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Aptalis Pharmaceutical Technologies (EURX) Announces FDA Approval of 25,000 Lipase-Unit Strength of ZENPEP(R)


7/15/2011 6:25:36 AM

BRIDGEWATER, NJ--(Marketwire - July 14, 2011) - 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 (http://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.

About ZENPEP®

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.

Important Prescribing Information

Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement. Exercise caution when doses of ZENPEP exceed 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day).

To avoid irritation of oral mucosa, do not chew ZENPEP or retain in the mouth.

Exercise caution when prescribing ZENPEP to patients with gout, renal impairment, or hyperuricemia.

There is theoretical risk of viral transmission with all pancreatic enzyme products, including ZENPEP.

Exercise caution when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.

The most common adverse events ( > 6% of patients treated with ZENPEP) are abdominal pain, flatulence, headache, cough, decreased weight, early satiety, and contusion.

The safety and effectiveness of ZENPEP were assessed in pediatric patients, ages 1 to 17 years. The safety and efficacy of pancreatic enzyme products with different formulations of pancrelipase in pediatric patients have been described in the medical literature and through clinical experience.

For complete information about safety, warnings and precautions for ZENPEP, please see full Prescribing Information and Medication Guide at www.zenpep.com.

About Aptalis

Aptalis Pharma Inc. is a privately held, leading specialty pharmaceutical company providing innovative, effective therapies for unmet medical needs including cystic fibrosis and gastrointestinal disorders. Aptalis, formed from the recent combination of Axcan Pharma and Eurand, has manufacturing and commercial operations in the United States, the European Union and Canada, and its products include ZENPEP®, CANASA®, CARAFATE®, PYLERA®, LACTEOL®, DELURSAN®, PANZYTRAT® and SALOFALK®. Aptalis also formulates and clinically develops enhanced pharmaceutical and biopharmaceutical products for itself and others using its proprietary technology platforms including bioavailability enhancement of poorly soluble drugs, custom release profiles, and taste-masking/orally disintegrating tablet (ODT) formulations. For more information, visit www.aptalispharma.com.


Contact:

Steve Gannon
Aptalis Pharma
+1-450-467-5138
Email Contact


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