There is no evidence to suggest that the bioactivity or bioavailability of COTAZYM® would differ markedly in pediatric or geriatric patients from other patient populations.

CLINICAL STUDIES

Cystic Fibrosis

In a single center, unblinded, non-randomized, active-controlled, one sequence, 2-period (with no washout period) crossover Canadian study of 15 patients, under the age of 4 years, with exocrine pancreatic insufficiency secondary to cystic fibrosis, COTAZYM® (pancrelipase capsules, USP) was compared to another pancreatic enzyme preparation for the treatment of fat malabsorption. ³

COTAZYM® significantly reduced fecal fat as a percentage of intake when compared to baseline as follows:

In a single center, randomized, double-blind, placebo controlled, 2-period crossover, 5-day treatment U.S. study in 10 male patients, ages 10-16 years, with exocrine pancreatic insufficiency secondary to cystic fibrosis, COTAZYM® and other pancreatic enzyme preparation were compared to placebo for treatment of fat malasbsorption. ⁴

COTAZYM® significantly reduced fecal fat as compared to placebo as follows:

Chronic Pancreatitis

In a multicenter, randomized, unblinded, 3-period crossover, 6-day treatment U.S. study in 6 male patients, ages 43-58 years, with exocrine pancreatic insufficiency from chronic alcoholic pancreatitis, COTAZYM® (pancrelipase capsules, USP) and two other pancreatic enzyme preparations were compared to a no treatment control for the treatment of fat malabsorption. ¹

COTAZYM® significantly reduced fecal fat as compared to the no treatment control as follows:

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