Compositions and methods for reducing major adverse cardiovascular events
Inventors
Klassen, Preston • Taylor, Kristin
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11998542-B2
Publication Date
2024-06-04
Expiration Date
Abstract
The present application relates to compositions, kits, uses, systems and methods of using naltrexone and bupropion, or pharmaceutically acceptable salts thereof, for reducing the risk of adverse cardiovascular outcomes or events, including Major Adverse Cardiovascular Events (MACE) in subjects, preferably those at increased risk of adverse cardiovascular outcomes or MACE, that may be overweight or obese. The present application also relates to compositions, kits, uses, systems and methods of using naltrexone and bupropion or pharmaceutically acceptable alts thereof for treatment of overweight or obesity in subjects, preferably at increased risk of adverse cardiovasular outcomes or MACE, wherein the treatment reduce, the risk of MACE.
Core Innovation
The disclosure provides methods of administering naltrexone and bupropion to a subject having an increased risk of a major adverse cardiovascular event (MACE). In particular, the subject is a smoker, and naltrexone and bupropion are administered as daily doses within defined ranges for a treatment period of at least 1 week. The approach includes administering pharmaceutically acceptable salts of naltrexone and bupropion.
The disclosure also addresses reducing the risk of MACE in a smoker by administering naltrexone and bupropion daily, where the administering reduces the risk of MACE compared to a smoker not receiving the daily dose. The MACE is described in terms of specific cardiovascular events and components, and the clinical-study background relates to cardiovascular safety considerations. The disclosure includes discussion of MACE endpoints and observed treatment effects compared to placebo.
In additional refinements described in the claims and supported by the disclosure, the methods include optional refinements such as sustained-release formulation and defined dosing regimens over multiple weeks. The disclosure describes sustained release formulations for administering naltrexone and bupropion, and describes a week-by-week dose-escalation regimen for daily dosing across early weeks and subsequent weeks. The methods also include defining particular salt forms for naltrexone and bupropion.
Claims Coverage
The partial content contains two independent claims directed to (i) a method of administering naltrexone and bupropion to a smoker at increased risk of MACE, and (ii) a method of reducing risk of MACE in a smoker by administering those daily doses compared to smokers not receiving them. Across the independent claims, the key inventive features relate to the smoker population, the MACE risk reduction purpose, the specified daily dose ranges of naltrexone and bupropion (including pharmaceutically acceptable salts), and a minimum treatment period.
Smoker at increased risk of MACE using daily naltrexone and bupropion doses
Administering daily doses of 4-50 mg of naltrexone (or a pharmaceutically acceptable salt thereof) and 50-400 mg of bupropion (or a pharmaceutically acceptable salt thereof) to a subject having an increased risk of a major adverse cardiovascular event (MACE), wherein the subject is a smoker, for a treatment period of at least 1 week.
Reducing MACE risk in smokers using daily naltrexone and bupropion doses compared to not receiving
Administering to the smoker daily doses of 4-50 mg of naltrexone (or a pharmaceutically acceptable salt thereof) and 50-400 mg of bupropion (or a pharmaceutically acceptable salt thereof) for a treatment period of at least 1 week, wherein the administering reduces the risk of MACE compared to a smoker not receiving the daily dose of naltrexone (or its pharmaceutically acceptable salt) and bupropion (or its pharmaceutically acceptable salt).
The claims cover administering and using naltrexone plus bupropion as daily dosing to smokers for at least 1 week to treat increased MACE risk and to reduce MACE risk compared to smokers not receiving the daily dose. Additional claim refinements in the partial content further support specific MACE event definitions, optional sustained release formulation, defined dosing escalation across early weeks, and specific pharmaceutically acceptable salt forms.
Stated Advantages
Reducing the risk of major adverse cardiovascular events (MACE) in a smoker compared to a smoker not receiving the daily dose.
Documented Applications
Use of the disclosed naltrexone and bupropion methods to reduce risk of major adverse cardiovascular events (MACE) in smokers, including smokers at increased CV risk.
Interested in licensing this patent?