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.