New formulation: FDA approved pancrelipase delayed-release capsules (Pertyze, Digestive Care, Inc.) for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions.
On May 18, 2012, FDA approved pancrelipase delayed-release capsules (Pertzye, Digestive Care, Inc.) for the treatment of exocrine pancreatic insufficiency (EPI ) due to cystic fibrosis or other conditions. Pertzye, which is a combination of porcine-derived lipases, proteases, and amylases, is the sixth pancrelipase product to be approved by FDA. It is not interchangeable with other pancrelipase products.
Efficacy. The short-term efficacy of pancrelipase delayed-release capsules was evaluated in a randomized, double-blind, placebo-controlled, crossover study of 24 patients with EPI due to cystic fibrosis. Subjects received an individually titrated dose of pancrelipase delayed-release capsules (≤2,500 lipase units/kg/meal) or matching placebo for 6 to 8 days of treatment, followed by crossover to the alternate treatment for an additional 6 to 8 days. The mean coefficient of fat absorption was 83% with pancrelipase delayed-release capsules compared to 46% with placebo (difference of 36%, 95% CI, 28%–45%; P<.001). The mean change in coefficient of nitrogen absorption also favored pancrelipase delayed-release capsules as compared to placebo (difference of 32%; P<.05).
Safety. The short-term safety of pancrelipase delayed-release capsules was assessed in the same crossover study. The most common adverse reactions (occurring in ≥10% of subjects) observed in the clinical trial were diarrhea, dyspepsia, and cough. Delayed- and immediate-release pancreatic enzyme products with the same active ingredient (pancrelipase) have been used for the treatment of patients with EPI due to cystic fibrosis and other conditions. Prior longer-term safety concerns seen with these products include: fibrosing colonopathy (a rare adverse event most commonly seen in children or when administering >2,500 lipase units/kg/meal (or >10,000 lipase units/kg/day) and hyperuricemia (due to the purines found in porcine-derived pancreatic enzyme products).