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SOURCE Silvergate Pharmaceuticals, Inc.
DENVER, Nov. 4, 2013 /PRNewswire/ -- Silvergate Pharmaceuticals, Inc., focused on the development and commercialization of innovative and safe medicines for children, today announced the availability by prescription of Epaned™ (enalapril maleate Powder for Oral Solution) to treat hypertension (high blood pressure) in people older than one month. Enalapril is one of the most commonly prescribed medicines in the United States to treat high blood pressure.
Approved by the FDA in August 2013, Epaned is specially formulated as a flavored liquid solution to appeal to children and people who have difficulty swallowing enalapril tablets. Many medicines are tested and developed for adults, leaving doctors and pharmacies to adjust adult doses for pediatric use. Approximately half of the prescription drugs commonly given to children do not have information on appropriate pediatric doses on their labels.1 Epaned is a powder form of enalapril that a pharmacist will use to make an oral solution so that children will no longer have to rely on adult tablets being made into a suspension.
"We're pleased to launch Epaned so quickly after receiving FDA approval," said Frank Segrave, President & CEO, Silvergate Pharmaceuticals, Inc. "Silvergate is happy to take the lead in developing FDA-approved medicines for children – an area of drug development that is often overlooked."
Epaned is available through an extensive network of pharmacies and may be eligible for reimbursement by most private insurance plans and state Medicaid programs. For additional information on how to obtain Epaned, please call 1-855-379-0382 or visit www.SilvergatePharma.com.
Epaned (enalapril maleate Powder for Oral Solution) is an FDA-approved powder form of enalapril maleate indicated for the treatment of hypertension (high blood pressure) in adults and children older than one month, to lower blood pressure. Enalapril is one of the most commonly prescribed drugs in the United States to treat high blood pressure.
Epaned is an oral solution formulation that has a taste that appeals to children, which may help to ensure compliance. People who have trouble swallowing enalapril tablets may also benefit from Epaned.
Enalapril is indicated for the treatment of high blood pressure in children over one month and adults. It works by blocking a natural chemical in the body that causes blood vessels to narrow. As a result, the blood vessels relax. This lowers blood pressure and increases the supply of blood and oxygen to the heart.
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Control of high blood pressure should be part of a comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.
About Pediatric Hypertension
According to the International Pediatric Hypertension Association:2
Childhood obesity rates in the US have tripled in the last 30 years. Recent statistics show that nearly 1 in 3 children are overweight or obese. In addition, approximately 10 percent of infants and toddlers (birth to two years of age) have higher than normal weight based on their length.3,4 Children and adolescents should have their blood pressure measured at least once per year.
About Silvergate Pharmaceuticals, Inc.
Headquartered near Denver, Colorado, Silvergate Pharmaceuticals, Inc. is a privately held pharmaceutical company dedicated to leading the way in the development and commercialization of innovative pediatric medications.
Silvergate Pharmaceuticals, Inc. is dedicated to filling the unmet needs of children, developing innovative medications that will help improve the quality of care and outcomes for pediatric patients. For additional information, please visit www.SilvergatePharma.com.
Epaned™ (enalapril maleate Powder for Oral Solution) is an angiotensin-converting enzyme (ACE) inhibitor indicated for treatment of hypertension in adults and children older than one month, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.
ADDITIONAL IMPORTANT SAFETY INFORMATION
To report SUSPECTED ADVERSE EVENTS, contact Silvergate Pharmaceuticals, Inc. at 1-855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
Please see accompanying full PRESCRIBING INFORMATION for additional important safety information, including BOXED WARNING.
1 Sachs AN, Avant D, Lee CS, Rodriguez W, Murphy MD. Pediatric Information in Drug Product Labeling. JAMA. 2012;307(18):1914-1915.
3 Barnes M, Chair, Task Force on Childhood Obesity, and Director, Domestic Policy Council. Solving the problem of childhood obesity within a generation. White House Task Force on Childhood Obesity Report to the President. 2010. Available at: http://www.letsmove.gov/sites/letsmove.gov/files/TaskForce_on_Childhood_Obesity_May2010_FullReport.pdf
4 Ogden CL, et al. Prevalence of obesity and trends in body mass index among US children and adolescents, 1999-2010. JAMA. 2012;307:483-490.
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