Ardelyx Medical Affairs
Our scientific and clinical experts provide timely, accurate, and balanced information about Ardelyx products and disease states of interest.
Our mission is to be the scientific partner of choice for the medical community in the therapeutic areas that we serve.
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An Adverse Event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Call your doctor for medical advice about side effects.
To report a known or suspected adverse event, please call 1.844.427.7352 or email MedInfo@ardelyx.com, or Click Here. You may also report adverse events to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
You may report Product Complaints at 1.844.427.7352 or email MedInfo@ardelyx.com, or Click Here.
A Product Complaint (PC) is any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a drug or device after it is released for distribution.
To submit an inquiry or to contact Medical Information, Click Here.
What is CKD?
Chronic kidney disease (CKD) is the progressive deterioration of kidney function that can occur over time. The kidneys’ main job is to filter excess water and waste out of blood via urine. To keep the body working properly, the kidneys balance salts and minerals—such as calcium, phosphorus, sodium, and potassium—that circulate in the blood. Kidneys also make hormones that help control blood pressure, make red blood cells, and keep bones strong.
If deterioration of the kidneys continues, the disease will likely cause significant cardiovascular morbidity, and can progress to kidney failure.
Current management of kidney failure includes hemodialysis and peritoneal dialysis as a means to filter toxins from the blood once the kidneys have failed. Without dialysis or transplant, kidney failure results in the accumulation of waste products that may ultimately cause death. Hemodialysis, the most common form of dialysis, generally requires a patient to visit a dialysis center at least three times per week for a minimum three-hour session, significantly impacting quality of life.
There are currently estimated to be more than 35 million people in the U.S. suffering from chronic kidney disease, more than 550,000 of whom are treated with dialysis.
What is Hyperphosphatemia?
Hyperphosphatemia, a nearly universal condition among patients with CKD on dialysis, is an electrolyte disorder in which there is an elevated level of phosphate in the blood. Hyperphosphatemia is a major independent risk factor for cardiovascular morbidity and mortality in patients on dialysis. In fact, cardiovascular disease is the leading cause of death in this patient population and traditional risk factors alone do not explain the high rates of cardiovascular disease. Hyperphosphatemia has emerged as a predominant and modifiable risk factor for cardiovascular morbidity and mortality, and as such, effective management of serum phosphorus is critical for patients with CKD on dialysis.
While dialysis is the basis for homeostatic electrolyte management, dialysis regimens are unable to successfully remove excess phosphate in order to achieve a neutral phosphate balance. As a result, approximately 80% of patients with CKD on dialysis require phosphate-lowering therapy on top of restrictive, low phosphorus diets.
Despite widespread treatment with currently available therapies, a significant proportion of patients are unable to achieve and maintain target phosphorus levels. While the 2017 KDIGO clinical practice guidelines recommend lowering elevated phosphate levels toward the normal range (2.5-4.5 mg/dL or 0.81-1.45mmol/L), due to the difficulties in managing phosphorus, most clinicians target phosphorus levels between 3.5-5.5 mg/dL (1.13-1.78 mmol/L), based on the 2003 KDOQI clinical practice guidelines. Even the less aggressive targets are often unachievable today with approximately 40% of patients having phosphorus levels >5.5 mg/dL (1.78 mmol/L) in any given month, and approximately 80% of patients unable to consistently maintain phosphorus levels ≤5.5 mg/dL (1.78 mmol/L) over a 6-month period.
Currently available treatments all belong to the class of drugs referred to as phosphate binder therapies. Achieving and maintaining effective phosphate control with phosphate binders is extremely challenging. Phosphate binders act by binding dietary phosphorus in the gut. The binding mechanism requires frequent dosing and often, many large pills in order to bind enough phosphorus, making phosphate binders the largest contributor to excessive pill burden for patients on dialysis. Phosphate binders also tend to be associated with a number of GI side effects including nausea, vomiting, abdominal pain, diarrhea, and constipation.
Here at Ardelyx, we have discovered that the paracellular pathway is the primary mechanism by which dietary phosphorus is absorbed. By developing first-in-class therapeutics to specifically target and block phosphorus absorption through the paracellular pathway, we hope to address what continues to be a significant unmet medical need in patients on dialysis.
What is Hyperkalemia?
Hyperkalemia is a potentially life-threatening condition in which blood levels of potassium are elevated above normal. Potassium is a nutrient that is critical to the normal function of nerve and muscle cells, including those in the heart. Normal potassium blood levels are tightly balanced and maintained primarily by the kidneys. For people with chronic kidney disease (CKD), heart failure, and diabetes, and particularly those also taking highly beneficial renin-angiotensin-aldosterone system (RAAS) inhibitors, there is a greater risk of developing hyperkalemia due to side effects and the kidney’s limited ability to keep potassium in balance.
Because of the risk of hyperkalemia, several published guidelines have suggested that physicians should reduce and possibly discontinue RAAS inhibitors in order to manage the risk of hyperkalemia in CKD and heart failure patients. The alternative medications used to control hypertension, including diuretics and calcium channel blockers, are less effective than RAAS inhibitors, particularly in patients with failing kidneys and severe hypertension.
According to the 2015 publication Market Dynamix: Hyperkalemia, released by Spherix Global Insights, U.S. cardiologists reported that of the patients who would benefit from RAAS inhibition, up to 38% of patients with heart failure and up to 55% of patients with both heart failure and CKD are being administered a sub-optimal dose or none at all. Nephrologists reported that at least one-third of patients who would benefit from RAAS inhibition receive a sub-optimal dose or none at all. We believe there is clearly a strong medical need for new medications that control hyperkalemia in order to allow for optimal use of RAAS inhibitors to control hypertension in these patient populations.
It is estimated that 2.1 million people in the U.S. with CKD and/or heart failure have hyperkalemia, which remains an emerging and unaddressed market with today’s treatments.
What is IBSRELA®?
IBSRELA® (tenapanor) 50 mg tablets is a prescription medicine used in adults to treat Irritable Bowel Syndrome with Constipation (IBS-C). It is not known if IBSRELA is safe and effective in children less than 18 years of age.
Irritable bowel syndrome with constipation (IBS-C) is a gastrointestinal disorder characterized by significant abdominal pain and constipation. IBS-C significantly impacts the health and quality of life of affected patients. The cause of IBS-C is unknown, and there are currently no specific diagnostic tests or biomarkers for detection. Therefore, IBS-C is diagnosed by symptoms and by eliminating other disorders. It is estimated that there are ~11 million people in the U.S. with IBS-C.
IMPORTANT SAFETY INFORMATION
- Do not give IBSRELA to children who are less than 6 years of age. It may harm them.
- You should not give IBSRELA to patients 6 years to less than 18 years of age. It may harm them. IBSRELA can cause severe diarrhea and your child could get severe dehydration (loss of a large amount of body water and salt).
- Do not take IBSRELA if a doctor has told you that you have a bowel blockage (intestinal obstruction).
Before you take IBSRELA, tell your doctor:
- If you have any other medical conditions
- are pregnant or plan to become pregnant. It is not known if IBSRELA will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if IBSRELA passes into your breast milk. Talk with your doctor about the best way to feed your baby if you take IBSRELA®.
- Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
- Diarrhea is the most common side effect of IBSRELA, and it can sometimes be severe. Stop taking IBSRELA and call your doctor if you develop severe diarrhea.
The other most common side effects of IBSRELA include:
- swelling, or a feeling of fullness or pressure in your abdomen (distension).
- gas (flatulence).
These are not all the possible side effects of IBSRELA. Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to www.fda.gov/medwatch or you can report side effects to Ardelyx at 1-844-427-7352.
Please also see Medication Guide within the full Prescribing Information.
What is IBS-C?
Irritable bowel syndrome with constipation (IBS-C) is a gastrointestinal disorder characterized by significant abdominal pain and constipation (when a bowel movement is difficult due to insufficient/decreased amount of fluid in the GI, or happens less often than normal). IBS-C significantly impacts the health and quality of life of affected patients. The cause of IBS-C is unknown, and there are currently no specific diagnostic tests or biomarkers for detection. Therefore, IBS-C is diagnosed by symptoms and by eliminating other disorders. IBS-C is similar to chronic constipation but is clinically distinct as a result of the significant abdominal pain component.
It is estimated there are ~11 million people in the U.S. with IBS-C, which results in a major reduction in health-related quality of life and work productivity – patients, on average, experience ~5 days per month disrupted productivity due to GI symptoms.
Investigator Sponsored Trials
To submit an IST concept, please download this application and email the completed form to IST@ardelyx.com.
Current Areas of IST Research Interest:
- IBS-C Mechanism of Disease
- IBSRELA MoA
- Management of IBS-C
- Clinical Outcomes of IBS-C Management
- Novel Uses for Tenapanor
Grants & Giving
As part of the Ardelyx commitment to the medical and patient community, we support independent medical education (IME) for professionals and independent educational programs for patients and caregivers.
IME is professional education given by accredited medical education providers who design and implement programs independent of Ardelyx influence, as defined by standards such as the Accreditation Council for Continuing Medical Education (ACCME) guidelines, the FDA’s Guidance: Industry Supported Scientific and Educational Activities, and the PhRMA Code.
Current Areas of Interest Are:
- Understanding IBS-C Mechanism of Disease
- Understanding Barriers in the Treatment of IBS-C
- Understanding Hyperphosphatemia Mechanism of Disease
- Understanding Advances in the Management of Hyperphosphatemia
- Understanding Barriers to Treatment in Hyperphosphatemia
We are currently accepting grant requests.
Educational grant requests may be submitted to https://grantsandgiving.ardelyx.com/.
Ardelyx may provide financial support for qualified community or healthcare-related charitable organizations for a bona fide philanthropic purpose to promote the public good in line with Ardelyx funding priorities.
Charitable grant requests may be submitted to https://grantsandgiving.ardelyx.com/.