Ardelyx to Present Poster Presentations on IBSRELA® (tenapanor) for Adult Patients with IBS-C at the American College of Gastroenterology 2022 Annual Scientific Meeting
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:
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
WARNINGS AND PRECAUTIONS
Risk of Serious Dehydration in Pediatric Patients
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%).
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
About Ardelyx, Inc.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including the potential for IBSRELA to treat patients with CIC. Such forward-looking statements involve substantial risks and uncertainties that could cause Ardelyx's future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties associated with the drug development process and the regulatory approval process. Ardelyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ardelyx's business in general, please refer to Ardelyx's Quarterly Report on Form 10-K filed with the Securities and Exchange Commission on August 4, 2022, and its future current and periodic reports to be filed with the Securities and Exchange Commission.
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Company Codes: NASDAQ-NMS:ARDX