Sucraid® (Sacrosidase) Oral Solution, The Only FDA-Approved Therapy To Treat Congenital Sucrase-Isomaltase Deficiency (CSID), Is Now Available
VERO BEACH, Fla., Oct. 2, 2018 /PRNewswire/ -- QOL Medical, LLC today announced that the U.S. Food and Drug Administration (FDA) has approved its new, state-of-the-art manufacturing facility in Florida. The supply of Sucraid® (sacrosidase) Oral Solution has been restored. QOL Medical, LLC is now able to meet all prescription demand for Sucraid® nationwide without informed consent.
Congenital Sucrase-Isomaltase Deficiency (CSID) usually results in sucrose intolerance and gastrointestinal symptoms as a result of an individual's inability to properly digest sucrose (table sugar). Sucrose is found in a wide variety of foods including ice cream, apples, cake, corn, baked goods, and many processed foods common in Western diets. In adolescents and adults, CSID has been characterized by symptoms of chronic abdominal pain, gas, loose stools, and diarrhea. These symptoms are similar to, and can easily be confused with, those in mixed- and diarrhea-predominant irritable bowel syndrome (IBS), making an accurate differential diagnosis difficult. In infants, CSID classically presents as explosive watery diarrhea, failure to thrive, diaper rash, irritability, and acidic stools.
"FDA approval will provide broad access to a doctor-prescribed therapy for adults and children to help manage the symptoms of CSID," said Derick Cooper, CEO of QOL Medical, LLC, "since Sucraid® is the only FDA-approved enzyme replacement therapy for this condition."
Patients with a prescription may get a shipment of Sucraid® through the standard specialty pharmacy, US Bioservices, at 833-800-0122.
For more information, contact SucraidASSIST™ (Access and Support Services in Sucraid® Therapy) at 800-705-1962 or [email protected]. The SucraidASSIST™ program is designed to be the primary resource for Sucraid® patients, caregivers, and healthcare providers. One Patient Services manages the SucraidASSIST™ program to provide access to financial, peer, and dietary support for Sucraid® patients.
See Sucraid® Important Safety Information below.
About Sucraid®
Sucraid® (sacrosidase) Oral Solution is an enzyme replacement therapy for the treatment of genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID). Sucraid® can help improve the breakdown and absorption of sucrose (table sugar) from the intestine and can help relieve the gastrointestinal symptoms of CSID. www.sucraid.net
INDICATION
Sucraid® (sacrosidase) Oral Solution is an enzyme replacement therapy for the treatment of genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID).
IMPORTANT SAFETY INFORMATION FOR SUCRAID® (SACROSIDASE) ORAL SOLUTION
- Sucraid® may cause a serious allergic reaction. If you notice any swelling or have difficulty breathing, get emergency help right away.
- Sucraid® does not break down some sugars that come from the digestion of starch. You may need to restrict the amount of starch in your diet. Your doctor will tell you if you should restrict starch in your diet.
- Tell your doctor if you are allergic to, have ever had a reaction to, or have ever had difficulty taking yeast, yeast products, papain, or glycerin (glycerol).
- Tell your doctor if you have diabetes as your blood glucose levels may change if you begin taking Sucraid®. Your doctor will tell you if your diet or diabetes medicines need to be changed.
- Some patients may have worse abdominal pain, vomiting, nausea, or diarrhea. Constipation, difficulty sleeping, headache, nervousness, and dehydration have also occurred. Check with your doctor if you notice these or other side effects.
- Sucraid® has not been tested to see if it works in patients with secondary (acquired) sucrase deficiency.
- NEVER HEAT SUCRAID® OR PUT IT IN WARM OR HOT BEVERAGES OR INFANT FORMULA. Do not mix Sucraid® with fruit juice or take it with fruit juice. Take Sucraid® as prescribed by your doctor. Normally half of the dose of Sucraid® is taken before a meal or snack and the other half is taken during the meal or snack.
- Sucraid® should be refrigerated at 36°F-46°F (2°C-8°C) and should be protected from heat and light.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
Click here for Sucraid® full prescribing information.
About CSID
Congenital sucrase-isomaltase deficiency (CSID), often referred to as Sucrose Intolerance, is an inherited disorder that causes fewer than normal amounts of certain digestive enzymes to be present. These enzymes are required to break down and absorb carbohydrates in your diet like table sugar (sucrose) and other sugars from starches present in foods such as potatoes and baked goods. If you have CSID and eat foods with sugars and starches, you may experience diarrhea, gas, bloating, and abdominal pain.
About QOL Medical, LLC
QOL Medical is a specialty biopharmaceutical company dedicated to improving clinical outcomes and overall quality of life for patients with rare diseases. QOL Medical is a patient-centric company founded in 2003 to focus on the acquisition and commercialization of orphan and gastrointestinal products in underserved markets. Learn more at www.qolmed.com.
Sucraid® is a registered trademark of QOL Medical, LLC. All rights reserved.
Media Contact:
QOL Medical, LLC
Tiffany Carter
Phone: 818-720-8557
Email: [email protected]
Corporate Contact:
QOL Medical, LLC
3405 Ocean Drive
Vero Beach, FL 32963
Phone: 866-469-3773
Fax: 772-365-3375
Email: [email protected]
Specialty Pharmacy:
US Bioservices
Phone: 833-800-0122
https://www.usbioservices.com/contact-us
SOURCE QOL Medical, LLC
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