CINCINNATI--(BUSINESS WIRE)--Symplmed announced today that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for investigational drug Prestalia®, the first single-pill, fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate for the treatment of hypertension in the U.S. Symplmed filed the application under section 505(b)(2) consistent with FDA’s guidance. The Prescription Drug User Fee Act (PDUFA) goal date for Prestalia is January 21, 2015.
Perindopril is a well-known, long-acting angiotensin-converting enzyme (ACE) inhibitor indicated for hypertension and stable coronary artery disease. Amlodipine, the number one prescribed anti-hypertensive, is a calcium channel blocker indicated for the treatment of hypertension and coronary artery disease. Servier, a leading French private pharmaceutical research company and development partner to Symplmed, currently markets a single-pill combination treatment as Coveram® in 84 countries outside the United States. Prestalia is the first and only single-pill, fixed-dose combination of these two important medicines to be reviewed by the FDA to date.
“Acceptance of our NDA is an important corporate milestone for Symplmed as Prestalia will be our first proprietary product with regulatory exclusivity,” said Erik Emerson, president and CEO of Symplmed. “Phase III data showed that Prestalia provided rapid and sustained blood pressure control in one convenient pill. We look forward to working with the FDA throughout the review process.”
The Prestalia NDA is primarily supported by data from the 837-patient Phase III PATH trial (Perindopril Amlodipine for the Treatment of Hypertension) which demonstrated that the single pill of perindopril arginine combined with amlodipine besylate was significantly better than either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after six weeks of treatment.
“The clinical outcomes from the Phase III PATH study suggest that Prestalia could offer an effective as well as convenient option for patients,” said George L. Bakris, MD, former president of the American Society of Hypertension and principal investigator for the PATH trial. “The clinical study also indicated that the combination may provide a better benefit/risk ratio than either treatment alone. A single-pill, fixed-dose combination of perindopril arginine and amlodipine besylate would be a welcome addition to our treatment options.”
DyrctAxess: The Next Step in Optimizing Care
If approved, Symplmed would offer Prestalia through its proprietary web portal, DyrctAxess, as part of a comprehensive hypertension-management offering. Symplmed is revolutionizing the process in which life-saving and health-promoting medications are obtained from its own growing pipeline, as well as from industry partners. DyrctAxess unifies all elements of the prescription process including claims adjudication, fulfillment, compliance and outcomes tracking. The portal offers enhanced efficiency, control and information to empower patients, physicians and payers and help achieve optimal care. For more information, visit www.dyrctaxess.com.
Founded in 1954, 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 140 countries, Servier employs more than 21,000 people worldwide. For more information, visit www.servier.com.
Symplmed is a new pharmaceutical company revolutionizing the delivery of life-saving and health-promoting medications, from its own growing product line and from industry partners, through the company’s proprietary DyrctAxess web portal. Symplmed is launching in high blood pressure (hypertension) with a proprietary ACE inhibitor ACEON® (perindopril erbumine tablets) and a fixed-dose combination (FDC) of perindopril/amlodipine that is currently under review by the FDA. The company also has development plans for DyrctAxess in six additional therapeutic areas. For more information, visit www.symplmed.com.
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.