Aptalis Pharma Studies Panzytrat in Cystic Fibrosis Patients in Phase 4 Trial

Aptalis Pharma continued to evaluate its pancreatic enzyme products (PEPs) in patients with cystic fibrosis and exocrine pancreatic insufficiency in its Phase 4 clinical trial of Panzytrat® 25,000. Results show that patients taking Panzytrat had better control over their steatorrhea, or fecal fat content.

The study was designed to evaluate cystic fibrosis patients with exocrine pancreatic insufficiency while taking Aptalis’ Panzytrat 25,000 or Abbott’s Kreon® 25,000. Notably, Kreon (also Creon) was one of the first PEPs approved by the FDA, and in 2009, Solvay Pharmaceuticals (now Abbott) established the efficacy and safety of Creon 24,000 in cystic fibrosis patients with exocrine pancreatic insufficiency.

Two treatment periods were involved: a 14-day treatment with either Panzytrat or Kreon and a 14-day treatment with the opposite intervention (Kreon or Panzytrat). In total, 81 of the original 87 enrolled patients completed the trial, and withdrawals were due to adverse events.

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Analysis of the primary outcome measure, coefficient of fat absorption, showed no difference between treating patients with Panzytrat or Kreon. Coefficients were 78.27% and 80.35%, respectively (p=0.4590). Secondary measures, which included daily number of stools, percentage of normal stools, and frequency of abdominal symptoms, showed similar results between treatments. Although no statistical analyses were conducted to confirm a difference, more patients treated with Panzytrat experienced adverse effects (32 versus 20 treated with Kreon).

Panzytrat 25,000 capsules are porcine-derived preparations of pancrelipase and contain lipase, protease, and protease. Cystic fibrosis patients with exocrine pancreatic insufficiency are benefited by PEPs such as Panzytrat because patients are deficient in the enzymes required for digestion of fats, carbohydrates, and proteins. Panzytrat 25,000 is specially formulated to avoid inactivation by stomach acids and intestinal pH. It is only indicated for use in patients 18 months and older.