• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Contrave (naltrexone HCl and bupropion HCl)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Contrave (naltrexone HCl and bupropion HCl)

  • Profile

Profile

Contact Information

Currently Enrolling Trials

    Show More

    General Information

    Contrave is  combination of naltrexone, an opioid antagonist, and bupropion, an inhibitor of the neuronal reuptake of dopamine and norepinephrine. 

    Contrave is specifically indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of: 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity.

    Contrave is supplied as an extended release table for oral administration. Dosing should be escalated according to the following schedule:

    Week 1: Morning dose: 1 tablet Evening dose: no tablet

    Week 2: Morning dose: 1 tablet Evening dose: 1 tablet

    Week 3: Morning dose: 2 tablets Evening dose: 1 tablet

    Week 4 - Onward: Morning dose: 2 tablets Evening dose: 2 tablets

    Patients using Contrave at the maintenance dose should be evaluated after 12 weeks to determine if the treatment is working. If a patient has not lost at least 5 percent of baseline body weight, Contrave should be discontinued.

    Contrave has the potential to cause suicidal thoughts and behaviors and neuropsychiatric reactions.

    Clinical Results

    FDA Approval

    The FDA approval of Contrave was based on multiple clinical trials that included approximately 4,500 obese and overweight patients with and without significant weight-related conditions treated for one year. All patients received lifestyle modification that consisted of a reduced- calorie diet and regular physical activity.

    Results from a clinical trial that enrolled patients without diabetes showed that patients had an average weight loss of 4.1% over treatment with placebo (inactive pill) at one year. In this trial, 42% f patients treated with Contrave lost at least 5 percent of their body weight compared with 17% of patients treated with placebo. Results from another clinical trial that enrolled patients with type 2 diabetes showed that patients had an average weight loss of 2% over treatment with placebo at one year. In this trial, 36% of patients treated with Contrave lost at least 5 percent of their body weight compared with 18% of patients treated with placebo.

    Side Effects

    Adverse effects associated with the use of Contrave may include, but are not limited to, the following:

    • nausea
    • constipation
    • headache
    • vomiting
    • dizziness
    • insomnia 
    • dry mouth
    • diarrhea

    Mechanism of Action

    Contrave is  combination of naltrexone, an opioid antagonist, and bupropion, an inhibitor of the neuronal reuptake of dopamine and norepinephrine. Nonclinical studies suggest that naltrexone and bupropion have effects on two separate areas of the brain involved in the regulation of food intake: the hypothalamus (appetite regulatory center) and the mesolimbic dopamine circuit (reward system). The exact neurochemical effects of Contrave leading to weight loss are not fully understood. 

    Additional Information

    For additional information regarding Contrave or chronic weight management, please visit http://www.takeda.us/

    Approval Date: 2014-09-01
    Company Name: Takeda Pharmaceuticals U.S.A.
    Back to Listings

    Upcoming Events

    • 26Jan

      Reducing Complexity in Starting Clinical Trials – More Patients, Faster Startup

    • 27Jan

      Medical Device Clinical Trials in China: Latest Regulatory Developments

    • 11Feb

      Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era

    • 23Mar

      Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

    • 26Apr

      MAGI's Clinical Research vConference — Spring 2021

    Featured Products

    • Regenerative Medicine – Steps to Accelerate Development : PDF

      Regenerative Medicine: Steps to Accelerate Development

    • Clinical Trial Agreements — A Guide to Key Words and Phrases : PDF

      Clinical Trial Agreements: A Guide to Key Words and Phrases

    Featured Stories

    • Resources-360x240.png

      Trial Complexity, Endpoints Continue to Increase, Stretching Site Resources

    • FocusinRed-360x240.png

      Return to Focus on Risk Management Postpandemic Could Prove Challenging to Sites

    • VaccinewithNeedle-360x240.png

      2021 Vaccine Industry Will Continue to be Dominated by COVID-19 Trials, Experts Say

    • Dominate-360x240.png

      COVID-19, Oncology, CNS and Infectious Disease Trials Will Dominate in 2021, Survey Predicts

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell My Personal Information

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing