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FDA Approves First Oral-Liquid Form of Heart Failure Drug Spironolactone
The FDA has granted final approval of spironolactone oral suspension, 25 mg/5 mL (CaroSpir, CMP Pharma), the first FDA-approved oral liquid dosage form of the potassium-sparing diuretic spironolactone. The company plans to introduce it early in the fourth quarter of 2017.
According to the company, the new formulation provides a stable, ready-to-use, and consistent liquid treatment option for adult patients, especially those who have difficulty swallowing or who are unable to swallow tablets. “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,” said Gerald Sakowski, CEO of CMP Pharma.
Spironolactone oral suspension is indicated for the treatment of New York Heart Association Class III–IV heart failure and reduced ejection fraction to increase survival, manage edema, and reduce the need for hospitalization for heart failure, and is usually administered in conjunction with other therapies. Spironolactone oral suspension 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, it is indicated for the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restriction.
Spironolactone oral suspension is contraindicated for patients with the following conditions: hyperkalemia, Addison’s disease, and concomitant use of eplerenone. The most common adverse reaction that occurred at an incidence greater than 5% was the increased occurrence of gynecomastia in men.
Source: CMP Pharma; August 7, 2017.