WALTHAM, Mass., Oct. 24, 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 post-hoc analyses from its Phase 3 T3MPO trials will be presented in two posters at the 2022 American College of Gastroenterology Annual Scientific Meeting (ACG 2022) taking place in Charlotte, North Carolina from October 21-26, 2022 and virtually.
"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 Laura Williams, chief medical officer of Ardelyx. "In adult patients with IBS-C, IBSRELA was found to improve abdominal symptom scores, which included symptoms such as abdominal pain, discomfort, bloating, fullness and cramping, over the 26-week treatment period. Additionally, IBSRELA treatment significantly improved the complete spontaneous bowel movement durable response. These data add to the potential impact IBSRELA can have for people living with IBS-C."
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, from 3:00pm-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, from 3:00pm-5:00pm EDT
In addition to the poster presentations during ACG, Ardelyx is sponsoring a Product Theater titled: An Innovative Approach to the Treatment of Adults with Irritable Bowel Syndrome with Constipation (IBS-C), on Monday, October 24, 2022, from 2:45pm-3:15pm ET. During this Product Theater, Dr. Susan Lucak, MD, will review the multifactorial pathophysiology of IBS-C, the novel mechanism of action of IBSRELA, and safety and efficacy data for IBSRELA from the Phase 3 clinical development program.
Product Theater speaker: Susan L. Lucak, MD, affiliated assistant professor of clinical medicine, Weill Cornell Medicine; special lecturer, Columbia University Medical Center; attending physician, Lenox Hill Hospital New York, NY.
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