New anti-obesity drug wins European approval
The European Medicine Agency (EMA) has finally authorised a
controversial anti-obesity drug as a weight loss aide
for overweight patients with plans to release it this year.
The approval came after the completion of four crucial clinical tests into the safety and effectiveness of the drug, Mysimba, which was sanctioned by the EMA for medical use throughout the European Union in March 2015.
The supplement, from American company Orexigen Therapeutics, is branded an anti-obesity drug to help combat the continuously increasing problem of seriously overweight or obese people when taken alongside a calorie-controlled diet and exercise regime.
However, the presence of a potent anti-depressant in Mysimba and its subsequent safety risks has caused great debate in the medical community regarding the supplement’s possible adverse effects on mental health.
Mysimba will only be available on prescription for people with a Body Mass Index (BMI) of 30 kg/m2 or greater. However, people with a BMI of 27 kg/m2 to hypertension, type-2 diabetes or high cholesterol to qualify. The treatment of ailments and illnesses connected with obesity can be extremely costly, so experts are constantly looking for new ways to help tackle this debilitating issue.
What is Mysimba?
Mysimba is a new brand name for a drug that has been approved and available on the American market since it won US approval in September 2014. It’s developed by Orexigen Therapeutics, which is a biopharmaceutical firm that was founded in 2002 and is based in California, USA. The company claims to specialise in developing treatments for obesity, but its initial version of Mysimba, called ‘Contrave’ in the USA, is its only product to date.
How does Mysimba Work?
Mysimba will be a prolonged release tablet, which means its effect is delivered over an extended period of time. It influences two, key parts of the consumer’s brain: one that is responsible for energy expenditure and another that controls food intake. However, it is also reported to impact on the “reward” senses associated with eating, which would arguably have extra effect on the user’s feelings towards dieting and cravings.
What’s in Mysimba?
Interestingly, Mysimba contains just two active ingredients: the antidepressant bupropion and Orexigen Therapeautics’ formula of naltrexone, which is primarily designed and distributed to fight drug dependency.
Bupropion is popularly used to treat depression, seasonal deficit disorder (SAD) and even as an aide to stop smoking, which it does by influencing chemical activity in the brain. It is traded under many different brand names, including Wellbutrin and Zyban, and is considered an effective method of treatment. However, the major safety caution that comes with taking this substance is the risk of suicidal thoughts, although the likelihood of arriving at this mental state is unclear. There is also a range of other, less extreme side effects attached to its ingestion. The most common are anxiety, irritability, shaking, irregular heartbeats and trouble sleeping, but it might also cause severe headaches skin rashes and ringing in the ears. Consequently, the American version of Mysimba comes with a stern health warning, which includes advising those with a mental illness, eating disorder or high blood pressure not to take it.
Naltrexone is a common form of medication that falls into a category called opiate antagonists. It supposedly works by lowering the user’s craving for drugs or alcohol and stopping their effects, which should subsequently result in decreasing the consumer’s level of substance dependency. However, naltrexone also carries a health warning, although arguably not as severe as bupropion’s. Experts advise that people suffering from hepatitis or liver disease should avoid it, as the primary concern of naltrexone is that it’s believed to cause damage to this organ after large doses are taken.
Testing and Trials
Being released under the brand name Contrave in the USA, Mysimba is not completely new to the supplement market and several trials have been conducted on it. Generally, many agree that it is effective on the condition that it’s used alongside a calorie-controlled diet and exercise routine, although this arguably detracts for the independence of its success.
Approximately 4,500 overweight people have been used in a variety of Contrave clinical trials. The overall results showed that 42% of those taking the supplement lost a minimum of 5% of their body weight, whereas experts from another trial that included patients with type-2 diabetes reported a weight decrease of at least 5% in 36% of its subjects.
The Food and Drug Administration (FDA) put certain stipulations in place to control the use of the drug, including the guideline that those taking Contrave should be assessed after three months of taking the supplement to determine if it’s successful. According to the FDA, a patient must lose a minimum of 5% of their body weight to be considered a successful consumer.
The agency also states it requires future trials to establish the possible cardiovascular risks of taking Mysimba/Contrave, since this health hazard is also a crucial concern. Other demands include an assessment of the drug’s safety and effectiveness in pediatric patients, as well as an examination of the possible adverse interactions it might cause when used alongside other medication.
Arguments against Mysimba
Many health professionals are in favour of Mysimba, but some are less supportive of its EU approval. The weight loss experienced by past consumers isn’t necessarily significant or guaranteed, so many people think that the health risks of taking the supplement far outweigh the benefit of losing a few kilograms of body weight.
It’s also argued that some users have regained their lost weight once they stopped taking Contrave, although there aren’t any scientific statistics to support this idea. The detrimental effect it might cause on the mental stability of its consumer, currently unknown long-term effects and overall implications of using an established antidepressant for weight loss has caused many to doubt its dependability.
Reassuringly, there doesn’t seem to be any reports of serious outcomes since its release on the American market so far.
Future of Mysimba
Mysimba appears to be a sturdy aide to help combat the growing issue of obesity and prevent the plethora of medical ailments that it causes. Experts believe its main side effects might be connected to the central nervous and digestive systems. However, there’s a cardiovascular trial currently running that appears to be providing positive results so far in regards to Mysimba’s safety.
The European Medicines Agency are recommending that future consumers of Mysimba be evaluated after 16 weeks of the drug and its use stopped if 5% of their body weight is not lost. Crucially, all users must use the supplement in conjunction with a healthy diet and exercise routine for it to work effectively.
A decision on its price has yet to be decided, although this will vary between each member of the European Union depending on its use in that particular health system.
Overall, the approval of Mysimba as a component of fighting obesity and its subsequent ailments seems to have been met with mixed feelings. There are multiple clinical trials to support its success as a weight loss aide that have been conducted on thousands of overweight patients, which backs its effectiveness to a certain degree. However, the extremity of its possible side effects, notably the suicidal thoughts and cardiovascular implications, makes some people question whether the weight loss is worth the risk.
Overall, only time will tell how effective the drug is and whether it can truly make a difference to Europe’s obesity level.
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