FDA approves Symplmed's Prestalia combo for hypertension

Symplmed Pharmaceuticals LLC (Cincinnati, Ohio) said FDA approved an NDA for Prestalia to treat hypertension. The company plans to launch the fixed-dose combination of perindopril arginine plus amlodipine besylate this quarter through its bpCareConnect program, which ships directly to patients who are members of the company's hypertension management program.

The approval was based on results from the 837-patient Phase III PATH trial, in which the oral, once-daily angiotensin-converting enzyme (ACE) inhibitor plus calcium channel blocker produced significantly greater reductions in both seated DBP and SBP from baseline to week 6 compared to either perindopril or amlodipine alone. Prestalia is the first fixed-dose combination of these two medications approved in the U.S. It is indicated for use in patients whose blood pressure is not adequately controlled on monotherapy. ...