Spironolactone Oral Suspension Formulation Approved by FDA

CMP Pharma announced that the Food and Drug Administration (FDA) has approved CaroSpir (spironolactone oral suspension), the first oral liquid formulation of spironolactone serving as a new treatment option for adults who have difficulty swallowing or cannot swallow tablets. 

CaroSpir is indicated to treat NYHA Class III–IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure. It is also indicated as add-on therapy for the treatment of hypertension, to lower blood pressure. In addition, it is indicated for the management of edema in adult patients with cirrhosis when edema is not responsive to fluid and sodium restrictions. 

CaroSpir, an aldosterone antagonist, works primarily through competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted renal tube. It causes increased amounts of sodium and water to be excreted, while retaining potassium. 

CaroSpir will be available as a 25mg/5mL strength, banana flavored suspension in 118mL and 473mL bottles. It is anticipated to launch in the 4th quarter of 2017.

Reference

CMP Pharma, Inc. announces FDA approval of CaroSpir® (spironolactone oral suspension, 25 mg/5 mL) [press release]. Farmville, NC: CMP Pharma Inc. Published August 7, 2017. Accessed August 15, 2017. 

This article originally appeared on MPR