The FDA's PNS and CNS Advisory Panel is in the process of taking hearings on Acorda's (ACOR) Fampridine-SR.
It seems that part of the risk of overdosing on Fampridine-SR is that patients feel good on it and may take too much on purpose. I get around this with the compounded version of 4-Aminopyridine by only giving it to patients I know wouldn't take additional doses, even if they felt better.
This patient attitude testing will be part of the REMS (Risk Evaluation and Mitigation Strategy), as will a specific specialty pharmacy; does this mean that primary care physicians will not be able to prescribe this drug?
How about regular neurologists?
Medical Director
Neurologique
info@neurologique.org
www.neurologique.org
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