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Publication Number
US-10403170-B2
Publication Date
2019-09-03
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 is directed to a method of treating a subject at increased risk of a major adverse cardiovascular event for overweight or obesity by administering a therapeutically effective amount of sustained release naltrexone and sustained release bupropion. The sustained release naltrexone is 32 mg per day, or a pharmaceutically acceptable salt thereof, and the sustained release bupropion is 360 mg per day, or a pharmaceutically acceptable salt thereof. The subject is treated for at least 16 weeks.
The subject is defined as overweight or obese and as having cardiovascular disease with at least one risk factor selected from specified categories. The risk-factor categories include a history of documented myocardial infarction, a history of coronary revascularization, angina with ischemic changes or related diagnostic findings, ankle brachial index less than 0.9 assessed by simple palpation, and a specified degree of stenosis in coronary, carotid, or lower extremity arteries within a defined period.
The invention also defines the major adverse cardiovascular event endpoint as cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. In the described materials, nonfatal unstable angina requiring hospitalization is also included. Administration implementations include a tablet containing 8 mg sustained release naltrexone and 90 mg sustained release bupropion, and split dosing of the sustained release amounts into multiple discrete doses given twice daily.
Claims Coverage
The provided claim set includes three independent claims. Across these independent claims, the inventive coverage is anchored on sustained release naltrexone plus sustained release bupropion at specified daily amounts, treatment of overweight or obesity subjects whose cardiovascular risk is defined by specified cardiovascular disease risk-factor criteria, and treatment duration and endpoint definitions, with additional claim scope for tablet formulation and dosing regimen.
Treating overweight or obesity at increased major adverse cardiovascular event risk with sustained release combination
A method of treating an overweight or obese subject at increased risk of a major adverse cardiovascular event by administering 32 mg per day sustained release naltrexone, or a pharmaceutically acceptable salt thereof, and 360 mg per day sustained release bupropion, or a pharmaceutically acceptable salt thereof, wherein the subject is treated for at least 16 weeks.
Cardiovascular-disease risk-factor eligibility for increased major adverse cardiovascular event risk
Eligibility is based on diagnosis of cardiovascular disease with at least one risk factor selected from a history of documented myocardial infarction, history of coronary revascularization, angina with ischemic changes or related findings, ankle brachial index less than 0.9 assessed by simple palpation, and greater than 50% stenosis of a coronary, carotid, or lower extremity artery within the specified time windows.
Tablet containing sustained release naltrexone and sustained release bupropion for administration
Administering the sustained release naltrexone and sustained release bupropion in a tablet containing 8 mg of sustained release naltrexone and 90 mg of sustained release bupropion.
Major adverse cardiovascular event definition
Wherein the major adverse cardiovascular event is cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.
Twice-daily split dosing of sustained release naltrexone and sustained release bupropion
Administering sustained release naltrexone as two 8 mg doses twice daily and sustained release bupropion as two 90 mg doses twice daily.
The independent-claim coverage focuses on a sustained-release naltrexone plus sustained-release bupropion regimen at specified daily amounts for overweight or obesity subjects with cardiovascular-disease risk-factor eligibility criteria. The claim scope further specifies the treatment duration, the major adverse cardiovascular event endpoints, and administration implementations including a defined tablet formulation and twice-daily split dosing.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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