The US Food and Drug Administration (FDA) has approved Digestive Care Inc's (DCI) New Drug Application (NDA) for Pertzye, indicated for the treatment of Exocrine Pancreatic Insufficiency (EPI) due to cystic fibrosis (CF) or other conditions.

Pertzye is a unique pancreatic enzyme product containing bicarbonate-buffered enteric-coated microspheres and is protected by several US and international patents. The Pertzye formulation was previously marketed by DCI for over a decade under the trade name Pancrecarb MS-16.

Dr Tibor Sipos, president and chief scientific officer at DCI stated, “The approval of Pertzye represents a significant milestone for DCI. This achievement confirms our commitment to the continued development of products vital to the well being of patients living with chronic diseases.”

The short-term safety and efficacy of Pertzye were evaluated in a randomized, multi-centre, double-blind, placebo-controlled, crossover study conducted in patients ages 8 to 43 years with EPI due to CF. The primary efficacy endpoint was the mean difference in coefficient of fat absorption (CFA) between Pertzye and placebo treatment. Mean CFA was 83 per cent with Pertzye treatment compared to 46 per cent with placebo treatment (p<0.001).

“The improvement in mean CFA observed in the controlled study represents a clinically meaningful treatment benefit for patients using Pertzye. Availability of this unique buffered formulation of pancreatic enzyme is an important addition to the therapeutic options for CF and other patients with EPI,” stated Michael W Konstan, MD, chairman of Paediatrics, Rainbow Babies and Children's Hospital and Case Western Reserve University School of Medicine, Cleveland, Ohio.

DCI is a fully integrated pharmaceutical company, dedicated to developing unique pharmaceutical products to alleviate complications and symptoms of gastrointestinal disorders.