Treatment Prospects: Neramexane

[Markku]

Wikipedia's short article on Neramexane:

Neramexane is a drug related to memantine,[1] which acts as an NMDA antagonist[2] and has neuroprotective effects.[3] It is being developed for various possible applications, including treatment of tinnitus[4][5], Alzheimer's disease,[6] drug addiction[7] and as an analgesic.[8] Animal studies have also suggested antidepressant[9] and nootropic[10] actions, so there are a wide range of potential applications this drug may be used for. It also acts as a nicotinic acetylcholine receptor antagonist.[11]

Merz (the drug company behind Neramexane) tell the following:

Neramexane is a new substance from Merz research. Its efficacy in treating tinnitus is currently being examined in a large clinical study program. Initial findings appear promising. At present, Neramexane has not been approved in any country for the treatment of tinnitus.

It's being clinically tested, undergoing Phase III trials right now and they expect to have initial findings published in late this year (2011):

Neramexane has already been tested in a Phase II study including 431 patients with subjective tinnitus. The study demonstrated a reduction in the interference caused by the ringing in the ears. Due to the positive results, a study program with a larger number of patients was initiated to examine the efficacy and safety of Neramexane.

Neramexane is currently undergoing Phase III clinical trials for the treatment of subjective tinnitus. The Phase III program was agreed in detail with the responsible European and US American authorities (BfArM, EMEA, FDA) and will involve a total of roughly 1,200 patients in three international clinical studies. For 2 of the 3 clinical studies, inclusion of patients is almost complete.

The third study will take place in Europe, the USA and Latin America. The following countries will participate: Argentina, Brazil, Germany, Mexico, Austria and the USA.

Initial findings from this clinical development program are expected in late 2011. The next steps will depend on the results obtained.

Patients interested in participating in a study can download general information (in their own language) from the web portal ClinLife (with the exception of Latin America). See www.ClinLife.net for Europe, www.ClinLife.com for the USA, and other national portals under the corresponding country abbreviations (e.g. www.ClinLife.at for Austria).

Using these websites, patients can check their general suitability for a study in advance and can register themselves accordingly. They will then be contacted by a local program supervisor.

There have been a few users on different forums in the Neramexane trial, and all of the reports I've read have been borderline negative, meaning not noticing any kind of positive effect on tinnitus. But these anecdotal reports don't bear much weight: need to remember the possibility of them having the placebo instead of the real deal. Plus drug response varies from person to person, so few reports on websites need to be taken with a grain of salt.

And since earlier trials showed some positive outcomes and it's now at Phase III, I think it's possible this drug might help certain types of tinnitus at least to some degree.

Same thing as with the VNS, we'll have to wait and see.

Fingers crossed.


Merz' site for those interested: http://www.merz.com/research_and_development/neramexane-tinnitus/neramexane/

 

[Scarred]

My brother-in-law was in this trial but he got ___bad____ headaches and had to quit the trial. He was unbelievably disappointed.

 

[Markku]

Unfortunately Neramexane can be crossed off the list of treatment prospects.

More info here.

 

[lost horizons]

has anyone on TT tried Neramexane? If so, was it effective or not?

http://www.biomedcentral.com/1472-6815/11/1

 

[Nucleo]

It failed. Read Markku's link.