The FDA approved another new weight loss medication, Contrave which is a combination of Bupropion and Naltrexone in extended release formulation for the treatment of obesity and weight management, including for weight loss and maintenance of weight loss, used in conjunction with lifestyle modification. Obesity is a rapidly growing epidemic among adults, adolescents, and children in the United States. 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. All four Phase 3 studies showed statistically significant improvement in each co-primary endpoint relative to placebo. Patients may experience elevated blood pressure or pulse during Contrave treatment; the risk may be greater during the initial 3 months of therapy.
All four Phase 3 Contrave studies demonstrated statistically significant and clinically meaningful weight loss following up to 56 weeks of treatment with Contrave compared with placebo. The average percent weight loss from baseline observed with NB treatment across the four studies corresponded to between approximately 5 and 9 kg (11 to 22 pounds).
Patients with type 2 diabetes in Contrave Study showed the smallest degree of weight loss, although a significantly greater proportion of Contrave-treated patients benefitted with at least 5% weight loss at endpoint compared to placebo. Clinically meaningful weight loss was apparent early in treatment, and was greater than that observed with either naltrexone or bupropion alone. 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). Greater proportions of NB-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 NB treatment. The use of NB was generally well-tolerated, with the frequency and distribution of safety findings being consistent with the established profiles for naltrexone and bupropion. Common AEs such as nausea and vomiting tended to occur early in treatment (during the dose-escalation phase), were mostly mild to moderate in severity, and were generally self-limiting. The incidence of treatment-emergent SAEs overall was low; the vast majority of SAEs in NB-treated patients were considered unrelated to study drug. Initiation of treatment with NB was associated with transient increases from baseline of approximately 1 mm Hg in mean blood pressure, followed by small reductions below baseline.
The incidence of major cardiovascular events (cardiovascular death, myocardial infarction and cerebrovascular accident) and revascularization procedures were low and comparable between NB- and placebo-treated patients, although the number of events is too low to draw firm conclusions. Seizures occurred infrequently at a rate that is consistent with that observed for the lowest approved dose of bupropion SR.
Treatment with NB in the target patient population does not appear to be associated with an increased risk for depression or suicidality. Clinical laboratory evaluations were generally unremarkable, and values outside of normal ranges tended to be sporadic and unrelated to dose. Neither bupropion nor naltrexone has historically been associated with prolongation of QTc intervals, and review of QT, QTc and the other ECG parameters in patients during long-term NB treatment revealed no noteworthy findings.
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The distributor of Contrave, Takeda Pharmaceuticals has a program called Scale Down which provides a smart scale that interacts with your smart phone by sending your weight loss progress to your smart phone with customized messages to suit your needs and is included free when you activate the contrave complete discount card! In summary, the benefits of NB 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 NB safety profile is well-understood, with known risks that are predictable and manageable via appropriate risk mitigation approaches.
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In the spirit of successful drugs like Phentermine, which was removed from the market back in 1996. However, Contrave warning labels caution patients to be aware of suicidal thoughts while encouraging emergency medical attention!
Prescription required – It can’t be purchased online and can only be prescribed through your doctor. Moderate – most Contrave users agree about the massive side effects they get from Contrave –  this point affected the overall user ratings massively. RDK Global, they are the manufacturer and distributor of top selling weight loss and pain relief natural supplements. Bupropion has caused some people to have suicidal thoughts or actions or unusual changes in behavior, whether or not they are taking medicines used to treat depression.


The amount varies, but on average, people lose 5% to 10% of their starting weight, according to clinical trials and experts. In one 56-week study looking at Contrave combined with health habit changes, those on the drug lost more than 9% of their starting weight, while those on placebo lost just 5%. So a 200-pound person losing 10% would end up at 180 pounds, perhaps moving from the obese to the overweight range, or the overweight to the healthy weight range. If Contrave does not work after 12 weeks, the FDA says its use should be stopped.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. Only helps users to lose 5% of body weight in 14 months (you should lose more than that on your own). There’s no weight-loss cure that eliminates the need for diet and fitness— and it is important to stress that any weight loss pill must be paired with healthy behavior.
The company resubmitted its application in December of 2013 citing encouraging result in the 8900 patient study that is ongoing. The obesity epidemic was well known, but medications to treat obesity have minimal long-term effectiveness and are costly. To put this into some perspective: it is minimally more effective as Belviq, which is not recommended by Consumer Reports.
The second part of this drug is a medication called naloxone which on withdrawal of the drug has side effects including feeling nervous, body aches, dizziness, diarrhea, runny nose.
Contrave combines two drugs: bupropion (Wellbutrin), an antidepressant, and naltrexone, an anti-addiction drug.
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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 most commonly reported side effects (those that occurred at a ?5% incidence in the Total NB group and greater than the incidence in the placebo group) for patients treated with NB are displayed in the table below. Weight loss was on average sustained, and those patients who continued treatment through 56 weeks experienced the most substantial weight loss. A lower proportion of NB-treated patients required adjustments to their antidiabetic medications due to poor glycemic control. These increases are consistent with the known hemodynamic effects of bupropion and were attenuated by weight loss in patients who responded to therapy, although mean blood pressure reductions with NB were always less than that observed with comparable placebo patients.
Bupropion has been extensively prescribed since its original approval more than 20 years ago, and has a long history of safe use even in populations considered at risk for CV disease. These benefits in aggregate are expected to be greater in general clinical practice, as proposed labeling would lead to discontinuation of treatment for patients not experiencing at least a 5% decrease from baseline in body weight.
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.
Tumpati, I can't thank you enough for helping transform my daughter Erin (lost 64 lbs*) into a much happier young lady and she looks amazing and also thanks for helping me lose 25 pounds I feel great - Lisa, Erin's mom. W8MD medical weight loss website or any of our affiliated weight loss blogs is not intended to diagnose, treat, cure, or prevent any disease. Huge flow of pharmaceutical producers decided to act by providing another prescribed weight loss drug to take the lead of Phentermine.
All their products are manufactured in FDA-approved laboratories in the United States and the European Union.
This drug inhibits the reinforcement of addictive substances by blocking opioid receptors to the brain. Bupropion may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. But, to take advantage of the lowest cost available to you, there are certain pharmacies that will mail Contrave to you at a discounted price. Phen375 proved for the last 6 years that it had change lives through its fat burning mechanism.
You will likely get impatient, but more the dedication in exercise and healthy diet along with a safe diet pill will certainly change your lifestyle to a whole new level.
Terry Simpson Two years ago the FDA rejected Contrave, a weight loss medication, because of a lack of long term data for this drug that is, at best, minimally effective for weight loss. There has never been a study showing that taking these drugs lowers the risk of heart attacks or strokes (the major cause of death among obese individuals).
One of those drugs is Wellbutrin (Bupropion) which is used for treatment of mood disorders. The naloxone has side effects such as abnormal heart rate and rhythm, trouble breathing, cardiac arrest, fluid in the lungs, and diarrhea. The changes in lifestyle for diet and exercise still remain the safest, best, and only long term solution.
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The bupropion helps lessen appetite while the naltrexone works by blocking certain receptors in the brain and curbing cravings. Achieving 5% weight loss is not only an FDA guidance efficacy benchmark, but this degree of weight loss is known to confer significant cardiometabolic benefit. As patients with hypertension or a history of hypertension may be at increased risk of blood pressure elevations, care should be exercised when initiating treatment with Contrave in such patients. 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. The small elevations in heart rate seen with NB treatment (compared with decreases with placebo) are also consistent with known bupropion effects. Benefits are observed across a range of overweight and obese patient subgroups and in various treatment settings.
So far I have lost 42 pounds with 18 to go before by youngest daughter's 21st birthday trip to Hawaii.
I would highly recommend him to anyone that is serious about not only losing weight but improving their overall health , gaining knowledge about their bodies and nutrition and developing a healthier lifestyle. Serious side effects of this drug include chest pain, rapid and irregular heart beat, rise in blood pressure, confusion, seizures, hallucinating, irrational fears.
Terry Simpson received his undergraduate and graduate degrees from the University of Chicago where he spent several years in the Kovler Viral Oncology laboratories doing genetic engineering. 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. Of note, the population of patients receiving currently approved bupropion-containing therapies has important similarities to patients enrolled in the NB clinical program, as well as the population of patients who receive currently marketed obesity pharmacotherapy.
Always consult with a healthcare professional before starting any diet, exercise, or supplementation program, before taking any medication, before starting any treatment program or if you have or suspect you have a health problem. However, It seems Orexigen Therapeutics (Contrave producers) fought a big war to earn that FDA approval for the Contrave weight loss pill. More common side effects include agitation, dry mouth, constipation, headache, nausea, insomnia, blurred vision, and many others. In this context, agents such as Contrave, a combination of Naltrexone and Bupropion(NB), may offer viable alternatives for many obese patients.
In addition, clinical experience and investigation in relevant patient populations, including those with cardiovascular risk factors or established cardiovascular disease, have not identified specific safety signals for clinical cardiovascular events.
Some information, products and claims on this website have not been evaluated by the United States Food and Drug Administration (FDA) and are not approved to diagnose, treat, cure, or prevent any disease.
The bupropion helps lessen appetite, says William Troy Donahoo, MD, an endocrinologist and weight loss specialist at Kaiser Permanente, Denver. The story with Contrave is still new and we did as much as possible to provide user reviews.
The naltrexone, he says, probably works by blocking certain receptors in the brain and curbing cravings.
We prefer safety over health risk and even if Contrave has powerful weight loss effect it is still unsafe along with its highly addictable ingredients.
These question will be answered later in this research but first we would like to run a brief comparison between Phen375 and Contrave. As Phen375 is one of the leading top selling weight loss pill taking it as a reference will provide a clear points to compare from. Naltrexone (on the market since 2004) is an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid dependence. It is marketed in generic form as its hydrochloride salt, naltrexone hydrochloride, and marketed under the trade names Revia and Depade. However, the weight loss is modest.When these two medications are combined together, the weight loss increases by a factor of at least 4-5. Similar to Belviq, there is very little insomnia or stimulation as is seen with most other weight loss medications. For those with an element of depression and obsessive eating and cravings, Contrave may be the answer. Since it’s composed of older drugs with proven safe track records, safety is not an issue. Also, unlike most weight loss drugs, Contrave will be marketed as a non-controlled drug.To make an appointment, call us at 305-670-3259Contrave, Qsymia or Belviq: Which is the Best New FDA Approved Weight Loss Medication?
Contrave, Qsymia, and Belviq each have entirely different mechanisms of action, weight loss efficiency, and side effects, allowing you to individualize your weight loss experience by enhancing the benefits while minimizing the side effects. If you have 20, 30, 50, or even 100 pounds or more to lose, like 100 million other Americans, these medications may be for you.



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