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Publication Number
US-11139056-B2
Publication Date
2021-10-05
Expiration Date
Abstract
The present disclosure relates to compositions, kits, uses, systems and methods for treating overweight and obesity using naltrexone plus bupropion, preferably in combination with a comprehensive web-based and/or telephone-based weight management program, and preferably in subjects at increased risk of adverse cardiovascular outcomes.
Core Innovation
The invention provides a method of treating overweight or obesity in a subject at increased risk of a major adverse cardiovascular event. The method administers an amount of sustained release naltrexone together with an amount of sustained release bupropion to the overweight or obese subject.
The subject is at increased risk of a major adverse cardiovascular event based on a diagnosis of cardiovascular disease with at least one risk factor selected from documented myocardial infarction, a history of coronary revascularization, angina with ischemic changes, ECG changes on a graded exercise test, a positive cardiac imaging study, an ankle brachial index <0.9 assessed by simple palpation within prior 2 years, and >50% stenosis of a coronary, carotid, or lower extremity artery within prior 2 years of identification.
In some embodiments, the method includes treating for at least 16 weeks. In further embodiments, the sustained release naltrexone and sustained release bupropion are administered in a tablet containing 8 mg sustained release naltrexone and 90 mg sustained release bupropion.
Where specified, the major adverse cardiovascular event categories include cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, and the treatment is so as not to increase the subject’s risk of an adverse cardiovascular outcome.
Claims Coverage
The partial content includes three independent claims covering treatment of overweight or obesity with sustained release naltrexone plus sustained release bupropion in an increased-risk cardiovascular population. The inventive features focus on the drug combination, dose ranges, defined cardiovascular risk criteria, treatment duration, tablet formulation, and major adverse cardiovascular event categories.
Sustained release naltrexone and sustained release bupropion treatment for overweight or obesity
A method administering to an overweight or obese subject at increased risk of a major adverse cardiovascular event an amount of sustained release naltrexone and an amount of sustained release bupropion, in the stated daily dose ranges.
Increased risk of a major adverse cardiovascular event based on defined cardiovascular disease risk factors
The subject is at increased risk of a major adverse cardiovascular event if diagnosed as having cardiovascular disease with at least one specified risk factor selected from documented myocardial infarction, coronary revascularization history, angina with ischemic changes, ECG changes on a graded exercise test, positive cardiac imaging study, ankle brachial index <0.9, and >50% stenosis of a coronary, carotid, or lower extremity artery.
Sustained treatment duration of at least 16 weeks
The subject is treated for at least 16 weeks.
Tablet containing 8 mg sustained release naltrexone and 90 mg sustained release bupropion
The sustained release naltrexone and sustained release bupropion are administered in a tablet containing 8 mg sustained release naltrexone and 90 mg sustained release bupropion.
Major adverse cardiovascular event defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke
The major adverse cardiovascular event is cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.
Collectively, the independent claims cover treating overweight or obesity in subjects at increased risk of a major adverse cardiovascular event by administering sustained release naltrexone plus sustained release bupropion in specified daily dose ranges, with increased-risk eligibility defined by cardiovascular disease and risk factors. Additional claim coverage includes a minimum treatment duration, a specific tablet strength, and definition of major adverse cardiovascular events as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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