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Alfasigma USA Acquires ZELNORMTM (tegaserod) for Reintroduction to the US Market

Bedminster, NJ, July 8, 2019 – Alfasigma USA, Inc. today announced it has acquired the brand ZELNORM, a prescription pharmaceutical treatment for irritable bowel syndrome with constipation (IBS-C), from Sloan Pharma S.à r.l., a subsidiary of US WorldMeds Holdings, LLC. Plans to relaunch ZELNORM in the United States are currently underway.

Originally approved in 2002 as the first prescription medication for IBS-C, ZELNORM was voluntarily withdrawn from the market in 2007 due to concerns regarding possible cardiovascular risk; however, the drug has remained available in the US through an expanded access program authorized by the FDA. In early 2019, ZELNORM was approved by the FDA for reintroduction for use in adult women (< 65 years of age) with IBS-C. The approval to reintroduce ZELNORM came after a thorough safety review by the FDA and an FDA-assembled Gastrointestinal Drugs Advisory Committee (GIDAC). The evaluation consisted of a review of the clinical data from 29 placebo-controlled trials and post-marketing treatment outcomes data.

“We are excited by the opportunity to make ZELNORM once again available to healthcare providers to treat adult women in the US suffering from IBS-C,” said Bryan Downey, President and Chief Executive Officer at Alfasigma USA. “There is a substantial unmet need for IBS-C therapies with reliable efficacy, comparable safety, and that help address the debilitating pain and bloating associated with the disease. We look forward to making this effective IBS-C treatment available to the patients who may benefit the most.”

ZELNORM is the only selective serotonin-4 (5-HT4) receptor agonist approved to treat IBS-C. It provides a unique treatment by targeting the 5-HT4 receptor at multiple neurons (sensory, motor, secretory motor) and smooth muscle cells in the gastrointestinal tract to induce contraction and relaxation, and decrease pain signaling.

“We believed in the value of ZELNORM and invested a tremendous amount of time and effort to receive FDA approval for reintroduction and support for the revised indication in March, 2019. The commercial capabilities of Alfasigma USA make it the right organization to reintroduce ZELNORM to the US market,” stated Hans van Zoonen, Manager of the Switzerland Branch of Sloan Pharma, S.à r.l.

IBS is prevalent in 7-21% of adults worldwide and in 5-9% of US adults. Its prevalence has increased over the past several decades and is particularly high in adult female patients less than 50 years of age.1-5 IBS is associated with substantially impaired quality of life, including effects on lifestyle, daily activities, and sleep, as well as work absenteeism.

According to Mr. Downey, “The reintroduction of ZELNORM is a first step in fulfilling our promise to find prescription pharmaceutical opportunities for Alfasigma in the US. With ZELNORM, our Alfasigma corporate slogan ‘Pharmaceuticals with Passion’ is now as meaningful in the US as it is globally.”

Alfasigma USA looks forward to making ZELNORM available by prescription in the coming weeks. For more information, please see the Medication Guide and full Prescribing Information for ZELNORM at www.zelnormus.com.

About Alfasigma USA, Inc.

Alfasigma USA, Inc. is the American affiliate of Alfasigma, a leading Italian pharmaceutical company. Alfasigma is present in more than 90 countries, with a workforce of around 3,000 people and 5 manufacturing plants. Alfasigma USA, Inc. distributes a portfolio of prescription nutritional products to help individuals who are suffering from GI disorders (VSL#3®), major depressive disorder (DEPLIN®), diabetic peripheral neuropathy (METANX®), and mild cognitive impairment (CerefolinNAC®). With the acquisition of ZELNORMTM, Alfasigma USA is building on their commitment to making ‘Pharmaceuticals with Passion’ in the US. For more information, please visit www.alfasigmausa.com or email info@alfasigma.com.

About Sloan Pharma, S.à r.l.

Sloan Pharma, S.à r.l. is a subsidiary of US WorldMeds Holdings, LLC, a specialty pharmaceutical company whose products are making a difference in the lives of the patients and communities it serves. US WorldMeds takes an agile and personal approach to pharmaceuticals – pioneering research and product development in therapeutic areas that desperately need new solutions. Headquartered in Louisville, Kentucky, US WorldMeds has global presence and nearly 20 years of experience in the development, licensure, and commercialization of unique products. For more information about US WorldMeds, visit https://www.usworldmeds.com/.

ZELNORM Indications and Usage:

ZELNORM is indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C).

ZELNORM Important Safety Information

To report SUSPECTED ADVERSE REACTIONS or product complaints, contact Alfasigma USA at 855-697-9232. You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information and Medication Guide at www.zelnormus.com.

  1. Hungin AP, et al. Aliment Pharmacol Ther. 2003;17(5):643-50.
  2. Halder SL, et al. Gastroenterology. 2007;133(3):799-807.
  3. Ford AC, et al. Am J Gastroenterol. 2008;103(5):1229-39.
  4. Lovell RM, Ford AC. Clin Gastroenterol Hepatol. 2012;10(7):712-21.e4.
  5. Mearin F, et al. Gastroenterology. 2016. doi:10.1053/j.gastro.2016.02.031 ahead of print]. [Epub ahead of print].