19 August 2019 - - Italian pharmaceutical company Alfasigma's US-based Alfasigma USA, Inc.'s Zelnorm (tegaserod) is now available in the United States as a prescription pharmaceutical treatment for irritable bowel syndrome with constipation (IBS-C) in adult women less than 65 years of age, the company said.

Alfasigma USA acquired Zelnorm from Sloan Pharma S.à r.l., a subsidiary of US WorldMeds Holdings, LLC, in July 2019.

Originally approved in 2002 as the first prescription medication for IBS-C, Zelnorm was voluntarily withdrawn from the market in 2007 due to concerns regarding possible cardiovascular risk.

In March 2019, Zelnorm was approved for reintroduction in the US for use in adult women under 65 years of age with IBS-C, following a thorough safety review by the FDA and an FDA-assembled Gastrointestinal Drugs Advisory Committee (GIDAC). The evaluation consisted of a review of clinical data from 29 placebo-controlled trials and post-marketing treatment outcome data.

Zelnorm is the only serotonin-4 (5-HT4) receptor agonist approved to treat IBS-C. It targets 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.

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 under 50 years of age.1-5 IBS-C is characterized by frequent abdominal pain and altered bowel habits with predominant constipation; additional symptoms include bloating and distention.

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 five manufacturing plants.

Alfasigma USA, Inc. distributes a portfolio of prescription nutritional products to help individuals who are suffering from certain GI disorders (VSL#3), major depressive disorder (DEPLIN), diabetic peripheral neuropathy (METANX), and mild cognitive impairment (CerefolinNAC).

Zelnorm (tegaserod) is a prescription medicine used to treat adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C).