QOL Medical announced the U.S. Food and Drug Administration (FDA) has approved its new, state-of-the-art manufacturing facility in Florida and the supply of Sucraid (sacrosidase) Oral Solution has been restored. QOL Medical is now able to meet all prescription demand for Sucraid nationwide without informed consent.
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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. "Since Sucraid is the only FDA-approved enzyme replacement therapy for this condition."