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Alfasigma USA, Inc. today announced that 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. Alfasigma USA acquired ZELNORM from Sloan Pharma S.à r.l., a subsidiary of US WorldMeds Holdings, LLC, in July 2019.
“We are pleased to inform U.S. physicians and pharmacists about the reintroduction of ZELNORM and how Alfasigma USA is supporting the availability, access to, and appropriate use of this important medicine for the many patients who cope daily with an urgent need for new treatment options,” said Bryan Downey, president and chief executive officer at Alfasigma USA. “Our growing U.S. organization and national sales force is excited to lead the return of ZELNORM and committed to making a positive difference in the lives of patients.”
Originally approved in 2002 as the first prescription medication for IBS-C, ZELNORM was voluntarily withdrawn from the market in 2007 due to concerns regarding possible cardiovascular risk.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 U.S. 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 addresses an area of clear unmet medical need and there is a robust body of data supporting its safe and effective use when used as indicated for adult women in the U.S. suffering from IBS-C,” said John Kincaid M.D., head of medical affairs at Alfasigma USA.
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.
For healthcare providers seeking more information on ZELNORM, visit www.zelnormhcp.com.
For patients seeking more information on ZELNORM, visit www.myzelnorm.com.
About IBS and IBS-C
IBS is prevalent in 7-21 percent of adults worldwide and in 5-9 percent of U.S. 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.5
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 certain GI disorders (VSL#3®), major depressive disorder (DEPLIN®), diabetic peripheral neuropathy (METANX®), and mild cognitive impairment (CerefolinNAC®). For more information, please visit www.alfasigmausa.com or email email@example.com.
What is ZELNORM?
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).
Important Safety Information
Do not take ZELNORM if you:
What are the possible side effects of ZELNORM?
ZELNORM can cause serious side effects, including:
The most common side effects of ZELNORM are headache, stomach-area (abdominal) pain, nausea, diarrhea, gas, indigestion, and dizziness.
Before you take ZELNORM, tell your healthcare provider:
To report possible adverse reactions, contact Alfasigma USA at 1-855-697-9232. You may also report possible adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please also see the Medication Guide within the full Prescribing Information.
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. Lacy BE, et al. Gastroenterology. 2016 [Epub ahead of print].
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