FDA Approves 2 New Indications for Epaned®, the First and Only Enalapril Powder for Oral Solution

DENVER, Sept. 8, 2014 /PRNewswire/ -- Silvergate Pharmaceuticals, Inc. (www.Silvergatepharma.com), 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) for the treatment of symptomatic heart failure and the treatment of asymptomatic left ventricular dysfunction (to decrease the rate of development of overt heart failure and to reduce hospitalization for heart failure). These indications are in addition to the prior approval for hypertension (high blood pressure) in patients older than 1 month.¹

"Now with 3 indications, Epaned is available to help more patients who need the proven benefits of enalapril in an FDA-approved powder for oral solution, thereby ensuring that they are receiving a medicine that meets the highest quality standards," said Frank Segrave, President & CEO, Silvergate Pharmaceuticals, Inc.

Epaned delivers trusted efficacy. The effectiveness of enalapril has been well established in clinical trials.¹ With its unique formulation, Epaned provides a consistent potency in each dose.¹ Epaned also offers the quality of a product made in accordance with FDA regulations and requirements.

Silvergate is committed to helping patients and caregivers by making sure that Epaned is affordable and accessible to all patients. Epaned is widely available at patients' local pharmacies and is covered by the vast majority of commercial payers. Epaned is also reimbursed by Medicaid in every state. Co-pay support and patient assistance are available for qualifying patients.

For additional information on how to obtain Epaned, please call 1-855-379-0382 or visit Epaned.com.

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.

INDICATION
EPANED is an angiotensin-converting enzyme (ACE) inhibitor indicated for:

• treatment of hypertension in adults and children older than 1 month, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
• treatment of symptomatic heart failure.
• treatment of asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure.

ADDITIONAL IMPORTANT SAFETY INFORMATION

• Epaned is contraindicated in patients who are hypersensitive to enalapril or any component of Epaned.
• Epaned is contraindicated 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.
• Do not co-administer aliskiren with Epaned in patients with diabetes.
• Head and Neck Angioedema: Angioedema of the face, extremities, lips, tongue, glottis, and/or larynx, including some fatal reactions, have been reported in patients treated with ACE inhibitors, including Epaned, at any time during treatment. Epaned should be promptly discontinued and appropriate therapy and monitoring provided until complete and sustained resolution of signs and symptoms of angioedema has occurred. Patients with a history of angioedema may be at increased risk of angioedema while receiving an ACE inhibitor.
• Anaphylactoid Reactions during Dialysis: Sudden and potentially life-threatening anaphylactoid reactions have occurred in some patients dialyzed with high-flux membranes treated concomitantly with an ACE inhibitor. In such patients, dialysis must be stopped immediately, and aggressive therapy for anaphylactoid reactions must be initiated. In these patients, consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption.
• Intestinal Angioedema has been reported in patients treated with ACE inhibitors.
• 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. These patients should be started under close medical supervision and closely followed for the first 2 weeks of treatment with Epaned and whenever the dose of Epaned and/or a diuretic is increased. 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. Patients who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up.
• 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.
• Adverse Reactions (where rate on enalapril exceeds the rate on placebo by at least 0.2%) occurring in greater than 1% of patients with hypertension treated with enalapril in controlled trials include: fatigue, orthostatic effects, asthenia, cough, and rash. Adverse reactions reported in clinical trials of heart failure were similar to those seen in clinical trials for hypertension. In patients treated for heart failure, there was an increased incidence of hypotension and dizziness.
  See full Prescribing Information for other Adverse Reactions.
• 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.
• 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 hypotension, hyperkalemia and changes in renal function, (including acute renal failure) compared to monotherapy. Closely monitor BP, renal function and electrolytes.
• Avoid use of aliskiren with Epaned in patients with renal impairment.
• 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.
• Lithium toxicity has been reported in patients receiving enalapril and lithium concomitantly. 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.
• Epaned is not recommended in neonates and in pediatric patients with glomerular filtration rate < 30 mL/min/1.73 m².

View full Prescribing Information for additional important Safety Information, including BOXED WARNING.

To report SERIOUS ADVERSE EVENTS, contact Silvergate Pharmaceuticals at 1-855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/Safety/MedWatch.

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.

Reference: Epaned [prescribing information]. Greenwood Village, CO: Silvergate Pharmaceuticals, Inc.; 2014.

Contact:
Jamie Hermann
1-720-398-5984
[email protected]

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SOURCE Silvergate Pharmaceuticals, Inc.