Short Bowel Syndrome Therapy Designated Orphan Drug Status
Nutrinia announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to NTRA-9620, an orally-administered drug for treating short bowel syndrome (SBS).
The company plans to begin a pivotal clinical trial on the use of NTRA-2112 for short bowel syndrome. Nutrinia also has plans to run a separate, concurrent clinical program for NTRA-2112 for the treatment of gastrointestinal (GI) malabsorption caused by immaturity in preterm infants.
SBS is a malabsorption disorder caused by the surgical removal of a large portion of the small intestine, necrotizing enterocolitis (NEC), gastroschisis, atresia, and other congenital disorders. The current strategy for treating infants with SBS consists of nutritional, pharmacologic, and surgical interventions. These aim to promote enteral nutrition while minimizing the complications of parenteral nutrition therapy.
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