FDA OKs Silvergate Pharmaceuticals’ Hypertension Drug

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Full prescribing information.

DENVER, CO--(Marketwired - August 13, 2013) -

Silvergate Pharmaceuticals Inc., focused on the development and commercialization of innovative and safe medicines for children, today announced that the United States 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 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.

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 < 30 mL/min/1.73 m(2), as no data are available.
• Epaned is contraindicated in patients who are hypersensitive to enalapril or any component of Epaned, and in patients with a history of hypersensitivity related to previous treatment with an ACE inhibitor.
• Epaned is contraindicated in patients with hereditary or idiopathic angioedema.
• Dual inhibition of the renin-angiotensin system (RAS): Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of renal impairment, hypotension and hyperkalemia.
• Do not co-administer aliskiren in patients with diabetes. Avoid use of aliskiren with Epaned in patients with renal impairment.
• Avoid potassium-sparing agents in patients with heart failure.
• In patients who are elderly, volume-depleted (as on diuretic therapy), or with compromised renal function, use of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including enalapril, may result in deterioration of renal function, including renal failure. Monitor renal function periodically in patients receiving enalapril and NSAID therapy.
• Epaned attenuates potassium loss caused by thiazide-type diuretics. Potassium-sparing diuretics, potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium.
• Monitor serum lithium levels frequently if lithium is concomitantly administered with Epaned.
• Nitritoid reactions have been reported rarely in patients with injectable gold (sodium aurothiomalate) and concomitant enalapril therapy.
• Head and neck angioedema: Angioedema of the face, extremities, lips, tongue, glottis, and/or larynx, including some fatal reactions, has been reported in patients treated with ACE inhibitors, including enalapril. Patients with a history of angioedema may be at increased risk of angioedema while receiving an ACE inhibitor.
• Intestinal angioedema has been reported in patients treated with ACE inhibitors.
• Anaphylactoid reactions during dialysis: Sudden and potentially life-threatening anaphylactoid reactions have occurred in some patients with high-flux membranes treated concomitantly with an ACE inhibitor.
• Hypotension: Epaned can cause symptomatic hypotension, sometimes complicated by oliguria, progressive azotemia, acute renal failure, or death. Patients at risk of excessive hypotension include those with the following conditions or characteristics: heart failure with systolic blood pressure below 100 mmHg, ischemic heart disease, cerebrovascular disease, hyponatremia, high-dose diuretic therapy, renal dialysis, or severe volume and/or salt depletion of any etiology. Symptomatic hypotension is also possible in patients with severe aortic stenosis or hypertrophic cardiomyopathy.
• Surgery/anesthesia: In patients undergoing major surgery or during anesthesia with agents that produce hypotension, Epaned may block angiotensin II formation secondary to compensatory renin release.
• Hepatic failure: Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death.
• Impaired renal function: Monitor renal function in patients treated with Epaned. Changes in renal function, including acute renal failure, can be caused by drugs that inhibit the renin-angiotensin system. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on Epaned.
• Hyperkalemia: Serum potassium should be monitored in patients receiving Epaned. Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics, potassium supplements, and/or potassium-containing salt substitutes.

To report SERIOUS ADVERSE EVENTS, contact Silvergate Pharmaceuticals at 1-855-379-0382, 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 WARNINGS.

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.

(1) http://www.pediatrichypertension.org/

(2) http://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.

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