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Drug manufacturer did not present evaluable study data on the appropriate comparator therapy

Fampridine (trade name Fampyra®) has been approved in Germany since July 2011 for adult patients suffering from a higher grade walking disability (grades 4 to 7 on the EDSS disability status scale), as a result of multiple sclerosis (MS). The German Institute for Quality and Efficiency in Health Care (IQWiG) has assessed the added benefit of the drug pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG). According to the findings, there is no proof of added benefit, as the manufacturer's dossier contains no evaluable study data for the comparison between fampridine and the appropriate comparator therapy.

G-BA specifies physiotherapy as the appropriate comparator therapy

MS is a chronic incurable inflammatory disease, in which the patient's own immune system damages nerve tracts in the brain and spinal cord. In some patients, some muscles are in permanent spasm or are paralysed. If the disease is more advanced, patients may develop a walking disability.

The Federal Joint Committee (G-BA) has specified physiotherapy as the appropriate comparator therapy for the benefit assessment. This treatment must fulfil the requirements of the German Guideline on Remedies (Heilmittelrichtlinie). In addition, the patients must receive optimised standard therapy for MS.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1310

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So, the OH tried this drug in the last few weeks and has actually deteriorated. I have not seen such a rapid and more scary deterioration in him before. He is off the drug now but I fear the bad legs are here to stay.

I have been taking Fampyra for about 3 months. I started Gilenya 8 weeks ago. I feel great at the moment, have a lot more energy to do stuff. Is this as a result of Fampyra or Gilenya or a combination of both? I have monitored my activities closely over the past few months and now I am going to stop taking Fampyra at the weekend. Fampyra took effect very fast when I started so I expect the reverse to happen when I stop. I will continue to monitor my energy levels etc. and see if there is any difference. I was never really interested in an increase in walking speed just in walking ability.
Prior to starting Fampyra I had been on Tysabri for almost 5 years with no adverse effects while on it and no rebound when I came off it.

I have tried both Fampyra and compounded 4-AP. I do not notice a speed increase in walking, I do note that my control of movements and balance are improved while on 4-AP (ie Fampyra).

Just a brief update on my position. I am now a week without taking Fampyra. I certainly feel that my walking is not as good as it was last week but my general energy levels are great. I am not too concerned about my walking speed once I can get around the house etc and do the stuff I want to do. I will post again later.