Neramexane is a new substance from the Merz research department. Its efficacy in treating tinnitus is being investigated in a clinical trial programme. Neramexane has not been approved for treating tinnitus in any country.
Neramexane has already been tested in a phase II trial in 431 patients with subjective tinnitus. This revealed a reduction in the impairment caused by this “ringing of the ears”.
Because of the positive results Merz initiated a trial programme with a total of three phase III trials where the efficacy and safety of Neramexane was tested in a larger number of patients with subjective tinnitus. In addition, a further open label study on long-term tolerability was completed in December 2011. This is thus the largest trial programme carried out up till now for the development of a treatment for subjective tinnitus.
In the phase III trials a total of 1265 patients participated. Of these 634 patients were treated with Neramexane in blinded trials and 819 patients in the open trial. The trials have been conducted in Europe, North and South America and South Africa.
The results for treating subjective tinnitus available till now in the development programme have shown very good tolerability. The necessary aspects required for approval have currently not been met. Together with its development partner, Kyorin Pharmaceuticals in Japan, Merz started another clinical study in October 2011, which is expected to be completed in 2013. When further data resulting from this study is available and an overall assessment of all the data has been made, the next steps will be introduced.
Stand: 20-Aug-2014, 10:44 AM
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