New Diet Drug Candidate May Boost Weight Loss Rates


October 22, 2008

-         NeoroSearch S/A   -

Recent clinical studies on the experimental new diet drug, called tesofensine, showed that its effectiveness may surpass the average weight loss rates, ensured by any of the currently available diet pills. While existing diet pills may help a patient reach up to 11 pounds (about 5 kg) weight loss rate provided that the therapy is combined with proper dieting and intense exercising, tesofensine may practically double that result, offering up to 28 pounds weight loss.

Tesofensine is a new drug candidate, which is developed by the Danish biopharmaceutical company NeuroSeach A/S. For the time being, the researchers have already completed phase II clinical studies, and have already started the preparation for the final stage of the studies before submitting new drug application to the regulatory agencies. The phase III clinical studies are expected to start at early 2009.

In general 140 obese people participated in the recent study, called TIPO-4. All of them had already been treated with tesofensine in different doses, ranging from 0.25 mg to 1 mg of the medication per one day, during the previous TIPO-1 clinical study. During TIPO-4, all the participants received 0.5 mg of the medication per day. In addition to this, the participants were asked to follow a restricted diet and increase their daily exercising routine.

After summarizing the data from both parts of phase II clinical studies, the researchers confirmed that people, who were treated with placebo during TIPO-1 study and with tesofensine during TIPO-4 study, achieved about 9 kg of weight loss. Those patients, who were treated with the medication during both parts of the experiment, achieved even better results: up to 13-14 kg of weight loss.

In addition to such amazing results on weight loss, the researchers say that all the conducted studies on tesofensine showed that the medication is generally well-tolerated over extended periods of administration. The most frequently reported side effects, associated with the treatment, were dry mouth, insomnia, and gastrointestinal disorders.

However, it is the potential of adverse reactions, which raises certain disputes referring the new diet drug. Medical experts are especially concerned about the increase of blood pressure in patients, treated with tesofensine. Besides, some cases of the increased anger, hostility and confusion were also reported. It is necessary to admit here, that all the above mentioned serious side effects were associated with higher doses (1 mg per day) of the medication.  

Obviously, the incidence of specific psychological side effects can be explained by the mode of action of the new diet pill. The key is that tesofensine works in human brains, interacting with three neurotransmitters, namely dopamine, noradrenaline and serotonin, which are known to take part in functioning of the specific brain centers in human, responsible for appetite, pleasure and metabolism.

Stimulating the release of dopamine, the medication “artificially” creates a pleasure-feeling of food. In simple words, with the diet pill the feeling of satisfaction appears much sooner than without it. Besides, tesofensine affects hypothalamus in order to suppress appetite and increase metabolism.

Finally, it is interesting to note that tesofensine was initially researched as the medication to treat Parkinson’s disease and Alzheimer’s disease. During the initial trials the researchers saw low effectiveness of the medication in the treatment of the said conditions. However, at that time the scientists also noted the significant weight loss in patients treated with tesofensine. Since then, the researches focused their attention at the tesofensine as the diet medication. Once the future trials prove the effectiveness and safety of tesofensine, the medication will be submitted for approval by official medical authorities.

Nick


External resources
http://www.neurosearch.com/Default.aspx?ID=118
http://en.wikipedia.org/wiki/Tesofensine
http://www.rxlist.com/script/main/art.asp?articlekey=93645


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