FDA Approves 25,000 Lipase-Unit Strength of ZENPEP®

Aptalis Pharma, a global specialty pharmaceutical company focused on gastrointestinal diseases and cystic fibrosis (CF), today announced that the U.S. Food and Drug Administration (FDA) has approved a new strength of ZENPEP® (pancrelipase) Delayed-Release Capsules.

The new formulation will be offered in 25,000 units of lipase, the highest strength currently approved by the FDA. The 25,000-unit strength will give physicians yet another option in dosing patients with exocrine pancreatic insufficiency (EPI) caused by CF or other conditions, and could potentially reduce pill burden.

“Added to the recent FDA approval of the 3,000-unit dose, ZENPEP offers physicians and their patients the broadest range of dosing options, including the lowest and highest doses available, of any FDA-approved pancreatic enzyme product,” said Frank Verwiel, M.D., President and Chief Executive Officer, Aptalis Pharma. He noted that ZENPEP is the only pancreatic enzyme offered in six dosage strengths — 3,000, 5,000, 10,000, 15,000, 20,000 and 25,000 units of lipase — reflecting the company’s strong emphasis on research and development. “We believe the broad range of ZENPEP strengths can provide added convenience by helping patients reduce the number of capsules they take with every meal, while the precise dosing can aid in the management of their EPI.”

Verwiel noted that offering six even strengths of ZENPEP also reflects the Company’s commitment to patients with EPI. For patients with cystic fibrosis in particular, the Company also provides award-winning patient-support programs such as ZPoints (www.zenpep.com/site/cfpatient.aspx) and CareFirst for Life (www.carefirstforlife.com). The ZPoints program, which provides vitamins, supplements and other support for patients with CF, will be extended to include this new dosage strength as well as the recently approved 3,000-unit strength.

About Exocrine Pancreatic Insufficiency

Exocrine Pancreatic Insufficiency (EPI) is the inability to properly digest food due to a lack of digestive enzymes made by the pancreas. EPI can result from a number of diseases, including cystic fibrosis, pancreatic cancer, gastrointestinal surgery, and chronic pancreatitis. The FDA estimates that more than 200,000 Americans suffer from EPI. If left untreated, EPI causes malnutrition and, especially in CF patients, impaired growth in children, compromised immune response and shortened life expectancy.


Aptalis manufactures and markets ZENPEP® (pancrelipase) Delayed-Release Capsules, an FDA-approved pancreatic enzyme product (PEP) indicated for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions. This condition affects approximately 90% of patients with CF. ZENPEP is currently marketed only in the U.S.

Source: Aptalis Pharma news release