Symplmed Announces FDA Approval of Prestalia® for Treatment of Hypertension

Published: Jan 26, 2015

CINCINNATI & BEND, Ore.--(BUSINESS WIRE)-- Symplmed Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Prestalia® (perindopril arginine and amlodipine) tablets, licensed from Servier (Suresnes, France), for the treatment of hypertension. Prestalia, the first fixed-dose combination of these two medications, may be used in patients whose blood pressure is not adequately controlled on monotherapy. Prestalia may be used as initial therapy if a patient is likely to need multiple drugs to achieve their blood pressure goals.

“This is a significant milestone for Symplmed and for our development partner Servier as it is the first product from our perindopril pipeline to receive FDA approval,” said Erik Emerson, President and CEO of Symplmed Pharmaceuticals. “With ACE inhibitors and calcium channel blockers being two of the most highly prescribed products for the treatment of cardiovascular disease, we are excited to be able to provide physicians and patients these two therapeutic classes in a single pill combination right from the start of the treatment for hypertension.”

“The burden of hypertension remains very high in all countries and the combination therapy is often the only treatment option for many patients,” said Dr. Isabelle Tupinon-Mathieu, Vice President R&D, Head of the Center for Therapeutic Innovation in Cardiology at Servier. “This new combination of perindopril arginine with amlodipine besylate will definitely contribute to help these patients.”

FDA approval of Prestalia was based on data from the 837-patient Phase III PATH trial (Perindopril Amlodipine for the Treatment of Hypertension). The study demonstrated that the fixed-dose combination of perindopril arginine with amlodipine besylate in a single pill was significantly better than either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after six weeks of treatment. It also suggested that the combination may provide a better benefit/risk ratio than either treatment alone. There are additional clinical studies that demonstrate use of these classes of drugs together may reduce cardiovascular events.

“We now have another great combination of two drugs each with an evidence based outcome history that are combined in a single pill,” said George Bakris, MD, former president of the American Society of Hypertension and principal investigator for the PATH trial.

Symplmed plans to make Prestalia available to physicians and patients within the first quarter of 2015 through its hypertension management program, bpCareConnect. Powered by Symplmed’s DyrctAxess™ technology, bpCareConnect is a patient membership program that caps blood pressure medication costs, provides monitoring devices, offers online tracking tools and ships directly to the patient. To enroll in bpCareConnect, visit www.bpcareconnect.com.

For more information or to register for updates on availability of Prestalia, visit www.prestalia-us.com.

About Prestalia

Prestalia contains perindopril arginine, an angiotensin converting enzyme inhibitor, and amlodipine, a dihydropyridine calcium channel blocker, and is indicated for the treatment of hypertension, to lower blood pressure. Prestalia may be used in patients whose blood pressure is not adequately controlled on monotherapy. Prestalia may be used as initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine and the ACE inhibitor class to which perindopril principally belongs. There are no controlled trials demonstrating risk reduction with Prestalia.

Patients with moderate-to-severe hypertension are at a relatively high risk of cardiovascular events (e.g., stroke, heart attack, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. Consider the patient’s baseline blood pressure, target goal and the incremental likelihood of achieving the goal with a combination product, such as Prestalia, versus a monotherapy product when deciding upon initial therapy. Individual blood pressure goals may vary based on the patient’s risk.

Prestalia tablets are contraindicated in patients with hereditary or idiopathic angioedema, with or without previous ACE inhibitor treatment, and in patients who are hypersensitive to perindopril, to any other ACE inhibitor, or to amlodipine. Do not co-administer aliskiren with ACE inhibitors, including Prestalia, in patients with diabetes.

Important Safety Information for Prestalia

WARNING: FETAL TOXICITY

When pregnancy is detected, discontinue Prestalia as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury to or death of the developing fetus.

About Symplmed

Symplmed Pharmaceuticals is a private pharmaceutical company optimizing the value of its medicines and those of its industry partners by streamlining the prescription process, from fulfillment and payment to therapeutic compliance and outcomes monitoring. The Company’s patented technology platform, DyrctAxess™, enables direct delivery of medications to a patient’s home and addresses the problem of unfilled prescriptions. Symplmed is taking a therapeutic area approach, ensuring that medications necessary to manage a particular disease state are available through its DyrctAxess platform. The Company’s initial focus is high blood pressure (hypertension) with a proprietary ACE inhibitor ACEON® (perindopril erbumine) and Prestalia®, a single-pill, fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate. Symplmed also plans to expand its pipeline in multiple therapeutic areas. For more information, visit www.symplmed.com.

About Servier

Servier is an independent French pharmaceutical research company. Its development is based on the continuous pursuit of innovation in the therapeutic areas of cardiovascular, metabolic, neurologic, psychiatric, bone and joint diseases as well as cancer. With a strong international presence in 146 countries, Servier employs more than 21,400 people worldwide. More information is available at www.servier.com.

Forward-Looking Statement

All of the statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, are forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown. Some examples of known risks are: the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which Symplmed does business, fluctuations in costs, and changes to the competitive environment due to consolidation or otherwise. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements.

Media:

Sam Brown, Inc.
Mariesa Kemble, 608-850-4745
mariesakemble@sambrown.com

or

Servier Communication Department, +33 1 5572 6037
presse@servier.fr

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