Chronic constipation

Ninety percent of survey participants reported “some” or “significant” negative impact of IBS-C on their life Survey results presented in two poster presentations WALTHAM, Mass., Oct. 28, 2024 (GLOBE NEWSWIRE) -- 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 results from the IBS in America 2024 supplemental survey, in partnership with Health Union, were presented at the American College of Gastroenterology’s (ACG) Annual Scientific Meeting & Postgraduate Course, currently taking place in Philadelphia. Developed as an online, nationwide survey conducted in partnership with Health Union, more than 280 irritable bowel syndrome with constipation (IBS-C) patients were surveyed to better understand their symptoms and the impact of IBS-C on their overall health and quality of life. “Ardelyx is committed to better understanding the lived experience of patients with IBS-C, and the insights gained from our IBS in America supplemental survey clearly outline the everyday impact of IBS-C on patients, which extends far beyond constipation and results in a low quality of life for many patients,” said Johannah Ruddy, M.Ed, director, patient advocacy at Ardelyx. “The supplemental survey provides us with unique insights into what symptoms patients are experiencing, and how often. We hope these findings spark productive conversations between patients and their healthcare providers on how to recognize, understand and treat IBS-C to improve the lives of those living with this condition, and raise awareness of the need for broader dialogue around this condition.” Notably, 90% of IBS-C patients surveyed reported “some” or “significant” negative impact of IBS-C on their life, with a majority indicating they feel a negative impact on their mental and emotional health, sexual health and intimacy, relationships and sense of independence. More than one-third of IBS-C patients described their quality of life as “poor” or “fair,” often attributed to having multiple health conditions. The comorbidities most experienced and reported included mental health conditions, chronic pain conditions, metabolic disorders and other gastrointestinal disorders. A Media Snippet accompanying this announcement is available by clicking on this link. Additional survey findings include: 85% of patients experienced pain in the rectum or anus while trying to have bowel movementsOver 55% of patients reported a feeling of incomplete bowel movement “often” or “always” in the previous seven daysMost of those surveyed experienced other symptoms in addition to constipation, including: 86% of patients experienced bloating85% of patients experienced abdominal cramps and pain64% of patients experienced fatigue Of the 104 respondents currently perimenopausal or having menstrual periods, more than 45% felt that menstruation made constipation worse, and over 80% felt menstruation exacerbated abdominal pain and bloating symptomsOver 45% of patients considered IBS-C “somewhat,” “quite a bit” or “very much” a financial hardship to themselves and their families Data from the IBS in America 2024 supplemental survey was presented in two posters during ACG’s Annual Scientific Meeting this week, which are publicly available here. Title: Irritable Bowel Syndrome With Constipation Poses a Substantial Burden to Patient Overall Health Status and Quality of Life: Results From the IBS In America 2024 Real-World SurveyAuthors: Eric Shah, Johannah Ruddy, Belinda Gist, Elizabeth Stremke, Laura Williams, Baharak MoshireePoster Number: P0641 Title: Patients With Irritable Bowel Syndrome With Constipation From the IBS In America 2024 Real-World Survey Experience Burdensome Symptoms Beyond ConstipationAuthors: Baharak Moshiree, Johannah Ruddy, Belinda Gist, Elizabeth Stremke, Laura Williams, Eric ShahPoster Number: P2335 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. About IBS in America 2024IBS in America 2024 was a 15-minute, real-world, online survey fielded by Health Union from January 15 to April 14, 2024, in United States residents age 18 and older. The survey covered demographics, comorbidities, quality of life impact, treatments and health care provider (HCP) interactions. Patients who completed the survey were invited to participate in an institutional review board–approved supplemental extension survey if they met the following criteria: diagnosed with IBS-C or IBS with alternating diarrhea and constipation by an HCP, currently seeing an HCP to treat IBS, and had ever used an over the counter or prescription treatment for IBS. Four questions addressed patients’ menstrual status and the impact of menstruation on constipation. These analyses only include patients diagnosed with IBS-C who completed the supplemental extension survey. Respondents with IBS-C (N=284) had a mean (range) age of 51 (18-86) years and were predominantly female (92%; 48% postmenopausal) and White (87%). Most respondents had been living with IBS-C for ≥2 years, and 80% of respondents reported IBS episodes occurring weekly or daily over the past year. This survey was designed to learn about patients’ experience with IBS-C and did not investigate safety or efficacy of any prescription drugs for management of IBS-C. About Health UnionHealth Union is the proven industry leader in condition-specific, online health community and patient engagement. The company reaches millions of people through the largest network of online health communities (e.g., Migraine.com, MultipleSclerosis.net, LungCancer.net) and health leaders – addressing virtually every condition and providing patients and caregivers with the information, connection, and support they need to live better with challenging health conditions. For more than a decade, Health Union has been transforming the way pharmaceutical and healthcare brands engage with people, enabling transparent, innovative opportunities to gain insight and empower action through advertising, marketing research, and clinical trial solutions for the healthcare industry. 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

WALTHAM, Mass., Oct. 22, 2024 (GLOBE NEWSWIRE) -- 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 the launch of Gut Matters: Discoveries and Innovations, a new podcast for the irritable bowel syndrome with constipation (IBS-C) patient community. The podcast is hosted by Ardelyx’s director, patient advocacy, Johannah Ruddy, M.Ed. and practicing gastroenterologist, Andrea Shin, MD. The first episode is out now. Each month, the hosts will be joined by patients, caregivers, advocacy leaders, healthcare providers and other gastroenterology experts to discuss the impact of IBS-C and provide education and hope for those affected. “People living with IBS-C often feel lonely and stigmatized. We wanted to create a safe space where people with this condition can find fact-based information, hear stories that likely sound like their own, and gain valuable insights that will provide them with hope as well as the tools to better manage their condition,” said Andrea Shin, MD and podcast co-host. “I am really proud to be a part of the Gut Matters: Discoveries and Innovations podcast. Our hope is to empower patients, family members and caregivers by showing them that they are part of a large community.” Individuals can subscribe to the podcast and keep up on the latest episodes here, or wherever they get their podcasts. 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. 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

WALTHAM, Mass., Oct. 09, 2024 (GLOBE NEWSWIRE) -- 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 the recent publication of a review article, titled “Review of the Patient Burden and Therapeutic Landscape of Irritable Bowel Syndrome With Constipation in the United States” in Clinical and Experimental Gastroenterology, an international, peer reviewed, open access journal focusing on all aspects of gastroenterology research, as well as clinical results in human, animal and in vitro studies that shed light on disease processes and potential new therapies. The article provides an overview of treatment options and disease management for irritable bowel syndrome with constipation (IBS-C) from a U.S. perspective and discusses the importance of the relationship between patient and health care provider in diagnosis and treatment. It recommends a positive diagnostic strategy for IBS-C, based on clinical history, physical examination, and minimal laboratory tests. “IBS-C patients often experience a high level of disease burden across a variety of factors which extend beyond the physical symptoms associated with the condition. Patients often report negative economic, social and mental health impacts due to IBS-C, which makes even daily activities challenging,” said Morgan Allyn Sendzischew Shane, MD, Division of Gastroenterology and Digestive Disease, University of Miami and lead author of the article. “It’s critical that the larger healthcare community understands the full patient experience, especially as we see how important the patient and healthcare provider relationship is in regard to diagnosis and treatment.” The authors review the substantial societal burden in terms of health care costs, opportunity costs and decreased quality of life that comes with IBS-C. The article also reviews the treatment journey a patient with IBS-C may experience, beginning with lifestyle interventions and nonpharmacologic options, with progression to a U.S. FDA-approved therapy. IBSRELA® (tenapanor) is identified as one of the currently approved therapies, with data from the T3MPO-1 and T3MPO-2 studies included within the review. IBSRELA is a first-in-class treatment for IBS-C in adults that is approved by the U.S. Food and Drug Administration. The article is available online and can be accessed here. About IBSRELA® (tenapanor)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. 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 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 dehydrationpatients 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