FDA green-lights CMP Pharma’s CaroSpir

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FDA green-lights CMP Pharma’s CaroSpir

By David Salazar - 08/07/2017

SILVER SPRING, Md. — CMP Pharma on Monday announced that the Food and Drug Administration had approved its CaroSpir (spironolactone oral suspension, 25 mg/5ml). The company said it’s the only FDA-approved liquid dosage form of potassium-sparing diuretic spironolactone.


“CaroSpir provides a stable, ready to use and consistent liquid treatment option for adult patients, including those who have difficulty swallowing, or who cannot swallow tablets,” CMP Pharma CEO Gerald Sakowski said. “Up until now, these patients have been prescribed a pharmacy compounded liquid form of spironolactone.  The dosing inconsistencies of compounded liquids have long been a persistent challenge for physicians.”


The drug is indicated to treat NYHA class III-IV heart failure and reduced ejection fraction to increase survival, as well as to manage edema and reduce the need for hospitalization for heart failure. It also is indicated as an add-on therapy to treat hypertension, lower blood pressure in patients not adequately controlled on other agents and as part of cardiovasulvar risk management. It also can help manage edema in adult cirrhotic patients whose edema is not responsive to fluid and sodium restrictions.


The company expects the treatment to be available in the fourth quarter of 2017.


 


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