The Danish bio pharma company, Neurosearch, will not seek to develop tesofensine, the obesity drug, by itself and instead seeks a partner in order to continue development with a view to eventually getting it on the market following the guidance of the FDA and EMA in the form of the outline of a clinical development programme.

The new phase III study that would be required by the company to carry out would involve two studies on obesity, each for the duration of one year. A study, longer than 2 years in duration, would also have to be carried out in order to assess the safety profile of the drug in terms of cardiovascular events.

The drug has in the past been shown to cause significant weight loss and boasts a safety profile that the company is confident will be borne out in wider trials. The big pharmaceutical companies are not ready to give up on their weight loss treatments despite previous failures before the FDA especially at a time when there are so few options available to those suffering from obesity. The question is, who will partner up with the Danish company and when? The market is arid right now and desperate for a breakthrough.

Neurosearch, a Danish biopharmaceutical company that researches drugs, which act on the central nervous system, had been preparing to commence phase III trials of their obesity drug Tesofensine. Considering the difficulties faced by other drug companies recently in terms of regulation (notably Sibutramine, which works in a similar way) and the cost of phase III trials, Neurosearch will not continue to prepare for trials without a partner.

The safety profile of Tesofensine is relatively similar to other recent obesity drug candidates but the impressive weight loss results meant that the phase III trials were something to get excited about. Until Neurosearch receives the financial backing that they need, Tesofensine will be yet another promising obesity drug that has fallen before it even gets to the last hurdle.

Neurosearch, the experimental drug company, has announced that they are continuing with plans to launch Stage III trials into their new slimming pill, Tesofensine.

The drug acts in three different sites in the brain and increases the transmission of three neurotransmitters to the brain, dopamine, noroadreneline and seratonin. All the neurotransmitters act on appetite and metabolism.

Dopamine acts to send the brain messages about the pleasure derived from food, while noroadreneline and serotonin increase metabolism and reduce appetite.

The company has already published promising results from Stage II trials in the respected medical journal The Lancet, which showed that the results achieved by the drug were comparable to that of the successful slimming pill, Reductil. Reductil however was recently withdrawn from sale after concerns about safety.

The decision of the European Medicines Agency to withdraw Reductil has affected Neurosearch, with shares in the company falling by 5% when the decision was announced.

However the firm believes that its drug will meet FDA and EU safety requirements, with patients who took part in the trials experiencing few adverse side effects over extended periods of time. The most common side effects were dry mouth, insomania and stomach problems.

The Lancet study indicated however that members of the treatment groups could be more susceptible to changes in mood and agitation.

The company are carrying out ongoing analysis to combine safety data from two different trials, TIPO-1 and TIPO-4.

The Scandanavian drug company Neurosearch has announced that they will present their annual report on the 10^th of March. The company is expected to announce not only positive results from their trials into a treatment for Huntingdon’s disease, but progress in their trials for the obesity drug Tesofensine.

Tesofensine is likely to considerably boost the company's profile, as well as its market worth, as trials continue. Already data from early stage trials showed that patients taking the highest doses of the drugs lost up to 12.8kg over the course of treatment, twice what people taking Reductil lost in clinical trials.

Researchers first became aware of the drug when they were running trials into its effects on patients with Parkinson’s and Alzheimer’s disease.  They noticed that patients experienced unexpected weight loss and so trials were launched into its potential as a weight loss drug.

The medication works by changing how three chemicals, noroadreneline, dopamine and serotonin, send messages to the brain. They reduce appetite and improve sensations of being full, which make patients more likely to eat less.

It is believed that of three doses of the medication which have been trialled, the middle dose has the best results, achieving optimum results while causing the least amount of side effects. Reported side effects have included dry mouth, nausea and blood pressure increases at the highest dose.

If the medication continues to be successful in trials, then there will be a considerable market for it. Obesity is a growing worldwide problem, with 1 in 3 Britons expected to be overweight by 2012. Recently Reductil, also an appetite influencing medication, was withdrawn from sale, meaning that there is a considerable unfilled demand for a product that would support obese patients' efforts to eat less.

However the drug is not expected to complete clinical trials and be approved for a few years, though investors will be keen to hear Neurosearch’s update on progress.

The recent decision of the European Medicines Agency to withdraw the slimming pill Reductil from sale has left a lot of patients feeling bereft. Currently, the only slimming pill available with prescription in the UK is Xenical and while a lot of patients have had a lot of success with this drug, for others it just doesn’t meet their needs.

Reductil is a medication that assists with feelings of satiety after eating, meeting the key need of many patients who often blame their weight problems on their inability to control how much they eat.

We at The Online Clinic are therefore waiting with interest to hear reports on Danish firm Neurosearch’s trials into Tesofensine, which like Reductil is an appetite influencing drug.

Previous results showed that the medication could lead to results not only comparable to those achieved by patients taking Reductil, but better by a significant margin.

Patients also seemed to tolerate the medication well, though some did report side effects such as dry mouth and problems related to constipation. There were, however no reports of patients experiencing depression while taking the medication, a serious concern as Acomplia (another ill fated weight loss drug) was withdrawn after patients reported suicidal ideation.

Tesofensine is about to go into Stage III trials, the final stage of human testing before the FDA and European Medicines Agency makes a decision about whether approval will be granted or not. We will of course be writing about any breaking news on this new drug as it comes.