Medications for the treatment of obesity in the European market. Withdrawn and available
The European market of pharmaceuticals for weight reduction continues to develop in a dynamic manner. As of today, the choice of anti-obesity pharmacotherapy for overweight Europeans is not very diverse. However, doctors can select a medicine that will be effective in reducing weight for each individual patient.
If we talk about the history of the pharmaceutical treatment of obesity in Europe, we can divide all slimming drugs into four groups:
- Used earlier, and withdrawn from sale for security reasons;
- Considered by the European Medicines Agency (EMA) as promising drugs to fight excess kilograms, and never received a marketing authorization;
- Currently used;
- Approved by the EMA and awaiting their appearance on the pharmaceutical market.
Medicines that were previously used in Europe for the treatment of obesity, and are no longer sold in pharmacies – are the sympathomimetics Rimonabant and Sibutramine. They are drugs of central action and at various times have enjoyed some degree of popularity in the treatment of obesity in overweight patients.
Among all the weight loss drugs, Rimonabant had the shortest term of a marketing license. The drug under the trademark Acomplia obtained a marketing authorization in the European countries in 2006. Two years later, the production of the drug was stopped because of the increased frequency of reports of mental side effects after its use.
Sibutramine, which was approved in Europe in 1999, was the most promising weight loss drug and was considered a completely safe medicine. However, with every year of Sibutramine use in the clinical practice of obesity treatment, more and more evidence has been accumulating that the drug increases the risk of cardiovascular pathologies.
Based on the results of clinical trials, the EMA has concluded that the benefits of using Sibutramine in treating obesity do not exceed the potential risks. Therefore, the drug was withdrawn from sale in 2010.
If Rimonabant and Sibutramine were used for a while in Europe for weight loss, Lorcaserin and Qsiva did not receive a marketing authorization at all. In 2012, the EMA rejected the request by Vivus Company on the approval for sales of the combined weight loss drug Qsiva (Phentermine / Topiramate) in Europe. Clinical trials have shown that Qsiva use increases the risk of cardiovascular side effects.
In 2013, another slimming drug – Lorcaserin – suffered the same fate as Qsiva did. The EMA rejected the application of Arena Pharmaceuticals (Lorcaserin manufacturer) for the marketing authorization in Europe. The EMA referred to an inadequate number of clinical trials that would confirm the efficacy and safety of Lorcaserin in weight reduction.
However, the ban on Lorcaserin sales in Europe is not final. If clinical trials will be held in the near future and the safety of the drug in weight reduction is confirmed, the EMA is ready to consider a new proposal for marketing authorization for Lorcaserin in Europe.
Rimonabant and Sibutramine are not the only sympathomimetics that were used in Europe for weight loss. Phentermine appeared on the European pharmaceutical market in 1991 under the trademark Adipex Retard.
The medicine for fighting excess kilograms was used by the residents of Poland, Hungary, Austria and other countries. In 2006, however, many countries of the European Union imposed a ban on the sales of Adipex Retard because of the high risk of drug dependence.
At present, the Czech Republic remains the only European country, in which phentermine-containing drug Adipex Retard is still sold and used. During the period of 1991 to 2017, the maximum allowable single dose of Phentermine was 30 mg. But recently, based on the decision of the Czech government, each Adipex Retard capsule can contain no more than 15 mg of the active substance.
While all these weight loss drugs have a pronounced effect on the brain and the central nervous system, Orlistat acts exclusively in the gastrointestinal tract. The lack of systemic impact makes Orlistat a safe and effective anti-obesity medicine.
In contrast to other drugs for weight loss, which are sold in conventional pharmacies only on prescription, Orlistat can be bought both with a medical prescription and without it. Depending on the availability/absence of the medical prescription, the patient can buy:
- Alli (over-the-counter)
- Xenical (prescription)
Orlistat is available for sale in almost all countries in Europe for a long time. However, people can also find medications for obesity, which appeared on the pharmaceutical market recently, but continue gaining popularity among obese patients every year.
Once Sibutramine was off the market in 2010, Phentermine was the only central-action drug in Europe for the treatment of obesity for a while. In 2015, however, the European Medicines Agency (EMA) authorized sales of Mysimba in Europe. It is a combined drug, based on Naltrexone and Bupropion.
Pharmaceutical company Orexigen obtained a marketing authorization for the sale of Mysimba in Ireland on March 26, 2015, and on August 1, 2016 in Spain. In the near future, the appearance of the combined weight loss drug is planned in the UK and other countries of the European Union.
Almost simultaneously with Mysimba, the EMA granted a marketing authorization in Europe for another weight loss drug – Saxenda (Liraglutide). However, Saxenda has not yet been launched for sale in any of the countries of the European Union. In the near future, this drug is expected to appear on sale in pharmacy chains. Currently, Europeans can buy Saxenda online.
At present, the European pharmaceutical market continues to develop dynamically. The search continues for medicines, which can take a worthy place among drugs for the treatment of obesity.