“These findings may suggest the potential for reducing pill burden for patients with EPI due to CF,” said Ruth Thieroff-Ekerdt, M.D., Chief Medical Officer, Eurand Pharmaceuticals. “Patients can expect ZENPEP to provide control of signs and symptoms as early as day 2 of treatment, regardless of their concomitant medication with gastric acid modifiers. H2 antagonists and PPIs are frequently taken concomitantly with PEPs to improve their efficacy.”
In a Phase III randomized, double-blind, placebo-controlled study of 34 patients with EPI due to CF, ZENPEP resulted in significantly higher coefficient of fat absorption (a key indicator of nutrient absorption in patients with CF) compared to placebo. Enrolled patients discontinued PPIs/H2 antagonists and were switched from previous PEPs to ZENPEP during a dose-titration and stabilization period according to symptom control of EPI for six to nine days prior to randomization (ZENPEP or placebo). In a post-hoc analysis, a total symptom score index (TSI) was calculated from patient-reported signs and symptoms of stool consistency, bloating, flatulence, pain, and visible oil in stool.
At comparable doses, patients experienced significant and rapid symptom improvement during the stabilization period when switched from previous PEPs (mean dose 5,100 U lipase/kg/day) to ZENPEP (mean dose 4,600 U lipase/kg/day). Symptom improvement, as measured by the TSI, was observed as early as day 2 and was significant at day 4 (P=0.017). There were no significant differences in TSI scores between patients previously exposed to PPIs/H2 antagonists and those who were not previously exposed to PPIs/H2 antagonists. ZENPEP was well tolerated in all treatment periods, including the stabilization period, and its safety profile was consistent with those of other PEPs.
ZENPEP has been evaluated in clinical studies in adults and children as young as one year old. ZENPEP is offered in four dosage strengths — 5,000, 10,000, 15,000 and 20,000 units of lipase — to allow for precise dosing and for potentially reduced pill burden, and to meet the varied needs of infants, toddlers, adolescents and adults with EPI. In addition, the contents of ZENPEP capsules may be opened and sprinkled on soft acidic foods such as apple sauce. This convenient option is a key attribute to address the needs of patients who may have difficulty swallowing capsules, such as very young patients or certain older patients.
About Exocrine Pancreatic Insufficiency (EPI)
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.
Important Safety Information
ZENPEP has been approved with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh its risks. As part of the REMS, a Medication Guide with important dosing and safety information about ZENPEP will be handed out with each new prescription and refill.
The REMS and Medication Guide address the risk associated with the use of ZENPEP, including fibrosing colonopathy, a rare, serious adverse reaction that has been reported following treatment with high-dose use of pancreatic enzyme replacement therapy in the treatment of cystic fibrosis patients. The total daily dose of ZENPEP should not exceed 10,000 lipase units/kg of body weight/day, and caution should be used with doses exceeding 2,500 lipase units/kg of body weight per meal. Also, there is a theoretical risk of transmission of viral disease, since ZENPEP, as other porcine-derived pancreatic enzymes, is sourced from pancreatic tissue from swine used for food consumption. No cases of transmission of an infectious illness associated with the use of porcine pancreatic extracts have been reported.
Care should be taken to ensure that ZENPEP is not chewed or retained in the mouth to avoid irritation of oral mucosa and/or loss of enzyme activity, and the capsules or beads should be swallowed immediately with adequate amounts of liquid. Caution should be exercised when using ZENPEP in patients with gout, renal impairment, or hyperuricemia; porcine-derived pancreatic enzyme products may increase blood uric acid levels. Caution should be exercised for patients with known allergies to proteins of porcine origin. In rare instances, severe allergic reactions including anaphylaxis, asthma, hives, and pruritus have been reported with other pancreatic enzyme products with different formulations of the same active ingredient, pancrelipase, as that of ZENPEP.
In clinical trials assessing the short-term safety of ZENPEP, the incidence of adverse events (regardless of causality) was similar during double-blind ZENPEP treatment and placebo treatment. The most commonly reported adverse events occurring in at least two patients (greater than or equal to 6% of patients) included: abdominal pain, flatulence, headache, cough, decreased weight, early satiety, and contusion. The type and incidence of adverse events were similar in children and adults.
For complete information about safety, warnings and precautions for ZENPEP, please see full Prescribing Information and Medication Guide at www.zenpep.com.
Eurand is a specialty pharmaceutical company that develops, manufactures and commercializes enhanced pharmaceutical and biopharmaceutical products based on its proprietary pharmaceutical technologies. Eurand has had six products approved by the FDA since 2001 and has a pipeline of product candidates in development for itself and its collaboration partners. Its technology platforms include bioavailability enhancement of poorly soluble drugs, custom release profiles and taste-masking orally disintegrating tablet (ODT) formulations. Eurand is a global company with facilities in the U.S. and Europe. For more information, visit www.eurand.com.