Sucraid Single-Use Containers Approved for Congenital Sucrase-Isomaltase Deficienc

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The Food and Drug Administration (FDA) has approved Sucraid® (sacrosidase) Oral Solution single-use containers for patients weighing greater than 15kg with congenital sucrase-isomaltase deficiency (CSID).

Sucraid is an oral enzyme replacement therapy for the treatment of genetically determined sucrase deficiency, which is part of CSID. CSID is a chronic, autosomal recessive, inherited phenotypically heterogeneous disease with very variable enzyme activity.

In the absence of endogenous human sucrase, as in CSID, sucrose is not metabolized. Sucraid helps to improve the breakdown and absorption of sucrose from the intestine, which can help relieve the gastrointestinal symptoms of CSID.


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The new formulation of Sucraid Oral Solution is supplied as a 2mL single-use container containing 17,000 IU of sacrosidase packaged into a foil pouch. The single-use containers are supplied in a 150-count carton. 

“These new single-use containers will make it easier for [patients] to manage their medication,” said Weng Tao, MD, PhD, COO of QOL Medical, LLC. “FDA’s approval of Sucraid® single-use containers, with 3-day room temperature stability, offer greater convenience for CSID patients on the go.”

Sucraid Oral Solution is also available in 118mL (4 fluid ounces) multiple-dose bottles. Each mL of solution contains 8500 IU of sacrosidase.

References

  1. QOL Medical, LLC receives FDA approval of Sucraid® (sacrosidase) Oral Solution single-use containers for patients with Congenital Sucrase-Isomaltase Deficiency (CSID). News release. QOL Medical, LLC. Accessed September 7, 2022. https://www.prnewswire.com/news-releases/qol-medical-llc-receives-fda-approval-of-sucraid-sacrosidase-oral-solution-single-use-containers-for-patients-with-congenital-sucrase-isomaltase-deficiency-csid-301618690.html
  2. Sucraid. Package insert. QOL Medical, LLC; 2022. Accessed September 7, 2022. https://www.sucraidprescribinginformation.com/

This article originally appeared on MPR




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