Prestalia, which is the first single-pill, fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate, is indicated for the treatment of hypertension in the U.S.
Perindopril is a long-acting angiotensin-converting enzyme (ACE) inhibitor indicated for hypertension and stable coronary artery disease while Amlodipine is a calcium channel blocker indicated for the treatment of hypertension and coronary artery disease.
Prestalia is the first and only single-pill, fixed-dose combination of these two important medicines to be reviewed by the FDA to date, according to the company.
French pharmaceutical research company Servier is a development partner to Symplmed and currently markets a single-pill combination treatment as Coveram in 84 countries outside the U.S.
Symplmed president and CEO Erik Emerson said acceptance of the NDA is an important corporate milestone for Symplmed as Prestalia will be the company’s first proprietary product with regulatory exclusivity.
"Phase III data showed that Prestalia provided rapid and sustained blood pressure control in one convenient pill," Emerson added.
The Prestalia NDA is primarily supported by data from the 837-patient Phase III PATH trial (Perindopril Amlodipine for the Treatment of Hypertension).
The principal investigator for the PATH trial George Bakris said, "The clinical outcomes from the Phase III PATH study suggest that Prestalia could offer an effective as well as convenient option for patients."
Prestalia, if approved, will be offered through Symplmed’s proprietary web portal, DyrctAxess.
The Prescription Drug User Fee Act (PDUFA) goal date for Prestalia is January 21, 2015.