CMP Pharma Announces FDA Approval of CaroSpir

CMP Pharma announced the US Food and Drug Administration (FDA) has granted final approval of the company’s New Drug Application (NDA) for CaroSpir (Spironolactone Oral Suspension, 25 mg/5mL), the first and only FDA-approved oral liquid dosage form of the 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," said Gerald Sakowski, CEO at CMP Pharma. "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."

CaroSpir (spironolactone oral suspension) is indicated for treatment of 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, and is usually administered in conjunction with other therapies. CaroSpir is also indicated for use as an add-on therapy for the treatment of hypertension, to lower blood pressure in adult patients who are not adequately controlled on other agents, and as part of comprehensive cardiovascular risk management. Lastly, CaroSpir is indicated for the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restriction.