Novel combo hypertension drug gets FDA nod

Perindopril arginine and amlodipine besylate may be used as initial therapy if a patient is likely to need multiple drugs to achieve their blood pressure goals.

Prestalia earns FDA approval
Prestalia earns FDA approval

Perindopril arginine and amlodipine besylate (Prestalia) tablets have been approved by the FDA for the treatment of hypertension. The first fixed-dose combination of these two medications may be used in patients whose blood pressure is not adequately controlled on monotherapy.

Perindopril arginine and amlodipine may be used as initial therapy if a patient is likely to need multiple drugs to achieve their blood pressure goals.

“With ACE inhibitors and calcium channel blockers being two of the most highly prescribed products for the treatment of cardiovascular disease, we are excited to be able to provide physicians and patients these two therapeutic classes in a single pill combination right from the start of the treatment for hypertension,” said Erik Emerson, President and CEO of Symplmed Pharmaceuticals in a press release.

FDA approval of combination perindopril arginine and amlodipine besylate tablets was based on data from 837 patients enrolled in a Phase III PATH trial. The study demonstrated that the fixed-dose combination of perindopril arginine with amlodipine besylate in a single pill was significantly better than either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after six weeks of treatment.

The study's results also suggested that the combination may provide a better benefit/risk ratio than either treatment alone. There are additional clinical studies that demonstrate use of these classes of drugs together may reduce cardiovascular events.

“We now have another great combination of two drugs each with an evidence based outcome history that are combined in a single pill,” said George Bakris, MD, former president of the American Society of Hypertension and investigator for the PATH trial.

Symplmed plans to make the combination tablet available to providers and patients within the first quarter of 2015 through its hypertension management program, bpCareConnect.

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