In September 2014, the United States FDA gave the final approval for the new weight loss drug – Contrave, an extended release combination of Naltrexone and Bupropion.
Contrave (referred to as “NB” hereafter), a novel combination product for the treatment of obesity, is composed of bupropion combined with naltrexone.
CLINICAL PERSPECTIVE ON OBESITY AND ITS TREATMENT
Obesity is a rapidly growing epidemic among adults, adolescents, and children in the United States.
Currently, there are three main approaches to the treatment of obesity:
(1) diet, physical activity, and behavioral modification (diet and exercise);
(2) pharmacotherapy; and
(3) nariatric surgery.
Diet and exercise is the mainstay of weight management and generally precedes other measures.
Unfortunately, diet and exercise alone yield mostly limited and transient weight loss, with many individuals finding it difficult to adhere to such regimens.
The strategy to implement pharmacotherapeutic or surgical approaches in addition to diet and exercise depends upon the patient’s BMI as well as the presence of obesity-related comorbidities.
However, unlike the situation for other metabolic diseases such as hypertension and type 2 diabetes, there are very limited obesity pharmacotherapies available.
Although orlistat is approved for long-term use and provides efficacy beyond that usually achievable using diet and exercise alone, it is not tolerated well by some patients.
The other available pharmacotherapies, e.g. phentermine, are approved for short-term use only.
While more invasive options (e.g., gastric banding, bariatric surgery) do result in greater weight loss than is achievable with pharmacotherapy, these are targeted primarily to those patients with the highest BMI.
The benefit of surgery is also offset by greater expense and risk. In the face of such limited options, patients often resort to the use of off-label medications or dietary supplements that may be ineffective or unsafe. In this context, agents such as NB may offer viable alternatives for many obese patients.
Contrave approved for weight loss
Contrave is a combination of two FDA-approved drugs, naltrexone and bupropion, in an extended-release formulation. Naltrexone is approved to treat alcohol and opioid dependence. Bupropion is approved to treat depression and seasonal affective disorder and as an aid to smoking cessation treatment.
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 conditions treated for one year. All patients received lifestyle modification that consisted of a reduced- calorie diet and regular physical activity.
Results of Contrave
Results from a clinical trial that enrolled patients without diabetes showed that patients had an average weight loss of 4.1 percent over treatment with placebo (inactive pill) at one year. In this trial, 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 with 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.
Side effects of Contrave
The most common adverse reactions reported with Contrave include nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea.
Cost of Contrave
Priced at an affordable maximum of $45.00 with insurance to $100.00 without insurance per month with a savings card or $275 per month without savings card, Contrave is probably one of the most cost effective new combination weight loss medications and compares favorably with Belviq and Qsymia.
BENEFIT/RISK OF USE OF CONTRAVE
Key benefits following treatment with Contrave(NB) are summarized below:
- Clinically meaningful weight loss was apparent early in treatment, and was greater than that observed with either naltrexone or bupropion alone. Weight loss was on average sustained, and those patients who continued treatment through 56 weeks experienced the most substantial weight loss. The efficacy of NB was observed across all demographic and clinical subgroups evaluated, including patients with hypertension, dyslipidemia, history of cardiovascular disease, type 2 diabetes, impaired fasting glucose, or history of depression.
- Significant effects of Contrave (NB) treatment were observed on a number of weight-related cardiometabolic parameters (e.g., waist circumference, triglycerides, HDL-cholesterol, and hs-CRP); HDL increases and triglyceride reductions were observed irrespective of history of dyslipidemia or treatment for this condition.
- Patients with type 2 diabetes benefitted from weight loss, improvements in waist circumference, HDL and triglycerides, and clinically significant improvements in glycemic control (particularly decreased HbA1c). A lower proportion of NB-treated patients required adjustments to their antidiabetic medications due to poor glycemic control.
- Greater proportions of Contrave-treated patients reported clinically meaningful improvements in weight-related quality of life compared with placebo, providing further evidence of the range of clinical benefits that can be derived from Contrave treatment.
In summary, the benefits of Contrave outweigh the risks given the clinically meaningful weight loss and improvement in multiple markers of cardiometabolic risk and patient-reported quality of life.
Overall, the Contrave safety profile is well-understood, with known risks that are predictable and manageable via appropriate risk mitigation approaches. Orexigen is developing a plan for additional clinical studies to assess: 1) prescription utilization patterns, 2) physician and patient adherence to labeling, and 3) the impact of Contrave on cardiovascular outcomes.
Locations for W8MD Physicians familiar with Contrave
W8MD Medical Weight Loss Centers of America’s physicians are familiar with this and many other weight loss medications and can offer Contrave as a tool to fight the epidemic of obesity to eligible patients.
Philadelphia Insurance Weight Loss & Sleep Center: 1718, Welsh Rd, Philadelphia, PA, 19115 Ph: 1-215-676-2334
King Of Prussia Weight Loss & Sleep Center: 987 Old Eagle School Rd, Ste 712, Wayne, PA, 19087 Ph: 215-676-2334
2632 E 21st St Brooklyn New York 11235
W8MD weight loss program in New Jersey.
W8MD weight loss, sleep and medical aesthetics
140 E Evesham Rd Cherry Hill New Jersey 08003