FDA approvals

FDA approves fixed-dose combination for patients with hypertension

Symplmed Pharmaceuticals announced that the FDA has approved the fixed-dose combination of perindopril arginine and amlodipine for the treatment of hypertension in patients whose BP is not adequately controlled on monotherapy.

In the event that a patient is likely to require treatment with multiple drugs to achieve target BP, the fixed-dose combination can also be used as initial therapy, according to a press release.

The therapy will be marketed as Prestalia. It is the first to combine perindopril arginine, an ACE inhibitor, with amlodipine, a dihydropyridine calcium channel blocker, according to the release.

The approval follows results from the PATH trial (n=837), which demonstrated that perindopril arginine and amlodipine administered in a single pill yielded significantly greater improvements in sitting diastolic and systolic BP at 6 weeks than either compound alone. According to the release, results from other clinical studies have indicated that these classes of drugs in combination may also reduce the incidence of CV events; however, no controlled trials have indicated a risk reduction with this therapy specifically.

George L. Bakris, MD

George L. Bakris

“We now have another great combination of two drugs, each with an evidence-based outcome history, that are combined in a single pill,” George L. Bakris, MD, former president of the American Society of Hypertension and principal investigator for the PATH trial, stated in the release. Bakris is also a Cardiology Today Editorial Board member.

Availability of the fixed-dose combination is anticipated in the first quarter of 2015, according to the release.

Disclosure: Bakris is principal investigator of the PATH trial.

Symplmed Pharmaceuticals announced that the FDA has approved the fixed-dose combination of perindopril arginine and amlodipine for the treatment of hypertension in patients whose BP is not adequately controlled on monotherapy.

In the event that a patient is likely to require treatment with multiple drugs to achieve target BP, the fixed-dose combination can also be used as initial therapy, according to a press release.

The therapy will be marketed as Prestalia. It is the first to combine perindopril arginine, an ACE inhibitor, with amlodipine, a dihydropyridine calcium channel blocker, according to the release.

The approval follows results from the PATH trial (n=837), which demonstrated that perindopril arginine and amlodipine administered in a single pill yielded significantly greater improvements in sitting diastolic and systolic BP at 6 weeks than either compound alone. According to the release, results from other clinical studies have indicated that these classes of drugs in combination may also reduce the incidence of CV events; however, no controlled trials have indicated a risk reduction with this therapy specifically.

George L. Bakris, MD

George L. Bakris

“We now have another great combination of two drugs, each with an evidence-based outcome history, that are combined in a single pill,” George L. Bakris, MD, former president of the American Society of Hypertension and principal investigator for the PATH trial, stated in the release. Bakris is also a Cardiology Today Editorial Board member.

Availability of the fixed-dose combination is anticipated in the first quarter of 2015, according to the release.

Disclosure: Bakris is principal investigator of the PATH trial.