application): The overall objectives of this proposal are to (1) prepare a 25 kg batch of a buffered pancrelipase composition under good manufacturing practices (GMP) conditions for clinical supplies and (2) demonstrate the clinical efficacy of a buffered pancrelipase composition in reducing fecal fat excretion in 20 cystic fibrosis (CF) patients. The Food and Drug Administration requires at least one clinical trial to demonstrate the efficacy of pancrelipase-containing products in reducing steatorrhea (fat excretion in the stool) associated with CF patients in support of a new drug application (NDA) for market approval of a product. Digestive Care, Inc. has developed a new bicarbonate buffered pancrelipase composition in an enteric coated microsphere dosage form for CF patients. Results of three preliminary clinical trials support the greater efficacy of the newly developed bicarbonate buffered pancrelipase composition over other enzyme products that lack bicarbonate. A pivotal clinical study under controlled conditions needs to be completed for NDA approval.
NOT AVAILABLE
| Brady, Mary Sue; Garson, Jennifer L; Krug, Susan K et al. (2006) An enteric-coated high-buffered pancrelipase reduces steatorrhea in patients with cystic fibrosis: a prospective, randomized study. J Am Diet Assoc 106:1181-6 |
