Alfasigma USA Announces ZELNORM™ (tegaserod) Now Available for Treatment of Irritable Bowel Syndrome with Constipation

August 16, 2019 Off By BusinessWire

ZELNORM approved by FDA in March 2019 after thorough safety review
Alfasigma USA has begun national reintroduction of ZELNORM to prescribers
ZELNORM now widely available through wholesale channels and retail pharmacy orders

BEDMINSTER, N.J.–(BUSINESS WIRE)–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Originally approved in 2002 as the first prescription medication for IBS-C, ZELNORM was voluntarily withdrawn from the market in 2007 due to concerns regarding possible cardiovascular risk.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 protected].

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:

have had a heart attack, stroke, transient ischemic attack (TIA), angina.
have severe kidney problems or end-stage kidney disease, or moderate or severe liver problems.
have or have had 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 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).
are allergic to ZELNORM.

What are the possible side effects of ZELNORM?

ZELNORM can cause serious side effects, including:

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.

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:

if you are pregnant or plan to become pregnant. It is not known if ZELNORM will harm your unborn baby.
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.
if you are an active smoker.
if you have or have had high blood pressure or are taking medicine to lower your blood pressure.
if you have or have had high blood cholesterol levels or are taking medicine to lower your blood cholesterol levels.
if you have or have had diabetes.
if you are having diarrhea or have diarrhea often.

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].

08/2019 ZEL19-013