The Food and Drug Administration has cleared Sun Pharma’s Kapspargo Sprinkle (metoprolol succinate) extended-release capsules for the treatment of hypertension to lower blood pressure, angina pectoris for chest pain, and heart failure to reduce the risk of cardiovascular mortality and heart-failure hospitalization in patients with heart failure. The product is the first and only extended-release sprinkle formulation of this beta1-selective adrenoreceptor blocking agent, or beta-blocker, according to the company.
Kapspargo Sprinkle is a novel formulation of metoprolol succinate, a beta1-selective (cardioselective) adrenoreceptor blocking agent, for oral administration. It is available as extended-release capsules that comprise a multiple unit system containing metoprolol succinate in a multitude of controlled-release pellets. Each pellet acts as a separate drug delivery unit that is designed to deliver metoprolol continuously over the dosage interval. The extended-release capsules are available in dosage strengths of 25 mg, 50 mg, 100 mg and 200 mg.
Kapspargo Sprinkle pellets can be sprinkled over such soft foods as applesauce, yogurt or pudding, or administered via a nasogastric tube, and are designed to facilitate long-term, once-daily administration, particularly for patients who have difficulty swallowing.
“Roughly 40% of patients requiring long-term care have difficulty swallowing, a problem that may result in patient nonadherence to medications, as well as medication errors,” Sun Pharma CEO of North America Abhay Gandhi said, in a press statement. “Kapspargo Sprinkle capsules may make it easier for patients to take their antihypertensive medication,” Gandhi said. “This innovative product is the latest example of Sun Pharma’s use of advanced technology to create novel formulations of proven medications.”