Results Published In Journal of Cystic Fibrosis Confirm Creon (pancrelipase) Delayed-Release Capsules Improves Fat Absorption in Patients With Cystic Fibrosis
- Data Support Safe and Effective Use of CREON(R) to Meet Critical Medical Need for CF Patients -
MARIETTA, Ga., Oct. 9 /PRNewswire/ -- Solvay Pharmaceuticals,
Inc. announced today that Phase III data published in the Journal
of Cystic Fibrosis showed that CREON® (pancrelipase)
Delayed-Release Capsules, the most prescribed pancreatic enzyme
replacement therapy (PERT) in the United States, significantly
improves a key measure of fat absorption in patients with CF who
suffer from exocrine pancreatic insufficiency (EPI). EPI is a
condition resulting from a deficiency in the production and/or
secretion of pancreatic enzymes that are necessary to digest
nutrients in food and, if untreated, can lead to poor growth, poor
weight gain and failure to thrive in children with CF.
According to the study results, patients with CF and confirmed
EPI had an improved coefficient of fat absorption (CFA) during
treatment with CREON® compared to treatment with placebo. CFA
is calculated based on measures of fat ingestion and fat excretion;
assessing the CFA of a patient is a way to measure the absorption
of fat as a percentage of fat intake in patients being tested for
EPI. The trial reached statistical significance on its primary
endpoint, which was CFA.
"These study results demonstrate that CREON® is effective in
decreasing the maldigestion and malabsorption associated with
pancreatic insufficiency in patients with cystic fibrosis," said
Bruce C. Trapnell, MD, Professor of Medicine and Pediatrics at the
University of Cincinnati and Cincinnati Children's Hospital Medical
Center. "Patients enrolled in this study had poor fat absorption
without treatment, which is commonly associated with uncomfortable
gastrointestinal symptoms and severe malnutrition. In addition to
the impressive increase in fat absorption demonstrated in these
individuals, the secondary outcomes of the study have important
implications for those involved in the care of these
patients."
CREON® was approved by the Food and Drug Administration
(FDA) with an indication to treat EPI due to CF or other conditions
based on the results of this clinical study. As the first
FDA-approved PERT, CREON® was also the first product in the
class to provide a Medication Guide with important dosing
information, including instructions for administration to infants
and toddlers, which is consistent with the CF Foundation Consensus
Conference Guidelines.
Study Details
The double-blind, randomized, placebo-controlled two-arm, crossover study examined the efficacy and safety of CREON® (Pancrelipase) Delayed-Release 24,000 lipase unit capsules in subjects aged 12 years or older with EPI due to CF. EPI was confirmed in all subjects by a CFA of <70% without pancreatic enzyme supplementation or fecal elastase <50 micrograms>
About Exocrine Pancreatic Insufficiency and Pancreatic Enzyme
Replacement Therapy
Exocrine pancreatic insufficiency (EPI) is a condition resulting
from a deficiency in the production and/or secretion of pancreatic
enzymes that are necessary to digest nutrients in food. The safety
and efficacy of prior formulations of pancrelipase in pediatric
patients with EPI due to CF have been described in the medical
literature. Prior formulations of pancrelipase have also
demonstrated clinical efficacy in those patients through years of
clinical experience. PERTs work in patients with EPI by delivering
pancreatic enzymes to the small intestine to help break down fats,
proteins and carbohydrates in food, thereby acting as a replacement
for digestive enzymes physiologically secreted by the pancreas. EPI
can occur as a complication of a variety of diseases or conditions,
including CF, pancreatic cancer, gastrointestinal surgery and
chronic pancreatitis. Statistics show that more than 80% of CF
patients have EPI, which usually develops during the first year of
life.
The original products in the pancreatic enzyme drug class
pre-date modern FDA regulatory requirements. Over the past two
decades, products in this class have been allowed to be marketed as
prescription drugs without formal NDA approval. In 2004, the FDA
required manufacturers to submit New Drug Applications (NDAs) for
all pancreatic enzyme replacement therapies in order to remain on
the market. By April 2010, all pancreatic enzyme replacement
therapies are required to have approved NDAs and must be
manufactured under the new guidelines.
Important Safety Information about FDA-Approved CREON®
Warnings and precautions include fibrosing colonopathy, a rare,
serious adverse reaction that has been described in association
with high-dose use of pancreatic enzyme replacement therapy in the
treatment of cystic fibrosis patients. Caution should be exercised
when doses of CREON® exceed 2,500 lipase units/kg of body
weight per meal (or greater than 10,000 lipase units/kg of body
weight per day). Care should be taken to ensure that CREON® is
not chewed or retained in the mouth to avoid irritation of oral
mucosa. Caution should be exercised when prescribing CREON® to
patients with gout, renal impairment, or hyperuricemia. There is
theoretical risk of viral transmission with all pancreatic enzyme
products, including CREON®. Caution should be exercised when
administering pancrelipase to a patient with a known allergy to
proteins of porcine origin.
In the clinical study used to demonstrate the efficacy and
safety of FDA-approved CREON®, the incidence of adverse events
(regardless of causality) was higher during placebo treatment (71%)
than during CREON® treatment (50%). Treatment-emergent adverse
events occurring in at least two patients (greater than or equal to
6%) receiving CREON® or placebo were abdominal pain, abdominal
pain upper, abnormal feces, cough, dizziness, flatulence, headache,
and weight decreased.
CREON® 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 applicable to this class of
products, including CREON®, is provided for patients and
caregivers, with an emphasis on understanding the risk of fibrosing
colonopathy as well as the importance of not over- or under-dosing.
The FDA requires that the Medication Guide be handed out with every
prescription for the drug dispensed.
For full safety and Prescribing Information about the
FDA-approved formulation of CREON®, visit www.CREON.com.
Solvay Pharmaceuticals, Inc., of Marietta, Georgia, is the U.S.
subsidiary of Solvay Pharmaceuticals. For more information, visit
www.solvaypharmaceuticals-us.com.
Solvay Pharmaceuticals is a research driven group of companies
that constitutes the global pharmaceutical business of the Solvay
Group. These companies seek to fulfill carefully selected, unmet
medical needs in the therapeutic areas of neuroscience,
cardiometabolic, influenza vaccines, gastroenterology and men's and
women's health. Its 2008 sales were EUR 2.7 billion and it employs
more than 9,000 people worldwide. For more information, visit
www.solvaypharmaceuticals.com.
Solvay is an international Chemicals and Pharmaceuticals Group
with headquarters in Brussels. It employs some 28,300 people in 50
countries. In 2008, its sales amounted to EUR 9.5 billion generated
by its three activity sectors: Chemicals, Plastics and
Pharmaceuticals. Solvay (NYSE-Euronext: SOLB.BE - Bloomberg:
SOLB.BB - Reuters: SOLBt.BR) is listed on NYSE-Euronext at
Brussels. Details are available at www.solvay.com.
CONTACT: Jessica Riley Aaron Estrada Solvay Pharmaceuticals, Inc. Ruder Finn (770) 578-5637 (212) 715-1568 jessica.riley@solvay.com estradaa@ruderfinn.com
Source: Solvay Pharmaceuticals, Inc.
CONTACT: Jessica Riley, Solvay Pharmaceuticals, Inc.,
+1-770-578-5637,
jessica.riley@solvay.com; or
Aaron Estrada, Ruder Finn, +1-212-715-1568,
estradaa@ruderfinn.com
Web Site: http://www.solvaypharmaceuticals.com/
Posted: October 2009
