What you need to know about the new weight loss drug – Contrave!
What is the new weight loss drug Contrave?
Contrave is a sustained release formulation of two medications – Bupropion and Naltrexone, approved by the US Food and Drug Administration in September 2014 as an option for weight loss in addition to a reduced-calorie diet and physical activity in those who are obese or overweight with certain weight related comorbidities.
Who can take Contrave for weight loss?
Contrave(Bupropion Naltrexone) is approved for use in adults with a body mass index (BMI) of 30 or greater (obesity) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).
What is Body Mass Index?
BMI or body mass index, is a simple and easy measure of body fat based on an individual’s weight and height, is used to define the obesity and overweight categories. According to the statistics from the Centers for Disease Control and Prevention, more than one-third of adults in the United States are obese.
- 35.1% of adults age 20 years and over who are obese as per data from 2011-2012.
- 69.0% of adults age 20 years and over who are overweight, including obesity as per data from 2011-2012.
Children and adolescents
- 18.4% of adolescents age 12-19 years who are obese as per data from 2009-2010.
- 18.0% of children age 6-11 years who are obese as per data from 2009-2010.
- 12.1% of children age 2-5 years who are obese as per data from 2009-2010.
Why it is important to tackle obesity?
According to the FDA release announcing the approval of Contrave:
“Obesity continues to be a major public health concern,” said Jean-Marc Guettier, M.D., director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research. “When used as directed in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, Contrave provides another treatment option for chronic weight management for people who are obese or are overweight and have at least one weight-related health condition.”
Two existing FDA approved medications combined for synergistic effect on weight loss!
Similar to the other FDA approved combination medication, Qsymia(Phentermine and Topiramate), Contrave is a combination of two FDA-approved drugs, naltrexone and bupropion, in an extended-release formulation.
What is Naltrexone?
Naltrexone is approved to treat alcohol and opioid dependence.
What is Bupropion?
Bupropion is approved to treat depression and seasonal affective disorder and as an aid to smoking cessation treatment.
How effective is Contrave for weight loss?
The effectiveness of Contrave was evaluated in multiple clinical trials that included approximately 4,500 obese and overweight patients with and without significant weight-related comorbid conditions treated for one year all of whom received lifestyle modification that consisted of a reduced- calorie diet and regular physical activity.
Contrave weight loss results in non-diabetic patients
In patients without diabetes taking Contrave showed that patients had an average weight loss of 4.1 percent over treatment with placebo (inactive pill) at one year. In this study assessing the effectiveness of Contrave, 42 percent of patients treated with Contrave lost at least 5 percent of their body weight compared with 17 percent of patients treated with placebo.
Contrave weight loss results in diabetic patients
Results from another study assessing the safety and effectiveness of Contave that enrolled patients with type 2 diabetes showed that patients had an average weight loss of 2 percent over treatment with placebo at one year. In this study, 36 percent of patients treated with Contrave lost at least 5 percent of their body weight compared with 18 percent of patients treated with placebo.
How long should I try Contrave before knowing whether it works for me?
According to the FDA, 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 their baseline body weight, Contrave should be discontinued, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.
Warnings and precautions of Contrave!
Because it contains bupropion, FDA requires Contrave have a boxed warning to alert health care professionals and patients to the increased risk of suicidal thoughts and behaviors associated with antidepressant drugs although in clinical practice, Bupropion is considered relative well tolerated. The warning from FDA also notes that serious neuropsychiatric events have been reported in patients taking bupropion for smoking cessation.
Contra-indications for use of Contrave for weight loss
Contrave can cause seizures by decreasing the seizure threshold and must not be used in patients who have seizure disorders. The risk of seizure is dose-related and is minimal in clinical practice. Contrave should be discontinued and not restarted in patients who experience a seizure while being treated with Contrave.
Contrave and effect
Contrave can increase blood pressure and heart rate and must not be used in patients with uncontrolled high blood pressure although the clinical significance of the increases in blood pressure and heart rate observed with Contrave treatment is unclear, especially for patients with heart-related and cerebrovascular (blood vessel dysfunction impacting the brain) disease, since patients with a history of heart attack or stroke in the previous six months, life-threatening arrhythmias, or congestive heart failure were excluded from the clinical trials. According to the statement from the FDA, the blood pressure and pulse should be measured prior to starting the drug and should be monitored at regular intervals, particularly among patients with controlled high blood pressure prior to treatment.
Who should not take Contrave?
- Other products containing bupropion.
- In patients who have eating disorders (bulimia or anorexia nervosa).
- Patients who are using opioids or treatments for opioid dependence, or who are experiencing acute opiate withdrawal.
- Patients undergoing an abrupt discontinuation of alcohol, benzodiazepines, barbiturates and antiepileptic drugs should not take Contrave.
- Women who are pregnant or trying to become pregnant should not take Contrave.
Side effects of Contrave!
The most common adverse reactions reported with Contrave include nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea.
The FDA is requiring the following post-marketing requirements:
- a cardiovascular outcomes trial to assess the cardiovascular risk associated with Contrave use;
- two efficacy, safety, and clinical pharmacology studies in pediatric patients (one in patients 12 to 17 years of age, and one in patients 7 to 11 years of age);
- a nonclinical (animal) juvenile toxicity study with a particular focus on growth and development as well as behavior, learning, and memory;
- a study to evaluate the effect of Contrave on cardiac conduction;
- clinical trials to evaluate dosing in patients with hepatic or renal impairment;
- a clinical trial to evaluate the potential for interactions between Contrave and other drugs.
Price of Contrave
The pricing of Contrave is more competitive compared to the other new weight loss medications, Belviq, Qsymia or Saxenda! With the manufacturer coupon available via W8MD medical weight loss centers offices or other physicians prescribing Contrave, the price of Contrave can be as low as $70.00 even without insurance and with insurance it can be about $55.00 or less.
Availability of Contrave
Contrave is a prescription medication available via many weight loss physician offices including W8MD medical weight loss centers of America’s locations.
Locations of W8MD physicians familiar with the use, indications and effectiveness of Contrave
King Of Prussia Weight Loss & Sleep Center: 987 Old Eagle School Rd, Ste 712, Wayne, PA, 19087 Ph: 215-676-2334
Our farthest patient comes from Delaware! Testimonials
NYC Insurance Weight Loss & Sleep Center: 2003, Bath Avenue, Brooklyn, NY, 11214 Ph: 1-718-946-5500.
Our farthest patient comes from Dallas, Texas! Testimonials
W8MD medical weight loss program at Vida Sleep Center of Dr. Felix Roque’s office at 543, 45th Street, Union City, New Jersey. 543 45th St, Union City, NJ 07087. Phone: (201) 766-6469. This center bills out of network for insurance.
Contrave is distributed by Takeda Pharmaceuticals America Inc. of Deerfield, Illinois for Orexigen Therapeutics, Inc. of La Jolla, California.