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Old 05-22-2009, 06:54 PM #1
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Arrow New AED/stabilizer up for FDA approval - eslicarbazepine (Stedesa)

Hi all,

just following up on research regarding eslicarbazepine - a drug (AED) i ran across years ago, and found it is coming to fruition.... about nowish!

Sepracor Announces Submission of Stedesa New Drug Application to FDA for Adjunctive Treatment of Epilepsy

it has already been approved in Europe (not sure if on market yet though.)

for more articles on eslicarbazepine (Stedesa):

More articles on eslicarbazepine (Stedesa) at drugs.com

This drug is supposed to be really good with refractory partial seizures, and supposed to help with depression too (!), but it is unclear if the implication is helping with being depressed from having uncontrollable seizures (that's depressing! ), OR - more pertinently to us - if it actually has antidepressant properties. What is unclear is whether non-epileptic depressed individuals were included in the trials. It is however implied that it shows potential both for epilepsy and affective disorders.

Another thing.
It is related to carbamazepine (Tegretol) and oxcarbazepine (Trileptal) so one might expect cross-sensitivity in individuals who have had issues with these two drugs. However, the structural difference of this drug does imply an improved safety profile, as well as different metabolic pathways than either carbamazepine or oxcarbazepine. Here's the abstract to a tech article on the drug, although from it i cannot deduce what the potential for any cross-sensitivity might be:

Eslicarbazepine Acetate (BIA 2-093)
Neurotherapeutics, Volume 4, Issue 1, Pages 88-96
L.ALMEIDA

Quote:
(EXCERPT from linked abstract)

It behaves as a voltage-gated sodium channel (VGSC) blocker and is currently under clinical development for the treatment of epilepsy and bipolar disorder. ESL shares with carbamazepine and oxcarbazepine the dibenzazepine nucleus bearing the 5-carboxamide substitute, but is structurally different at the 10,11-position. This molecular variation results in differences in metabolism, preventing the formation of toxic epoxide metabolites such as carbamazepine-10,11 epoxide. In pharmacokinetic studies in humans, ESL was rapidly and extensively metabolized to eslicarbazepine (S-licarbazepine), which is responsible for pharmacological activity. ESL has been tested in patients with refractory partial-onset seizures and was found to be efficacious and well tolerated.
If i come up with anything else i will post.

Or if anyone else finds anything more specific, esp. regarding the cross-sensitivity, please add to the thread!

~ waves ~ 1 large coffee + 600mg ibuprofen = doing mostly better

Last edited by waves; 05-23-2009 at 06:12 AM. Reason: removed repetious section
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Old 05-22-2009, 09:44 PM #2
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Default cross-posted to Medications Forum

i cross posted this to the Medications Forum (seemed appropriate). i am leaving the full text post in this thread all the same, since it's already here, however i think that the Meds Forum thread would be the ideal place to reply if you have added information regarding the med in general.

here is the thread in the meds forum:
New AED/stabilizer up for FDA approval - eslicarbazepine (Stedesa)

i think perhaps this thread could still be useful for us should we want to post comments regarding its impact or usefulness specifically for bipolar, at least, that is what makes sense to me.

i hope i have not confused anyone.

~ waves ~
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Old 05-23-2009, 01:30 AM #3
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HI,
I have no information to add so I can post here.
This is good news.
I imagine that it would have fewer side effects than Tegretol and Trileptal.

M.
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Old 05-23-2009, 06:03 AM #4
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Smile thanks for replying

Quote:
Originally Posted by Mari View Post
I have no information to add so I can post here.
Lol, Mari, you are a trip. well that made me smile.

just to be clear, i wasn't trying to fend off people from posting here... maybe it came off that way a bit. lol, now i wonder if my post in the E forum had the same effect.

i think here is good to post information or experiences with the med specifically for bipolar.

just if someone has more specs or general info on the med that would apply to all pathologies, it would seem to make sense to put that in the med forum thread (linked above).

Last edited by waves; 05-23-2009 at 06:05 AM. Reason: thanks for replying
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Old 05-23-2009, 12:37 PM #5
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I am wondering about this new medication, I was on trileptal and it stopped working for me aand I became hyponatremic, low sodium, anemic and increase in WBC from it and that is when we switched to lamictal.
So I will watch for further developements....
thanks
beth
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Old 09-14-2012, 01:12 AM #6
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Teeth on eslicarb. study presently. heres my news

I am a survivor of head injury, meningitis, coma and cavernous hemangioma: right parietal lobe. All "oh how fortunate you really are" aside, I do suffer from partial seizures. I have been on a variety of anti seizure meds. Most gave me no problems except ocassional extreme tired or perhaps times when we shouldn't operate machinery... things like that. Now I am on that study drug, eslicarbazepine. What effects that were abnormal for me were numb lips, no big difference in partial seizure occurance, though it did decline and two very specific incidences. They occured in less than two months apart from eachother. First, I had a sensation that was quite like the delerious physical sensation I felt first coming out of and recovering from coma. Second, I had not had a tonic clonic since just prior to 2006. I had then had a startling cluster of years there with sudden onset tonic clonic, indicitive of mri need which then discovered the cavernous hemangioma at the surface. Operated and removed, I had not had one since this month. This is alarming to me. Maybe I am a bad candidate for the medicine investigation. Yet, at the same time, I believe that someone with a great deal of brain damage, such as myself, also might be an excellent candidate for the investigation, that we might learn just how intricate the new med for the fda will behave. Chiming in with Android, BarbarG.
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Old 09-14-2012, 12:02 PM #7
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Welcome Barbara

And thank you for the information on how it has effected you. My son has had all kinds of seizures. He has what is the VNS, right now and is on 3 medications, Lamictal, Trileptal and dilantin. He was on Tegretol before the
trileptal it was his first medication. And he has been on most of the other medication, except phenobarb.

He is finally controlled, but we are right now reducing his trileptal, its the one drug that is causing the most in cognitive effects I believe. So it would be interesting to me to see how this new one does in the trials. And after if it
is approved in the states.

I have many friends who's children and many adult friends who need new medications.

Thanks Waves for posting this.

Donna
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