New Fixed-Dose Combo Tabs for Hypertension Approved

Symplmed announced that the Food and Drug Administration (FDA) has approved Prestalia (perindopril arginine and amlodipine) tablets for the treatment of hypertension in patients whose blood pressure is uncontrolled on monotherapy. Prestalia is the first fixed-dose combination of these two ingredients.

Prestalia combines perindopril arginine, an angiotensin converting enzyme (ACE) inhibitor, and amlodipine, a dihydropyridine calcium channel blocker (CCB). Perindopril and amlodipine are individually approved for the treatment of hypertension and coronary artery disease.

The approval of Prestalia was supported by data from the Phase 3 PATH trial (n=837). The study showed that the fixed-dose combination of perindopril arginine with amlodipine besylate as a single pill was significantly better than either compound alone in the reduction of both sitting diastolic and sitting systolic blood pressure after 6 weeks of treatment. It also suggested that the combination may offer a better benefit/risk ratio than either treatment alone.

Prestalia tablets will be available in 3.5mg/2.5mg, 7mg/5mg, and 14mg/10mg strengths within the first quarter of 2015 through bpCareConnect, its hypertension management program.

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