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 Reductil however was recently withdrawn from sale after concerns about safety.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.