Ardelyx to Present Poster Presentations on IBSRELA® (tenapanor) for Adult Patients with IBS-C at the American College of Gastroenterology 2022 Annual Scientific Meeting
"The Phase 3 studies we conducted in support of IBSRELA's approval are robust and provide extensive data, and at ACG, we are presenting new post-hoc analyses that elucidate additional benefits observed for patients treated with IBSRELA versus placebo," said
Ardelyx Poster Presentations:
- Poster # C0268, entitled "Efficacy of Tenapanor in Improving IBS-C Abdominal Symptoms: A Post Hoc Analysis of Multi-item Abdominal Score From the 26-Week Phase 3 T3MPO-2 Study," to be presented on
October 24, 2022 , from3:00pm-5:00pm EDT - Poster # E0264, entitled "Potential of Tenapanor as a Treatment for Chronic Idiopathic Constipation: A Post Hoc Analysis from the Phase 3 T3MPO-1 and T3MPO-2 Studies for Irritable Bowel Syndrome with Constipation in Adults," to be presented on
October 25, 2022 , from3:00pm-5:00pm EDT
In addition to the poster presentations during ACG,
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS |
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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
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding
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SOURCE
Investor and Media Contacts: Kimia Keshtbod, kkeshtbod@ardelyx.com, Sylvia Wheeler, Wheelhouse Life Science Advisors, swheeler@wheelhouselsa.com, Alex Santos, Wheelhouse Life Science Advisors, asantos@wheelhouselsa.com