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IMPORTANT SAFETY INFORMATION:

Press Release

QOL Medical, LLC Receives FDA Approval of Sucraid® (sacrosidase) Oral Solution Single-Use Containers for Patients with Congenital Sucrase-Isomaltase Deficiency (CSID)

Vero Beach, Florida—(PR NEWSWIRE)—QOL Medical, LLC, a ground-breaking, rare disease pharmaceutical company, announced today that the United States (U.S.) Food & Drug Administration (FDA) approved Sucraid® single-use containers for patients more than 33 lb (15 kg) with Congenital Sucrase-Isomaltase Deficiency (CSID).

Currently, Sucraid® (sacrosidase) Oral Solution is the only pharmaceutical treatment for CSID in children and adults. Sucraid® is an enzyme replacement therapy for genetically determined sucrase deficiency, which is part of CSID. Sucraid® helps the breakdown and absorption of sucrose (table sugar) from the intestine, which relieve the gastrointestinal symptoms of CSID. Now Sucraid® is available in both Sucraid® multi-dose bottles and Sucraid® single-use containers. More information can be found at www.sucraid.com.

“If untreated, patients living with this chronic condition suffer from debilitating symptoms. We are always looking for ways to improve their quality of life. These new single-use containers will make it easier for them to manage their medication.” said Weng Tao, MD, PhD, COO of QOL Medical, LLC. “FDA’s approval of Sucraid® single-use containers, with three-day room temperature stability, offer greater convenience for CSID patients on the go.”

People with CSID are unable to properly digest sucrose (table sugar), which is found naturally in many fruits and vegetables, as well as added to many processed foods. In adolescents and adults, CSID has been characterized by symptoms of chronic abdominal pain, gas, loose stools, and diarrhea, which overlap with common irritable bowel syndrome (IBS) symptoms. In infants, CSID classically presents as explosive watery diarrhea, failure to thrive, diaper rash, irritability, and acidic stools.

Important Safety Information

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 treated with SucraidÒ 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 FDA.gov/medwatch or call 1-800-FDA-1088.

Click here to read our full prescribing information Sucraid® PI.

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]

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Important Safety Information for Sucraid® (sacrosidase) Oral Solution

  • 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).
  • 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 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 treated with Sucraid® may have worse abdominal pain, vomiting, nausea, or diarrhea. Constipation, difficulty sleeping, headache, nervousness, and dehydration have also occurred in patients treated with Sucraid®. 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 just 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; single-use containers can be removed from refrigeration and stored at 59°F-77°F (15°C-25°C) for up to 3 days (72 hours). Refer to Instructions for Use for full information on how to take Sucraid®.

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.

Indication

Sucraid® (sacrosidase) Oral Solution is indicated for the treatment of sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID), in adult and pediatric patients 5 months of age and older.