oral medications
Howdy All,
thought I would kick start a forum on the new oral medications in the pipeline, when I came across these 2 articles. The first one talks about a report in The New England Journal of Medicine which talks about fingolimod and cladribine, and how they are more effective then the current DMD's, but with side effects obviously, then mentions fampridine for walking as well.
http://www.npr.org/templates/story/story.php?storyId=122774705
this second article just talks about Cladribine and its success rates in the trials.
http://www.straitstimes.com/BreakingNews/TechandScience/Story/STIStory_4...
Cheers Kristy
Disclaimer
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Please Note: Any advice given on OzMS must not be taken as medical advice, it's merely advice given by members from their own experiences of living with Multiple Sclerosis. Always check with your GP or Neurologist or other medical professionals, it's the smart thing to do and only logical! If you have something to contribute please do so, everybody has something to offer.
Comments
oral meds
Hi Kristy,
Thanks for posting! I have the feeling that we will be hearing a lot more about these two in the year to come!
Helen.
yeah I agree with you helen,
yeah I agree with you helen, there seems to be something popping up nearly every week about them!! As long as it all stays good news, I will be happy
Life is like a box of chocolates.... never know what your going to get
I've got them
Hi ladies and gents,
I have the copies of these medical articles if you want them. There are some major perks to being a librarian
Just post me and I will see if I can send them to you.
Cheers,
Jodi.
"Don’t judge each day by the harvest you reap, but by the seeds you plant" Robert Louis Stevenson.
Hi Jodi, Your a champ I
Hi Jodi,
Your a champ
I would love a copy if you dont mind?
Cheers Kristy
Life is like a box of chocolates.... never know what your going to get
Just an update, came across
Just an update, came across this article today, which talks again about the trials for these orals.
However, this one mentions severe adverse side effects. Namely Herpetic infections, causing 2 deaths
They were caused by fingolimod.
http://www.medscape.com/viewarticle/715566?sssdmh=dm1.582717&src=nldne&u...
Hope they can over come these sort of issues somehow!!
Kristy
Life is like a box of chocolates.... never know what your going to get
Cool!
Has anyone had any contact with anyone in Australia who has taken part in the trials for cladribine? My interest comes via the newsroom so if anyone has any extra info they can pass onto me I'd really appreciate it!
I found this article stating that the American FDA refused to file the drug for use with MS. This happened in Dec 09... http://online.wsj.com/article/SB1000142405274870330050457456832223014796...
Anyway - any info gratefully accepted!
Thanks!
"Peel the apple in your hand, not the one on the tree."
Author: Robert Jordan Wheel Of Time Book 8 Path of Daggers
Warning! Unsupervised children will be given a shot of expresso and a free kitten.
Oral meds
Hi Kristy,
I can see the same approach happening here as it was for Tysabri, if a person cannot tolerate current DMD's or is having many relapses they will probably be first in line for the new orals.
I remain to be convinced about a drug which is an immune suppressant, because it virtue of its nature there will be many issues with it. The other thing is that would have to be weighed is my current drug and how it is performing, when you haven;t had a relapse in over two years and no new symptoms since 2005, I would really have to think long and hard about taking the risk.
My neuro has said to me in the past not to be the first one to take up new stuff until it has had time to be tested.
Helen.
Oral Drugs
Release 20th Jan 2010
Novartis for fingolimod and Merck Serono for cladribine
http://www.businessweek.com/lifestyle/content/healthday/635184.html?camp...
Other drugs in the pipeline
Teva's laquinimod sanofi-aventis' teriflunomide and Biogen Idec's BG-12 in Phase III development
I think you'll fiind the deaths occurred at the high dose
Hi Kristy,
Couldn't open your attachment but believe the deaths occurred with the use of the higher dose of Fingolimod in the trials. The higher dose was also causing some heart issues too.
But what they found was the lower dose of Fingolimod showed the same success rate as the higher dose without the nasty side effects, so this is the one they are going with.
This herpetic infection has occurred with both Fingolimod and Cladribine.
Here's an extract from The New England Journal of Medicine which discusses that:
Adverse effects were similar in all three trials of cladribine and fingolimod, and rates of events leading to discontinuation of a study drug were low but still at least twice as frequent with high-dose cladribine (7.9% for the 5.25-mg dose) and fingolimod (10% and 14% for the 1.25-mg dose).
Herpetic infections occurred among patients receiving both cladribine and fingolimod. The rate of herpes infections among patients receiving the 1.25-mg dose of fingolimod was 5.5%; such infections were serious in three of these patients, two of whom died. Twenty cases of cutaneous herpes zoster were recorded among patients receiving cladribine, three of which were serious.
Here's the link to the full article.
http://content.nejm.org/cgi/content/full/NEJMe0912019?query=TOC
Full Text of Journal Articles on Cladribine and Fingolimod
Hi All,
Full articles are now availabe AT CHARGE, THE FREE PERIOD SEEMS TO HAVE EXPIRED
A Placebo-Controlled Trial of Oral Fingolimod in Relapsing Multiple Sclerosis
L. Kappos and Others
http://content.nejm.org/cgi/content/full/NEJMoa0909494?query=TOC
Oral Fingolimod or Intramuscular Interferon for Relapsing Multiple Sclerosis
J.A. Cohen and Others
http://content.nejm.org/cgi/content/full/NEJMoa0907839?query=
A Placebo-Controlled Trial of Oral Cladribine for Relapsing Multiple Sclerosis
G. Giovannoni and Others
http://content.nejm.org/cgi/content/full/NEJMoa0902533?query=T
Helen.
Hi Guys, Karen, yes you are
Hi Guys,
Karen, yes you are right, the deaths did occur at the higher doses, and thanks Helen for posting the links to the full articles
I will have a good look at them when I get a chance.
I agree Helen, I wont be rushing out to change to one of the orals, (unless of course something changes dramatically with my health or current treatment). I am becoming more wary of them the more I hear about them..... I know for some, they are going to be a welcome relief to injecting... but for me, I dont know whether the benefits will out weigh the risks..... maybe if the reduction to the relapse rates is fantastic (i.e, a lot better than the 50ish% they claim now), or like I said my health deteriorated, or my meds werent working, then I may give them a go, but at the moment, I am a happy injector....
And my Neuro has the same opinion as yours Helen, he said he would wait for them to be available here in Aust for a couple of years before changing anyone who is doing ok.
Cheers
Kristy
Life is like a box of chocolates.... never know what your going to get
I'm away from home at the
I'm away from home at the moment, but just saw this on a friend's computer and wanted to share. I can't do the research into it just now, but will when I get home tonight, or tomorrow. In the meantime....
Fampridine (extended release pill version of 4-aminopyridine) was approved yesterday for use in the USA. This is the first oral medication approved so far for the treatment of Multiple Sclerosis. With the USA about to start prescribing this medication, it hopefully won't be too much longer before Australia follows suit.
HAWTHORNE, N.Y., Jan 22, 2010 (BUSINESS WIRE) -- Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for AMPYRA(TM) (dalfampridine), an oral treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA demonstrated efficacy in people with all four major types of MS (relapsing remitting, secondary progressive, progressive relapsing and primary progressive). AMPYRA can be used alone or with existing MS therapies, including immunomodulator drugs.
http://phoenix.corporate-ir.net/phoenix.zhtml?c=194451&p=irol-newsArticl...
From what I've read so far, Fampridine does not prevent nerve damage caused by MS, but in about a third of the trial patients, the damage done to their nerves repaired to such an extent that their walking improved significantly. I gather then that this is probably a medication for symptom control, rather than a medication for all..... but it's a start!
I'll read more about it when I get home.
.
.
*EDIT:
Rather than continue discussion about this medication here where it's mixed up with other drugs, I refer you to a whole new thread titled
" Ampyra - received FDA Approval (improves walking)" which Helen started. It just makes sense to keep all the discussions in the one place.
Thanks for that Anne, its
Thanks for that Anne, its good that it can be used in all 4 types of MS too!!
Life is like a box of chocolates.... never know what your going to get
They are doing oral drug
They are doing oral drug trials at John Hunter Hospital. I'm not too sure what oral meds they are trailing, but I do know that 1 in 4 people are on a placebo.
In order to go on to the trial, you must not have been on any other meds for three months, prior to having the tests done to see if you qualify for this study.
If you want some more information on this, I can get it any my next visit on Feb 3rd
Nobody will ever win the battle of the sexes.
There's too much fraternizing with the enemy.
I found my invite to
I found my invite to participate in the oral drug trials at John Hunter Hospital.
They are trailing TERIFLUNOMIDE. they are trailing two doses: 7mg & 14mg. the chances of being assigned to one of the teriflunomide doses is 2 out of 3, and the chance of being assigned to placebo is 1 out of 3.
If any one wants further information, just let me know
Deanna
Nobody will ever win the battle of the sexes.
There's too much fraternizing with the enemy.
Howdy All I came across this
Howdy All
I came across this info today on 5 of the future oral meds. It is a summary (from april 2009) on effectiveness, safety etc.
A few things stood out as worrying, such as:
Cladribine, there is suspected/unknown risk for women who want to have children in the future, due to possible teratogenicity.
Fingolimod, apart from the herpes related deaths, comes with the risk of skin cancers, but also 3 cases of Melanoma were reported.
Apart from that, the article isnt a bad one, as it compares trial data (up to that date), so you can have a look at how they stack up against each other. Obviously, the ones that are doing the best, have the higher rate of safety issues
But anyway, here is a link to the article if anyone wants to read it.
http://neuropipeline.com/?tag=teriflunomide
Life is like a box of chocolates.... never know what your going to get
Clinical trial oral med
Oral trial underway
http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1679
Howdy all Came across this
Howdy all
Came across this today, it seems fingolimod, which I assume by the article has been re-named - Gilenia, has been granted priority review status, which means that the FDA review period will be reduced from 10 months to 6 months, on the following grounds:
"The FDA grants priority reviews for investigational medicines that could offer significant advances beyond current treatments or where no adequate therapy exists."
Heres the link:
http://www.pr-inside.com/novartis-oral-multiple-sclerosis-development-co...
Cheers Kristy
Life is like a box of chocolates.... never know what your going to get
howdy all I came across an
howdy all
I came across an article today on BG-12, Biogen are enrolling the first patients in a combination phase II trial called EXPLORE, where the oral med BG-12 is being used with the interferons or glatiramers, for use in those who are still experiencing disease activity on injectables. This drug has undergone phase III trials, and I think they may still be ongoing, which is testing the oral therapy on it own, those trials are called DEFINE and CONFIRM.
here is the link
http://finchannel.com/news_flash/Pharmacy/65239_Biogen_Idec_Announces_En...
Sorry if this has already been posted somewhere, I have been out of the loop for a while... I did a search but couldnt find it already on the site, so fingers crossed I am not doubling up here
Cheers Kristy
Life is like a box of chocolates.... never know what your going to get