$99.00
Are you searching for an effective weight loss solution? Look no further than Mysimba, available at Dr. Bruce Reborn Pharmacy. This powerful medication can help you achieve your weight loss goals and regain control of your health and well-being.
Mysimba is a prescription weight loss medication that combines two active ingredients, naltrexone and bupropion, to target multiple areas of weight management. It works by reducing cravings, suppressing appetite, and increasing energy levels, all of which contribute to successful weight loss.
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Mysimba weight loss tablets are a prescription-only medication. They can help you lose weight by reducing your appetite, so you feel more full after eating less food. This helps you to follow a diet and exercise regime and to lower your calorie intake without feeling hungry.
Mysimba diet pills are taken every day, starting with 1 pill each morning. Your Mysimba dosage is increased over 4 weeks, to reduce the risk of side effects like nausea (feeling sick). You should start to see Mysimba results within a few weeks of starting treatment.
You’ll get the best results by exercising regularly and eating well while taking Mysimba tablets. You can buy Mysimba online from regulated online doctor services, .
The European Medicines Agency (EMA) has initiated a review of the weight management drug Mysimba following concerns regarding its potential long-term cardiovascular safety.
What is Mysimba?
Mysimba is a weight loss medication consisting of 7.2 mg naltrexone and 78 mg bupropion as active substances. It is a prolonged release tablet that is taken orally.
How is it different from other weight management drugs?
Currently, many type 2 diabetes medications, such as tirzepatide, liraglutide, and semaglutide, are approved for weight management in people who are obese or overweight. These medications induce satiety, which enables people to eat less food and feel fuller for longer.
On the other hand, naltrexone, an active substance in Mysimba, is an opioid antagonist indicated for the treatment of alcohol or opiate dependency. Bupropion is a weak inhibitor of neuronal dopamine and norepinephrine uptake and is approved to treat depression or help in smoking cessation. When used together, these two drugs are meant to have an impact on the area of the brain that manages energy levels and food intake, as well as lessen food cravings.
Weight management with Mysimba
Mysimba is indicated for the purpose of weight management together with a reduced-calorie diet and physical activity in adults who have obesity or are overweight and have one or more weight-related comorbidities like type 2 diabetes, dyslipidaemia, or high blood pressure. Patients start treatment with one tablet a day and the dose can be gradually increased to two tablets twice a day. The treatment should be stopped if patients fail to lose at least 5% of their initial body weight after 4 months of Mysimba therapy.
EMA’s approval of Mysimba
The EMA had granted marketing authorisation to Mysimba in December 2014 based on positive results from four multicenter phase 3 trials, which included 4536 individuals who were obese or overweight and were randomly assigned to receive naltrexone plus bupropion or placebo, both in conjunction with lifestyle modifications. In three of these studies, percentage of weight loss was greater (3.7%-5.7% vs 1.3%-1.9%), and a higher proportion of subjects lost ≥5% of their total body weight (28%-42% vs 12%-14%) with naltrexone-bupropion combination vs placebo, demonstrating the superior efficacy of Mysimba. The overall weight loss was more promising in the fourth study.
Safety profile
The most common adverse events associated with Mysimba treatment are nausea, constipation, vomiting, dizziness, and dry mouth; however, they are mostly manageable. Additionally, the use of Mysimba was discouraged in people who have severe renal or liver disease, uncontrolled high blood pressure, have ever experienced a seizure, are going through alcohol or drug withdrawal, have specific psychiatric issues, or have brain tumours.
Why is Mysimba under review?
In the phase 3 studies, Mysimba vs placebo increased the transient relative blood pressure by ~1-2 mm Hg and the heart rate by ~1.5 beats per minute. Also, according to data from clinical practice, other bupropion-related drugs have been reported to cause severe episodes of hypertension that have required acute treatment. This concern about the effect of Mysimba on cardiovascular outcomes was noted by the Committee for Medicinal Products for Human Use (CHMP) at the time of review.
Soon after, interim results from the LIGHT trial showed no increased risk of cardiovascular events with naltrexone plus bupropion vs placebo in the short-term. However, the results were not sufficient to assure physicians about the long-term cardiovascular safety associated with Mysimba.
A second study, CONVENE, designed to monitor the medicine’s cardiovascular effects, was prematurely terminated by the marketing authorisation applicant, Orexigen Therapeutics.
Since then, Orexigen has proposed several study designs, including a phase 4 study and a retrospective database cohort study. The CHMP, however, did not endorse these studies and considered them insufficient to generate long-term cardiovascular safety data. To date, there is no suitable study plan that can outline a clear benefit-risk profile of the medication, and the issue regarding the long-term cardiovascular safety connected with Mysimba looms large.
