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FDA Grants Orphan Drug Designation to New Treatment for Short Bowel Syndrome
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The FDA has granted orphan drug designation to NTRA-9620, a new orally administered treatment for short bowel syndrome in patients of all ages, the manufacturer announced today.
Infants with short bowel syndrome (SBS) are currently treated with nutritional, pharmacologic and surgical interventions to promote enteral nutrition but minimize related complications, according to a press release. However, many patients rely on long-term parenteral treatment, which is associated with complications and significant economic burden to families and the health care system.
NTRA-9620 (Nutrinia) thus intends to improve post-resection bowel adaptation and outcomes in SBS patients in part by reducing patient dependence on parenteral nutrition support and increasing enteral nutrition intake, according to the release. The active ingredient is insulin formulated to deliver targeted treatment in the local gastrointestinal tract without systemic exposure. “The route of insulin administration is known to play a key role in supporting the maturation and rehabilitation of the GI tract,” the release said.
“Receiving Orphan Drug Designation in the U.S. market for the development of our SBS therapy, NTRA-9620, to benefit SBS patients represents a significant milestone for Nutrinia,” Miki Olshansky, CEO of Nutrinia, said in the release. “As a first step, we are working closely with leading neonatologists, gastroenterologists and surgeons, as well as U.S.A. FDA to finalize the design of our upcoming trial of NTRA-9620 in infants with SBS.”
The company plans to launch a U.S. and European multinational study following its investigational new drug application, as well as a clinical program of NTRA-2112 for GI malabsorption caused by intestinal immaturity in preterm infants, the release said.
“We believe that both of our lead development programs have the potential to safely enhance bowel adaptation and nutrients absorption to improve outcomes for both patient populations,” she added.
Disclosure: Olshansky reports he is an employee of Nutrinia.