FDA approves Contrave for weight loss
The United States Food and Drug Administration approved Contrave, a combination of naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.
Indications for use of Contrave weight loss medication
Contrave 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) that have at least one weight-related comorbidity such as high blood pressure (hypertension), type 2 diabetes, sleep apnea, metabolic syndrome or high cholesterol (dyslipidemia).
Body Mass Index or BMI, measures body fat based on an individual’s weight and height, is used to define the obesity and overweight categories. According to the Centers for Disease Control and Prevention, more than one-third of adults in the United States are obese defined as a BMI of 30 or over and another third are in the overweight category as noted b
CDC Adult Obesity Rate
Percent of adults age 20 years and over who are obese: 35.1% (2011-2012)
Percent of adults age 20 years and over who are overweight, including obesity: 69.0% (2011-2012
CDC Children and adolescents
Percent of adolescents age 12-19 years who are obese: 18.4% (2009-2010)
Percent of children age 6-11 years who are obese: 18.0% (2009-2010)
Percent of children age 2-5 years who are obese: 12.1% (2009-2010)
Obesity is a Major Public Health Problem
“Obesity continues to be a major public health concern,” according to 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.”
Contrave is a combination of two FDA-approved drugs that have been on the market for quite sometime, naltrexone and bupropion, in an extended-release formulation. Naltrexone is approved to treat alcohol and opioid dependence and Bupropion is approved to treat depression and seasonal affective disorder and as an aid to smoking cessation treatment. However, the combination of these two medications is now approved for weight loss.
The effectiveness of the weight loss drug Contrave was evaluated in 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 in addition to the weight loss medication contrave.
Results from a clinical trial that enrolled non-diabetic patients showed that patients had an average weight loss of 4.1 percent over treatment with placebo at one year. In this trial designed to assess the efficacy of contrave for weight loss, 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. Results from another clinical trial that enrolled patients that have type 2 diabetes showed that patients had an average weight loss of 2 percent over treatment with placebo at one year. In this trial, 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.
In general, Contrave (Naletrexone/Bupropion) is likely to be less effective than Qsymia, a bit more effective than Belviq as trials of those taking Qsymia lost an average of 9 percent of their body weight, while those taking Belviq lost an average of just 3 percent. Clinical trials show those taking Contrave lost an average of 5 percent of their body weight in the same period.
So, 9 percent of weight loss for Phentermine/Topirmate (Qsymia), 5 percent for Bupropion/Naltrexone(Contrave) and 3 percent for Lorcaserin(Belviq)!
12 week trial
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, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.
Standard Boxed Warning Related to Bupropion
Because it contains bupropion, Contrave has 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 this is not seen that often. The warning also notes that serious neuropsychiatric events have been reported in patients taking bupropion for smoking cessation.
Contrave can cause seizures and must not be used in patients who have seizure disorders. The risk of seizure is dose-related. Contrave should be discontinued and not restarted in patients who experience a seizure while being treated with Contrave.
Contrave can also raise blood pressure and heart rate and must not be used in patients with uncontrolled high blood pressure. 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. 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.
Other products containing bupropion should not be taken along with Contrave. The drug should not be used in patients who have eating disorders (bulimia or anorexia nervosa). Contrave should also not be taken by 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.
Adverse reactions to 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.
Contrave is distributed by Takeda Pharmaceuticals America Inc. of Deerfield, Illinois for Orexigen Therapeutics, Inc. of La Jolla, California.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products
Contrave is probably the most cost effective of the three new weight loss medications approved in the last few years, the other two being Qsymia, Belviq. The other new medications Belviq and Qsymia can cost up to $150-225 dollars per month.
Costing about $70.00 dollars a month without insurance first two months, drops to $60.00 thereafter, contrave is very cost effective. For those that have insurance, the maximum monthly cost is $55.00 for the first two months that drops to $45.00 after the first two months.
As of 2014, the drug is marketed in the United States in a sustained release formulation under the name Contrave by Takeda for the drug’s developer, Orexigen Therapeutics. An estimate from Wells Fargo places the potential revenue from this drug at US$600 million per year.
On 31 March 2010, Orexigen submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for this drug combination. On 7 December 2010, an FDA Advisory Committee voted 13-7 for the approval of Contrave, and voted 11-8 for the conduct of a post-marketing cardiovascular outcomes study. Contrave’s PDUFA date was 31 January 2011. Subsequently, on 2 February 2011, the FDA rejected the drug and it was decided that an extremely large-scale study of the long-term cardiovascular effects of Contrave would be needed, before approval could be considered. The recommended daily dose of Contrave is two (8 mg naltrexone/90 mg bupropion) tablets taken twice daily (4 tablets total – 32 mg naltrexone, 360 mg bupropion). Upon initiation, the drug will be started with a quarter-dose (or one tablet) for one week and a pill will be added to the regimen each week until the full recommended dose is reached on Week 4.
Treatment is designed to influence the hypothalamus in order to decrease food intake over an extended period of time. Studies of almost 700 patients, 90% female, ran up to 56 weeks. The control group, overall, lost 5% of their initial body weight, or 11-16 lbs. The experimental (medicated) group lost 20-23 lbs during the same amount of time. The average starting weight for participants was 223 lbs. Current medical weight loss medications average 5-22 lbs lost in 6 months.
W8MD Medical Weight Loss Centers of America is one of the first weight loss programs to start offering Contrave for eligible patients to help lose weight and is available at their weight loss locations in New York, Pennsylvania and New Jersey. Call W8MD today at 1-800-W8MD-007 to learn more or to setup a consultation. As one of the very few medical weight loss centers that accepts health insurance for the physician weight loss visits, W8MD gets patients from far and near including other states!
King Of Prussia Weight Loss & Sleep Center: 987 Old Eagle School Rd, Ste 712, Wayne, PA, 19087 Ph: 215-676-2334
If you are looking for Doctors in New York City that prescribe Contrave, you may want to contact the New York City W8MD medical weight loss center location at 718-946-5500.
NYC Insurance Weight Loss & Sleep Center: 2003, Bath Avenue, Brooklyn, NY, 11214 Ph: 1-718-946-5500.
For those living in New Jersey looking to try Contrave, please contact the W8MD weight loss program will be offered soon 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.