FDA Approves Epaned, a Liquid Form of Enalapril for Children and Adults

Silvergate Pharmaceuticals Inc. (www.SilvergatePharma.com), focused on the development and commercialization of innovative and safe medicines for children, announced that the U.S. Food and Drug Administration (FDA) approved Epaned™ (enalapril maleate Powder for Oral Solution) to treat hypertension (high blood pressure) in people one month and older. Enalapril is one of the most commonly prescribed medicines in the United States to treat high blood pressure. "We're pleased to offer FDA-approved Epaned for people with high blood pressure, especially the small but significant group of pediatric patients who are affected by this disease," said Frank Segrave, President & CEO, Silvergate Pharmaceuticals Inc. "In developing Epaned, we were focused on what would most benefit children, such as great tasting flavor, ease of administration and consistent dosing. However, anyone who has difficulty swallowing enalapril tablets may respond well to Epaned." Epaned enables accurate dosing for children who until now have relied on an adjusted adult dose. Epaned is available through an extensive network of pharmacies and a qualified mail order service. Epaned will be reimbursed by most private insurance plans and state Medicaid programs. For additional information on how to obtain Epaned, please call 1-855-379-0382. About Epaned Epaned (enalapril maleate Powder for Oral Solution) is an FDA-approved form of enalapril maleate indicated for hypertension (high blood pressure) in people one month and older. 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 enables accurate dosing and 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 used to treat high blood pressure in children 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. Epaned reduces blood pressure. 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:[1],[2] • The effects of high blood pressure can begin during childhood. Mild to moderate high blood pressure is most commonly asymptomatic but may be associated with subtle changes in behavior or school performance. • Children with high blood pressure are more likely to have a definable cause for high blood pressure (such as kidney disease) than adults. • Children with high blood pressure also tend to have other medical problems, such as obesity, high blood lipids and/or diabetes mellitus. • In addition, children with high blood pressure tend to have high blood pressure as adults. Childhood obesity rates in the U.S. 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. Indication 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. • When pregnancy is detected, discontinue Epaned as soon as possible. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ADDITIONAL IMPORTANT SAFETY INFORMATION • Epaned is not recommended in neonates and in pediatric patients with glomerular filtration rate Please see accompanying full PRESCRIBING INFORMATION for additional important safety information, including Boxed WARNINGS. https://www.ereleases.com/pic/Epaned-PI.pdf 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 that offer greater dosing accuracy, safety and availability. Silvergate Pharmaceuticals 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 more information please visit www.SilvergatePharma.com. [1] https://www.pediatrichypertension.org/ [2] https://www.pediatrichypertension.org/faq.asp [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. [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.