As we approach the magic date of January 22nd 2010, the MS community waits in anticipation whether the first oral drug with MS in its label, will be approved by the FDA.
No, I am not discussing EMDSerono's Cladribine, Novartis' Fingolimod, Teva Neuroscience's Laquinimod, Sano-Aventis' Teriflunomide or Biogen-Idec's BG00012; the first drug with MS in its label will be Acorda's (ACOR) Fampridine-SR.
So, what can we do to help transition smoothly to this new compound?
1. I have already discussed the need for patients to show up on the FDA PDUFA date
2. Neurologists who can make it, should show up too. I am seriously considering making the trip.
What else can we do once the drug (what will it be called in the end? It didn't get approved in the Fall and we know that it will not be called Amaya anymore [see my prior blog on naming])?
As I have discussed in the past, there are clear advantages to the approval of Fampridine-SR over Compounded 4-Aminopyridine (hopefully the FDA will not demand lower dose trials prior to approving Fampridine-SR). I would like to demonstrate this to everyone by compiling patient experience with Compounded 4-Aminopyridine.
So, please email: neurologique@gmail.com and tell us:
1. The side-effect you had on the compounded medication (especially, seizure, confusion, headache and stomach problems).
2. What dose you were on when you had the side-effect.
3. How long you had been on the compounded medication.
4. Whether you had recently received a new bottle when the side effect happened.
4. Which compounding pharmacy you used.
Your answers will help us convince everyone that we should be switching to Fampridine-SR once it is approved.
Remember, safety comes first.
Medical Director
Neurologique
info@neurologique.org
www.neurologique.org
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