Inspra to Launch This Year
More than a year after receiving initial marketing approval from the Food and Drug Administration (FDA), Pfizer Inc. appears ready to launch eplerenone, a selective aldosterone blocker to be sold under the brand name Inspra.
FDA initially approved eplerenone last year for the treatment of hypertension. Pfizer, which acquired the product through the company's merger with Pharmacia Corp., delayed marketing the product while it was under FDA priority review for a new indication, the treatment of congestive heart failure (CHF) secondary to an acute myocardial infarction.
FDA announced today that it has approved the CHF indicationa first for any drug in the class. According to the agency, eplerenone therapy was associated with a 15 percent reduction in the risk of death in a placebo-controlled clinical trial involving myocardial infarction survivors with CHF. A Pfizer press release noted that patients in the study received standard therapy, including beta-blockers and angiotensin-converting-enzyme inhibitors, along with eplerenone or placebo.
Revised labeling covering the CHF indication was not available at press time.
According to the product's previously approved labeling (PDF), Eplerenone is contraindicated in patients with a high potassium level, renal insufficiency, or diabetes mellitus associated with microalbuminuria or who are taking a potassium supplement or potassium-sparing diuretic.
The previously approved labeling states that eplerenone will be available in 25-, 50-, and 100-mg tablets in 30- and 90-count bottles and in unit dose packages. The recommended starting dosage for the hypertension indication is 50 mg once daily, taken alone or with other antihypertensive medications.
Pfizer announced that it will make eplerenone available to patients with CHF next month through an "Early Access" program. The company expects the product to be available in pharmacies in December.