Prestalia filed with FDA for Hypertension-Symplmed

The FDA has accepted for review an New Drug Application (NDA) for investigational drug Prestalia, the first single-pill, fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate, from Symplmed, for the treatment of Hypertension. The Prestalia NDA is primarily supported by data from the 837-patient Phase III PATH trial 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 study indicated that the combination may provide a better benefit/risk ratio than either treatment alone. If approved, Symplmed would offer Prestalia through its proprietary web portal, DyrctAxess, as part of a comprehensive hypertension-management offering.