specific needs of different clinical specialties and roles within
the healthcare landscape.
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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