NEW ORLEANS, LA – The U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for AMITIZA® (lubiprostone), granting it Priority Review designation for the treatment of pediatric functional constipation in children aged 6 to 17. If approved, AMITIZA will become the first and only prescription medication specifically indicated for this patient population, addressing a long-standing gap in pediatric care. DelRicht Research contributed to the pediatric clinical trial through the participation of Dr. Patrick Dennis, Principal Investigator at Touro Medical Center in New Orleans, LA.

Dr. Dennis has led multiple clinical studies with DelRicht Research across a wide range of therapeutic areas, including gastrointestinal, metabolic, and pediatric conditions.

DelRicht Research on Expanding Options for Pediatric Gastroenterology

Pediatric functional constipation is a common and often frustrating condition for families and providers alike. While dietary and behavioral strategies can offer some relief, many children struggle to find consistent, effective treatment. AMITIZA, a chloride channel activator, works locally in the small intestine to increase fluid secretion and intestinal motility, easing the passage of stool and relieving symptoms of constipation.

Sucampo Pharmaceuticals’ submission of the sNDA follows a robust clinical development program that demonstrated AMITIZA’s safety and efficacy in the pediatric population. The Priority Review designation underscores the significant need for FDA-approved therapies for children and signals an expedited timeline for potential approval. “Children with functional constipation and their families often face years of trial and error in search of reliable relief,” said Rachel Hastings, Managing Partner at DelRicht Research. “We’re proud that DelRicht sites, including Dr. Dennis, contributed to this important study and helped lay the foundation for a potential first-in-class treatment for these young patients.”

“Children with functional constipation and their families often face years of trial and error in search of reliable relief. We’re proud that DelRicht sites, including Dr. Dennis, contributed to this important study and helped lay the foundation for a potential first-in-class treatment for these young patients.”

— Rachel Hastings, Managing Partner at DelRicht Research

Local Expertise Driving Pediatric Innovation

Dr. Dennis’s contributions to the AMITIZA pediatric trial build on a deep history of clinical research excellence at Touro Medical Center. His longstanding relationship with DelRicht Research has enabled consistent site performance across high-complexity trials, including those in underserved or difficult-to-enroll populations. “AMITIZA is a long-awaited prescription option for children struggling with functional constipation,” said Dr. Patrick Dennis, Principal Investigator. “I’m grateful to have been part of a study that could make a real difference in pediatric GI care.”

“If approved, AMITIZA would be a long-awaited prescription option for children struggling with functional constipation. I’m grateful to have been part of a study that could make a real difference in pediatric GI care.”

— Dr. Patrick Dennis, Principal Investigator at DelRicht Research

Sucampo also plans to continue its pediatric research program with AMITIZA in children as young as 6 months, highlighting the growing interest in safe, effective treatments tailored to younger patients.

A First-of-Its-Kind Pediatric Option on the Horizon

The FDA’s Priority Review decision places AMITIZA’s pediatric indication on track for a January 2018 decision. If approved, it would fill a critical unmet need for children aged 6–17 with persistent constipation that is unresponsive to lifestyle modifications or over-the-counter options.

DelRicht Research and its principal investigators remain committed to advancing pediatric research and supporting innovative therapies that meet the needs of both patients and families.

Read the full press release on GlobeNewswire.