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14 October, 2019 00:00 00 AM

FDA approves Ibsrela (tenapanor) for the treatment of Irritable Bowel Syndrome with constipation

drugs.com
FDA approves Ibsrela (tenapanor) for the treatment of Irritable Bowel Syndrome with constipation

Ardelyx, Inc. recently announced that the U.S. Food and Drug Administration has approved Ibsrela (tenapanor), a 50 mg, twice daily oral pill for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults. Ibsrela is a minimally-absorbed small molecule that acts locally in the gastrointestinal (GI) tract to inhibit the sodium-hydrogen exchanger NHE3, resulting in an increase in bowel movements and a decrease in abdominal pain for IBS-C patients.

"Ibsrela has the potential to provide IBS-C patients and their doctors with a novel mechanism and an innovative approach to managing IBS-C, a highly burdensome and difficult-to-treat condition affecting more than 11 million people in the United States," commented Mike Raab, president and chief executive officer of Ardelyx.  "This approval is an extremely important and rewarding milestone for Ardelyx, and represents the culmination of years of dedication to advancing our discoveries and medicines in an effective and rigorous manner. We look forward to establishing a commercial collaboration with a partner that has the capabilities to drive the successful launch and marketing of Ibsrela in this large and underserved IBS-C patient population."

Mr. Raab continued, "With the approval of Ibsrela for IBS-C, along with the successful completion of our AMPLIFY trial in hyperphosphatemia, we've delivered on two major corporate milestones in the last two weeks due to flawless execution by the remarkable and talented team at Ardelyx. With these milestones accomplished, and the PHREEDOM trial reading out in Q4, I have great confidence that we are well positioned to file our NDA for hyperphosphatemia next year with potential approval and launch in 2021. We are excited about this next chapter for Ardelyx as we begin the development of our playbook for launch and commercialization of tenapanor for hyperphosphatemia in chronic kidney disease patients on dialysis and are excited to begin sharing more of our vision in the coming months."

Indications and Usage

Ibsrela (tenapanor) is indicated for treatment of irritable bowel syndrome with constipation (IBS-C) in adults.

Important Safety Information

Ibsrela is contraindicated in patients less than 6 years of age; in young juvenile rats, tenapanor caused death 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 pediatric patients less than 18 years of age.

Contraindications

Ibsrela is contraindicated in pediatric patients less than 6 years of age.

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.

Adverse reactions

In the two IBS-C trials, the most common adverse reaction in Ibsrela-treated patients (incidence ≥2% and greater than in the placebo group) was diarrhea (Trial 1: 16% Ibsrela vs 4% placebo; Trial 2: 15% Ibsrela vs 2% placebo).

 

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Editor : M. Shamsur Rahman

Published by the Editor on behalf of Independent Publications Limited at Media Printers, 446/H, Tejgaon I/A, Dhaka-1215.
Editorial, News & Commercial Offices : Beximco Media Complex, 149-150 Tejgaon I/A, Dhaka-1208, Bangladesh. GPO Box No. 934, Dhaka-1000.

Editor : M. Shamsur Rahman
Published by the Editor on behalf of Independent Publications Limited at Media Printers, 446/H, Tejgaon I/A, Dhaka-1215.
Editorial, News & Commercial Offices : Beximco Media Complex, 149-150 Tejgaon I/A, Dhaka-1208, Bangladesh. GPO Box No. 934, Dhaka-1000.

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