Ardelyx Announces US Launch of IBSRELA®, a New First-in-Class Treatment for IBS-C in Adults
- IBSRELA®(tenapanor) is the First and Only NHE3 Inhibitor FDA Approved for the Treatment of IBS-C in Adults
- First Novel Mechanism Therapy to Treat IBS-C in a Decade
- Product Now Available
"The commercialization of IBSRELA marks a significant milestone for
The approval of IBSRELA is based on two successful Phase 3 trials involving over 1,200 patients with IBS-C. Both trials met their primary endpoint – significantly more patients treated with IBSRELA vs. placebo were overall responders (experienced a ≥30% improvement in abdominal pain from baseline and an increase in at least one complete spontaneous bowel movement per week from baseline, in the same week for at least 6 of the first 12 weeks of treatment). In T3MP0-2, the Phase 3 long-term trial, improvements from baseline in average weekly bowel movements, abdominal pain, bloating and other abominal symptoms were observed as early as Week 1, with improvement sustained through the end of the 26-week trial. Additionally in the Phase 3 trial T3MP0-2, patients treated with IBSRELA reported a 41% improvement in quality of life score from baseline to end of treatment, and the vast majority of patients reported satisfaction with treatment. The most common side effect in clincial trials was diarrhea, occurring in 16% of patients (4% placebo), and was most commonly mild-to-moderate and transient, resolving in ≤1 week with continued treatment.
As a company dedicated to advancing patient care,
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.
- 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.
- 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 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.
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%).
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.
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.
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.
To the extent that statements contained in this press release are not descriptions of historical facts regarding
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