FDA Approvals: Aceon, 0.1% Alphagan P, Namenda Oral Solution

Yael Waknine

August 25, 2005

Aug. 25, 2005 — The U.S. Food and Drug Administration (FDA) has approved once-daily perindopril erbumine tablets for use alone or in combination with concurrent therapy to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction in patients with stable coronary artery disease; 0.1% formulation of brimonidine tartrate ophthalmic solution that reduces drug exposure without compromising efficacy compared with the 0.2% strength; and an oral solution formulation of memantine.

Perindopril Erbumine (Aceon) for Stable Coronary Artery Disease

On Aug. 23, the FDA approved a new indication for perindopril erbumine (Aceon 2-, 4-, and 8-mg tablets, made by Solvay Pharmaceuticals, Inc., and CV Therapeutics, Inc., under license from Servier International), allowing its use in reducing the risk of cardiovascular mortality or nonfatal myocardial infarction (MI) in patients with stable coronary artery disease.

The approval was based on data from the European Trial on Reduction of Cardiac Events with Perindopril in Patients with Stable Coronary Artery Disease (EUROPA) that involved 12,218 patients randomized to receive perindopril or placebo in addition to standard preventive therapies (aspirin, statins, and beta-blockers) for an average of 4.2 years.

Results showed that the addition of once-daily perindopril yielded a 20% decrease in risk for the combined primary end points of cardiovascular mortality, nonfatal MI, and cardiac arrest compared with standard therapy alone (P = .0003). The risk of myocardial infarction (fatal or nonfatal) was reduced by 24% (P < .001) and the risk of heart failure by 39% (P = .002).

The benefit of perindopril therapy on primary outcomes was evident after about one year of therapy, with consistent effects across patient subgroups varying in age, underlying disease such as hypertension and diabetes, and concurrent optimal preventive therapies.

Cough, drug intolerance, and hypotension were more commonly reported as reasons for therapy discontinuation in perindopril-treated patients compared with those receiving placebo (overall discontinuation rate, 22% for both groups).

In patients with coronary artery disease, perindopril should be initiated at a dose of 4 mg daily (2 mg/day in patients aged > 70 years) for two weeks, and then increased as tolerated to a maintenance dose of 8 mg/day.

Perindopril erbumine (Coversyl 4-mg tablets, made by Servier International) was previously approved for this indication by the European Commission (EC), and by the FDA and EC for the treatment of essential hypertension.

Brimonidine Tartrate 0.1% (Alphagan P) — Less Drug, Same Efficacy

On Aug. 19, the FDA approved a 0.1% formulation of brimonidine tartrate ophthalmic solution (Alphagan P, made by Allergan, Inc.) for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

The approval was based on study data showing that the 0.1% and 0.2% (Alphagan) formulations were similarly effective for reducing IOP by approximately 2 to 6 mm Hg when administered three times daily.

The product's increased bioavailability allows a further decrease in drug exposure compared with that afforded by the previously approved and equally effective 0.15% formulation.

Memantine Oral Solution (Namenda) for Alzheimer's Disease

On Aug. 18, memantine HCl 2 mg/mL oral solution (Namenda, marketed by Forest Laboratories, Inc., under license from Merz Pharma GmbH & Co.) was launched in the U.S. market. It was originally approved by the FDA on April 18, 2005, but was not previously reported on in this column.

The solution is equivalent on a milligram per milligram basis to the 5- and 10-mg tablets and is availablein 360-mL (12-oz) bottles.

Memantine HCl tablets and oral solution are indicated for the treatment of moderate to severe Alzheimer's disease.

Reviewed by Gary D. Vogin, MD

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