The SOLUTION study is designed to evaluate the non-inferiority of Sollpura compared to approved, porcine-derived, enterically-coated pancreatic enzyme replacement therapy when administered to patients with cystic fibrosis and exocrine pancreatic insufficiency. The study will enroll subjects who are receiving a pre-study PERT with which they achieve good fat absorption. The primary efficacy variable will evaluate the change from baseline in the coefficient of fat absorption following 6-week therapy with Sollpura compared with a porcine-derived PERT. Individualized doses of Sollpura and the PERT comparator will be chosen to match the lipase dose strength of the pre-study PERT. These doses may be further adjusted during the first 2 weeks of study based on clinical signs of malabsorption. The SOLUTION study will serve as the basis for an NDA approval if successful.
STATUS: Fully Enrolled
For latest updates, please go to Solutionstudy.com
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