FDA approves the reintroduction of Zelnorm™ (tegaserod) for Irritable Bowel Syndrome with Constipation (IBS-C) in women under 65

LOUISVILLE, Ken., April 1, 2019 /PRNewswire/ -- US WorldMeds has announced that Sloan Pharma, S.a.r.l., a subsidiary of US WorldMeds Holdings, LLC, has received approval from the U.S. Food and Drug Administration (FDA) for the reintroduction of Zelnorm™ (tegaserod), a twice-daily oral treatment for Irritable Bowel Syndrome with Constipation (IBS-C) in women under 65.

Zelnorm was originally approved by the FDA in 2002 for the treatment of IBS-C in women. Despite usage that made Zelnorm the prescription market leader in IBS-C, it was voluntarily withdrawn from the U.S. market in 2007 due to a potential safety signal. Zelnorm has remained consistently available in the U.S. through an expanded access program authorized by the FDA and is used by IBS-C patients in several other countries.

Approval to reintroduce Zelnorm comes after a complete safety review by the FDA and an FDA-assembled Gastrointestinal Drugs Advisory Committee (GIDAC). The review focused on the evaluation of clinical data from 29 placebo-controlled trials and newly-available sources of treatment outcome data. A positive GIDAC vote and FDA review both supported the reintroduction of Zelnorm for appropriate IBS-C patients.

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. In clinical trials, patients taking Zelnorm saw improvement in some of the most bothersome IBS-C symptoms; in the first four weeks significantly more Zelnorm-treated patients than placebo-treated patients reported an improvement in their abdominal pain/discomfort and bloating. Frequency of bowel movements also increased from a median number of 3.8 per week at baseline to 6.3 per week at month one.

"We are excited about what the reintroduction of Zelnorm means for patients suffering from irritable bowel syndrome with constipation. We have continually heard from patients and clinicians alike that the IBS-C community is eager to have Zelnorm return to the U.S. as an available treatment option," said P. Breckinridge Jones, CEO of US WorldMeds.

Jeffery Roberts, patient advocate and founder of the IBS Patient Group, stated, "The re-approval of Zelnorm is very good news for patients. We believe it will provide renewed access to a treatment option where other new medications have been insufficient for meeting patients' needs."

Zelnorm was acquired by Sloan Pharma from Novartis in 2015. Sloan is the exclusive licensee of Zelnorm and US WorldMeds, LLC is the exclusive distributor of Zelnorm in the United States and Its territories. Zelnorm is a trademark of US WorldMeds, LLC. Zelnorm will be available by prescription for patients in the coming months. For more information contact 855-697-9232 or visit www.zelnormus.com

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).

Important Safety Information

• Do not take ZELNORM if you:
• have had a heart attack, stroke, transient ischemic attack (TIA), angina, inflammation and injury of the intestines caused by reduced blood flow to the intestines (ischemic colitis), intestinal blockage (bowel obstruction), gallbladder problems that caused symptoms, or scar tissue that formed between the tissues and other organs in the abdomen;
• have severe kidney problems or end-stage kidney disease, or moderate or severe liver problems;
• have or may have had a problem with the muscular valve that controls the flow of digestive juices to the first part of your intestine (sphincter of Oddi); or
• are allergic to tegaserod.
• ZELNORM can cause serious side effects. Major cardiovascular events, such as stroke, heart attack, and death have happened in adults taking ZELNORM who had an increased risk of a cardiovascular event. Talk to your healthcare provider about risk factors you may have before you start taking ZELNORM and get emergency medical help right away if you have signs or symptoms of a heart attack, stroke, mini stroke (TIA), or angina (chest pain caused by your heart not getting enough oxygen).
• Ischemic colitis and other problems of the intestines have happened in some people taking ZELNORM. Stop taking ZELNORM and get medical help if you have symptoms such as rectal bleeding, bloody diarrhea, or new or worsening stomach-area (abdominal) pain.
• Diarrhea is a common side effect of ZELNORM, and it can sometimes be severe. Stop taking ZELNORM and call your healthcare provider right away if you have severe diarrhea, especially if you also feel lightheaded or dizzy, or if you faint.
• ZELNORM may increase the risk of suicidal thoughts and behavior. You, your caregiver, and your family should monitor you for changes in behavior. If you have any new or worsening symptoms of depression, unusual changes in mood or behavior, begin to have suicidal thoughts or behavior, or thoughts of self-harm, stop taking ZELNORM right away and tell your healthcare provider.
• Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if ZELNORM will harm your unborn baby.
• Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if ZELNORM passes into breast milk. You should not breastfeed if you take ZELNORM.
• The most common side effects of ZELNORM are headache, abdominal pain, nausea, diarrhea, flatulence, dyspepsia, and dizziness.

To report SUSPECTED ADVERSE REACTIONS or product complaints, contact US WorldMeds 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

About ZELNORM (tegaserod)
ZELNORM is a serotonin-4 (5-HT4) receptor agonist indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C). Results in three double-blind, placebo-controlled trials with 2,470 adult women showed improvement in symptoms from baseline after a month of treatment with Zelnorm, compared to placebo. Zelnorm is a twice daily oral tablet that should be taken at least 30 minutes prior to meals. Safety and effectiveness of Zelnorm in men with IBS-C have not been established.

About IBS-C
Irritable bowel syndrome with constipation (IBS-C), according to the American College of Gastroenterology, is characterized as abdominal discomfort associated with altered bowel habits.² It is estimated that approximately 5% of the US population is affected by IBS-C.² Constipation and/or abdominal pain/discomfort tend to be the most bothersome symptoms for patients.³ Many IBS-C patients are frustrated by their disease and experience bothersome symptoms that directly impact their productivity and quality of life.²

About US WorldMeds
US WorldMeds is 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 http://www.usworldmeds.com/. Follow US WorldMeds on Twitter, LinkedIn and Facebook.

About Sloan Pharma
Sloan Pharma, S.a.r.l. is a subsidiary of US WorldMeds Holdings, LLC, and sister company to US WorldMeds, LLC.

¹ Defined as a patient's self-rating of considerably or completely relieved for at least 2/4 weeks, or at least somewhat relieved for 4/4 weeks within first month of treatment.
² Quigley EMM, Horn J, Kissous-Hunt M, Crozier RA, Harris LA. Better Understanding and Recognition of the Disconnects, Experiences, and Needs of Patients with Irritable Bowel Syndrome with Constipation (BURDEN IBS-C) Study: Results of an Online Questionnaire. Adv Ther 2018; 35: 967-80.
³ Tack et al. A randomised controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation. Gut. 2005;54: 1707-1713.

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SOURCE US WorldMeds

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