NeuroSearch’s Tesofensine Advances to Phase III Testing

weightYesterday, OneMedPlace reported on several companies that are developing anti-obesity drugs. Another name can be added to the list: NeuroSearch of Denmark is preparing to advance their experimental weight loss drug, tesofensine, to the final stage of clinical testing. On Monday, the company announced that it had completed a successful End of Phase II meeting with the U.S. Food and Drug Administration.  An earlier Phase II study showed that tesofensine led to an average weight loss of 10 percent over 24 weeks. The study concluded that tesofensine produced a weight loss twice that of currently approved obesity drugs. Tesofensine is a monoamine reuptake inhibitor, a drug that increases the neurotransmission of dopamine, noradrenaline and serotonin simultaneously. Each of these neurotransmitters influences appetite and metabolism. 

NeuroSearch’s Phase III plan, which was endorsed by the FDA, will consist of four placebo-controlled studies involving approximately 5,700 patients with and without co-morbidities such as type 2 diabetes and hypertension.

Tesofensine also shows minimal to no potential for substance abuse, according to data presented last month at the 17th European Congress on Obesity. Some dopamine-increasing appetite suppressants may be subject to substance abuse due to their stimulant properties.

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