Your informational guide to Tesofensine
Tesofensine is a new experimental weight loss drug shown to have outstanding weightloss properties beyond that of existing weighloss medications. NeuroSearch is the Danish Pharmaceutical company currently testing this product. Tesofensine is the generic name and to date there has not been a trademarked name associated with it. Technically, it is a serotonin-noradrenaline-dopamine reuptake inhibitor. This means it influences these chemicals in the brain to suppress ones appetite, or make one feel full. There is still more testing that must be done before it would ever be made public, but what this means to millions of people worldwide is a pill offering huge potential in the fight on obesity.
It is interesting how medications can be developed for one thing but then after being tested for certain ailments be found to take on other beneficial issues. This was the case with Tesofensine. It was developed with the treatment of Parkinsons and Alzheimers in mind. But early testing of the product for these deseases found to be limited in effectiveness for them. But what they did find is that tesofensine produced remarkable results in weightloss. Researchers then put together a test involving volunteer patients from several Danish obesity management facilities and tested the medication strickly as a weightloss medication. Of the test group, 143 where women, the rest men, and all aged between 18-65. Of the people in the test, there where 4 groups where one was a placebo group and the other members received different amounts of the medication. Altogether, 161 people finished the trial, and the other 42 dropped out for any reason. But was was noticed is that more people dropped out of the 1.0mg group.The results where very substainial.
Early trial results showed that weightloss over the 6 month testing period proved to be more effective compared to any existing weightloss drug. The patients where put on a lower calorie diet and where made to exercise upto an hour per day. Patients where found to have lost an average of 12.8 kg or approximately 28 lbs or 10.6% of their body weight on the 1mg dosage and still a remarkable 11.3kg or approximately 25 pounds on the 0.5mg dose or 9.2% of their bodyweight. The 0.25mg dose group lost average lost was 6.7kg or 14.7 pounds or 4.5% of their body weight. The placebo group lost 2.2kg on average or approx 5 pounds or 2% of thier bodyweight.
What makes this drug's potential so great is that even at a very small dose, it still was able to compete with diet medications currently available on the market (or once where on the market). And with a small dose, comes less side effects than the larger dose.
Later results that where released in Oct 2008 showed that tesofensine worked twice as well as previously publised information on sibutramine (existing diet drug) and Rimonabant, which was recently pulled from the European market due to side effect concerns. Rimonabant was never accepted in the United States for that very reason of side effect concerns including suicidal and psychological issues such as depression. Yet dispite a few reported side effects such as dry mouth, constipation, insomnia, gastrointestinal tract issues, no reported suicidal thoughts where observed with tesofensine which is a huge plus over Rimonabant. Also noted is that tesofensine had double the weightloss in tests over its competitors and apparently this medication has found to not affect blood pressure at the 0.5 mg dosage and only to raise ones heart rate slightly. Infact, there have not been major problematic side effects reported and if these tests continue to hold up, there may be not much preventing it from being approved.
As more testing goes forward with this medication it will be made clear as to percieved risks associated with it. It should be noted that the preceding information came from a relatively small test group (203) and more testing needs to be done to ensure its safety and effectiveness. Phase 2 testing of new drugs are important in determining if future testing need be done, but they do not provide information on long term outcomes so Stage 3 tests will provide a much clearer picture of the drug.
NeuroSearch plans on on stage 3 trials in early 2009 which depending on the results could then apply for regulatory approval.
With so much of the country being overweight if we had something that was truly effective, not only could it help out the individual, but also health care as obesity is linked to other health related illnesses such as heart disease and diabetes. Tesofensine could even lessen the need for gastric bypass surgery. If all still proved to be good, tesofensine could be three years before it makes it to the market.
March 31st 2009
There will be a meeting between NeuroSearch and the FDA regarding this medication for the treatment of obesity in the second quarter of 2009 and later in 2009 with EMEA. (European Medicines Agency) The details of the stage 2 trials along with other clinical studies preformed in 2008 will be presented. This will then determine NeuroSearch's details for the important phase 3 program along with a plan for the development of the drug.
May 8th 2009
At the European Congress on Obesity (ECO) it was reported that 1mg of Tesofensine taken for 7 days led to a suppressed appetite and thus decreased caloric intake. Lead author Anders Sjödin, MD, DrMedSci, Department of Human Nutrition, University of Copenhagen presented the findings. He said "tesofensine had a robust effect on suppressing appetite, which likely resulted in reduced calorie intake." and "the weight-reducing effect of tesofensine is mainly caused by it decreasing appetite, but probably also to some extent by its stimulation of thermogenesis." and also mentioned that the drug "resulted in weight loss despite efforts to maintain body weight."
The study was with 32 overweight/ obese men. The test was as follows: Everyone received 2mg for 1 week then half where given a placebo and the other half 1mg for 1 more week. Each patient did light periods of activity but otherwise behaved sedentary during the testing. 1.8 kg on average was lost with the group taking the full 2 weeks on tesofensine as compared to just the 1 week on tesofensine and 1 week on a placebo. The study was funded by Neurosearch.
May 13th 2009
A study that was presented at the 17th European Congress on Obesity (ECO) showing that Tesofensine has minimal to no recreational abuse potential. Some diet medications increase dopamine levels when being taken and therefore can be potentially abused. Kerri Schoedel PhD mentioned "the abuse-related effects of tesofensine were lower than d-amphetamine on most measures."
The study consisted of 44 people between the ages of 18 to 55 years old 77% of which where male and 82% of the subjects where Caucasian. The subjects also had a history of varying kinds of recreational pharmaceutical stimulants. To start each patient received one of either d-amphetamine, bupropion, atomoxetine or a placebo. Then after this patients where given either 1mg, 6mg, 9mg of tesofensine or a placebo to compare the second part of the test with the first. What was found to be noteworthy is that none of these doses of this trial medication had any significance with regards to a" high" or euphoria/ stimulation. The low abuse potential is a great positive for this trial medication.
June 9th 2009
Well it looks like NeuroSearch will be going ahead with Phase 3 for tesofensine. Phase 2 trials where officially finalized with the FDA, as well they have approved of the Phase 3 trials. The proposed dose will be either 0.25mg or 0.50 mg taken daily in the upcoming trials. The tests to come will consist of 4 placebo-controlled studies. Approximately 5700 obese people will take part. Some having other ailments, while others not having other ailments.
November 23rd 2009
It seems that NeuroSearch is having a few difficulties finding a partner with Tesofensine. Due to Tesofensine's chemical similarities with Sibutramine, there is perhaps speculation that Tesofensine may also have some unforeseen cardiovascular risks associated with it. But this is simply speculation, and should only be treated as such. It may also be fair to say that other companies want to see more testing done with this trial medication before willing to partner up with them in Tesofensine's development. And although Tesofensine may have a similar composition as Sibutramine, it is also different, and studies have shown that it more effective than Sibutramine and at lower doses. This is a big plus for it. NeuroSearch is considering opening 4 Phase III studies with at least one study specifically going head to head with Sibutramine. This is good planning for NeuroSearch as it will show the FDA that it has done all it can to uncover any hidden side effects or lack there of and also show how effective Tesofensine is. Stay tuned.
March 10th 2010
It has been reported that Neurosearch is planing for its first phase 3 study of its obesity treatment tesofensine could be initiated in 2010.
May 18th, 2010
There was a test done with Tesofensine published in the International Journal of Obesity and the results where published today. The objective was to examine the means of weight loss by measuring energy expenditure and hunger sensations in the overweight.
The test consisted of 32 overweight men that where given 2 mg of Tesofensine on a daily basis for one week, then part of the group was given a placebo daily for a week after and the other part was given 1 mg of Tesofensine daily for one week after. They also where to maintain there regular food intake and physical activity. What was measured was their energy expenditure, fat oxidation, body composition by dual-energy X-ray absorption, appetite and spontaneous physical activity in a respiration chamber before and after treatment. The results: Although their efforts to keep their body weight and other factors constant, Tesofensine caused an almost 4 pound weight loss above the placebo after two weeks. Tesofensine also caused a high rating of hunger satisfaction and thus lower food consumption than the placebo group. There were no major changes in the 24hour energy expenditure, but higher energy expenditure was noticed at night. Tesofensine also increased the 24 hour fat oxidation rates.
August 25th, 2010
During NeuroSearch's interim report for company affairs their product Tesofensine was mentioned. They stated that a new phase III plan is being prepared and should be ready to be discussed with both US and European regulatory authorities in the last quarter of 2010. They are also in discussion with potential partners while seeking to sign a licensing agreement before the start of the phase III trial.
November 18th, 2010
Neurosearch, announced today that it will be waiting until it finds a partner to help develop their obesity drug Tesofensine. They have been in talks with some companies regarding this. Until this has happened they will not be investing more money into the research of it. Currently they are planning out a modified plan for the phase 3 testing. They plan on meeting with the supervisory body of both the United States and the European Union within the first half of 2011.
May 26th, 2011
NeuroSearch reported today that it has received feedback from the FDA (Food and Drug Administration) and the EMA (European Medicines Agency) regarding the development of Tesofensine. As a result, NeuroSearch has decided that a phase 3 program including two obesity studies of one year each is the best way to proceed. This phase 3 program must also include a study for more than a two year period in order to determine the drug's cardiovascular safety profile. This particular two year part of the testing requires between 5 and 7 thousand patients. NeuroSearch will not go the studies alone but is looking for a partner in helping them develop it.
Check back here for the latest news and findings.
Tesofensine is the generic name given to the trial medication from NeuroSearch. It is currently being tested to fight obesity.
Chemical Make Up