Sun Pharma launches novel drug Kapspargo Sprinkle in US market

Sun Pharma launches

Sun Pharmaceutical Industries Ltd. has launched Kapspargo Sprinkle (metoprolol succinate) extended-release capsules in the US, for the treatment of hypertension (to lower blood pressure), angina pectoris (chest pain), and heart failure (to reduce the risk of cardiovascular mortality and heart-failure hospitalization in patients with heart failure). Kapspargo Sprinkle, a US Food and Drug Administration (FDA) approved, novel, patented formulation of metoprolol succinate, is the first and only extended-release sprinkle formulation of this beta1-selective adrenoreceptor blocking agent (beta-blocker). It is covered by United States Patent numbers 9,504,655 and 9,700,530, expiring July 09, 2035. Kapspargo Sprinkle pellets can be sprinkled over soft food (such 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 non-adherence to medications as well as medication errors,” said Abhay Gandhi, CEO-North America, Sun Pharma. “Kapspargo Sprinkle capsules may make it easier for patients to take their antihypertensive medication.

This innovative product is the latest example of Sun Pharma’s use of advanced technology to create novel formulations of proven medications.” 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 is contraindicated in patients with (1) known hypersensitivity to the product components; (2) severe bradycardia, greater than first-degree heart block, or sick sinus syndrome without a pacemaker; and (3) cardiogenic shock or decompensated heart failure. In clinical trials, most common adverse reactions were tiredness, dizziness, depression, shortness of breath, bradycardia, hypotension, diarrhea, pruritus, and rash.

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