I feel a little negligent. I heard back in December that Merck KGaA's oral drug, cladribine, had not been approved by the FDA for use in multiple sclerosis. I mentally shrugged and didn't do any further research into the situation (mainly because there was so much excitement about the CCSVI and MS thing).
I had wrongly assumed (again, naughty me) that there was a failure to show significant improvement in some MS endpoint and that was the issue with the FDA application. Not so. As it turns out, the application for cladribine tablets for use in multiple sclerosis was incomplete - a clerical error, rather than a substative one, it seems (although details are very difficult to come by).
Perhaps the application was put together in a hasty fashion in a bid to beat the other main oral MS contender, fingolimod (also known as FTY720), to market. Analysts say that Merck was going for a second quarter of 2010 release of cladribine tablets for MS in the US.
Indeed, as of January 20th of this year, Novartis had filed the application for fingolimod with the FDA. Even better was the news that Novartis decided that the lower 0.5 milligram dose was the winner in terms of lower side effects with still-significant benefits over the 1.25 mg dosage.
Bottom line on these drugs (from studies published in the New England Journal of Medicine):
- Both drugs are immunosuppressants.
- In both drugs, higher doses were slightly more effective, but also came with more side effects.
- In 96-week study, 80 percent of people taking cladribine stayed relapse-free, compared to 61% of the placebo group. Read the original article from NEJM here: Oral Cladribine or Placebo for Relapsing Multiple Sclerosis.
- In a 2-year study, between 70 and 75% of people taking fingolimod stayed relapse-free, compared to 46% of the placebo group. Read the original article from NEJM here: A Placebo-Controlled Trial of Oral Fingolimod in Relapsing Multiple Sclerosis.
- In a different one-year study, between 80 and 83% of people taking fingolimod stayed relapse-free, compared to 70% of the people taking Avonex. Read the original NEJM article here: Oral Fingolimod or Intramuscular Interferon for Relapsing Multiple Sclerosis.
My bottom line? Let's see what happens. These orals that were all the buzz about a year ago seem to have been mentally pushed aside by people in the frenzy over CCSVI. Also, many neurologists have said that they are not willing to quickly put people on these drugs right away unless there is a good reason (besides the universal dislike of injections). Needless to say, there are a lot of players on the MS stage at the moment for us to watch.
Have an opinion? Share it in the comment section below.
So far I’ve not read of any advantages that I’d be willing to drop taking my injections for in favor of a pill.
However, I wonder how detrimental a risky drug might be if offered to a newly diagnosed patient as an alternative to taking injections.
On the one hand people have opted to not get on an injection therapy because, well, they don’t want to self-inject.
On the other hand people who would otherwise gotten on injection therapy, now might opt for an untested pill.
It will be interesting to see what happens, since I guess these are the choices we all have to make, and more choices is better than less – so long as we’re being well informed by the drug companies, which is never something you can take for granted.
Equally important was the Jan 22 FDA approval Elan’s (marketed in the US by Acorda) controlled release formulation of fampridine. Ampyra (Fampridine-SR) was shown in clinical trials to improve walking speed for MS patients (note, Ampyra is approved for ALL forms of MS!). Ampyra is administered in pill form (10 mg twice a day). It can be taken with current therapies (CRABS) and commonly prescribed symptom support drugs such as Baclofen. It is not recommended for those who have a history of seizures or impaired renal function (neither of which apply to me).
For me this is even bigger than the cladribine approval. I tolerate the interferon (Rebif) well, don’t mind the injections, and feel comfortable with the risk benefit ratio. I can wait for a new immunomodulator.
However, my increasingly worsening gait issues that do limit activity, is the hardest and most distressing feature of my MS. I cannot wait much longer on this issue.
Ampyra will be available for prescription in March 2010. I am preparing a packet for my neurologist (I’ve already emailed him to alert him that we will be talking about this at my next scheduled appt).
This approval represents the best news that I have seen in a long time.
Is there any news on when Ampoyra will be available in Europe? I understand that it will be manufactured in Ireland? My Neurologist is encourageing me to get it but I cannot access it as my Neuro does not have a license to practice in the US. Does anyone know a Neuro in the US who will prescribe for a patient in Europe until it becomes available here?
“between 80 and 83% of people taking fingolimod stayed relapse-free, compared to 70% of the people taking Avonex.”
I would like to know the numbers on all of the MS drugs.
I am taking copaxone.
I was so excited to hear about an oral M.S. drug, I am sick of injections, but after reading that the drug has not been throughly tested and the rush by the money hungry drug cos. to get fda approval I think I like my injectagles. I been stable, no relapse, for 2 years, and they are tried and tested by many M.S. pts, no wierd side effects and no has died using them!!!!!!!!!!!!!!
My son has MS, and I have had MS type symptoms for approx. 30 years and do not have a confirmed diagnosis. My neurologist said that this is all that unusual for MS. That being said, I am not a fan of medications at all. In fact, I have read that the MS meds only are about 30% effective. And they all have significant side effects. And I believe that they have only been around since approx. 1993. My son is currently on Rebif, and I have many concerns about his future health based on all of the things mentioned above. And now everyone seems to be apologizing for forgetting the drug companies’ work on oral medications. Why are we all so happy to support the drug companies? I wish the pharmaceutical industry would put some of their money that they use to find poisons (for lack of a better word) to put in our body and do some studies on diet and lifestyle and the effect that has on MS. But there’s not any money there. Little wonder that there are only testimonials on how these integrative options work. Sorry to burst anyone’s bubble who thinks that meds are the only answer. I’m hoping that this CCSVI study proves beneficial. Pam
Serrapeptase which is a supplement has been used in MS and it clears blocked arteries like CCSVI does, I think that there needs to be more large scale studies of CCSVI to give us suffering from MS more hope.
jennifer, i read your comment about serrapeptase , do you know if there were any studies done on the effects of serrapeptase on ms? I tried to look for it and did not find any. thanks
I have tried and failed most of the approved dmds (avonex, copax.,tysabri, & rebif)…I am now in the fty720 study…am on the drug and doing great. It has been the only drug I have taken that I can say I feel better while taking. I am glad to have the opportunity to participate in another tool we can choose to fight this battle.
vgarn
I just don’t like herpes and skin cancer as potential side effects. I think I’ll stick with my Betaseron for now.
Does anyone know how often the new drug is taken? How many milligrams, etc.
Greetings Tammy,
0.5mg x daily i have heard is the recommended dose. I too have been waiting to get the new oral ms drug. My neurologist says mabe. mid summer for the UK I am not taking anything currrently. Stopped taking C0paxone since end of November and have to wait for the Copoxone to leave my body before the possibility of starting Tysabri – WHICH I REALLY DO NOT WANT IN MY BODY for the reasons of the obvious side effects – which could be quite final. I am however taking ldn (low dose naltrexone). Cant say it really really stops the weakness in my legs but i feel ok with taking it.
Heard of a new natural breakthrough since my last research episode. Called Changa -An antioxidant Super Oxide from the Maple Tree – has healing properties.
Do check it out on Google.
Peace and Joy,
Yeshi.
Great to hear Merck asnd Novartis are going to put fingolimod and cladpradine available in pill form sometime in 2010…Two questions..1).How much are these ant-MS drugs going to cost? and 2) Will these drugs be available / have any arresting effects of MS for those of us diagnosed with Primary progressive MS?.
If not, have any MS research been initiated to find ways /drugs that might slowdown even arrest the debilitation caused by patients with PPMS (Primary Progressive MS), the more rare and seemingly most mysterious form of MS. We PPMS patients deserve some $research dollars to be allotted to our concerns now too! We do not have the luxury of waiting 10 years for new MS remedies!
Have a good friend and neighbour with ms. He just started weekly injections when we heard about ccsvi. I was just wondering, in the short term, wouldn’t a drug like cialis help if it relaxes the inner lining of veins if this idea about blood flow obstruction turns out to be true?
Just starting to think about simple and safe things to do while the research continues on.
Treasa,
FYI
Alas, I responded to your question, however, sorry to say, it never appeared!
(I suspect it’s because I included a link to a competitor’s site and/or might have made an unflattering comparison – a joke really – about the differences in the greed-quotient between European and American pharmaceutical companies.)
To all of you who prefer a free-flow of ideas and are under the impression that you’re getting the benefit of all available input – minus censorship – on the MS section of About..com, think again.
Congratulations, Julie. Do the pharmaceutical companies really own About.com, too? If not, it must do wonders for your self-esteem to imagine you’re protecting the “stupid” folk with MS from thinking for themselves?
(Julie: Maybe your “brain fog” is more than MS? Perhaps About.com’s management should be more involved in evaluating your decisions?)
Good luck to everyone who comes here to share the ideas that help us all cope with the day-to-day challenges of living with MS! I’ve read some of you on other blogs, and hope to run into you there!
Pen M. Hutchinson
Julie,
I would be interested in an article on stem cell treatment. Have you considered including this in your newsletter?
Pen,
I understand that you are upset that your comment about the European vs. American greed quotient never appeared. I never saw it and certainly never deleted it (nor did anyone at About.com, as I am the sole moderator of any comments to my blog).
I am sorry that you assumed that either I (or some editor at About.com) was engaging in censorship. If you read the other comments on this and other blogs of mine, you will certainly see that this is not the case, as it takes something very egregious for me to consider editing or deleting a comment.
It surprises me that someone who is also living with MS (as I assume you are) would casually refer to cognitive dysfunction (”brain fog”) in defense of your suggestion that I am not giving people the whole picture. I can assure you that I am living with very real symptoms of MS, including cognitive dysfunction, which I try to be very open about (despite this symptom being a source of stress and sadness for me), just as I try to cover all approaches to MS treatment – even the ones that aren’t the “headliners” in the US.
Again, I am unsure what happened to your original comment. I wish you luck in your quest for the truth, however.
Folks,
I am not sure if this is the right topic, but have you heard about CCSVI which might give the the best MS treatment ever!
About ampyra. It was released about a month ago. My question which I have submitted to the manufacturer involves the potential for changes in seizure threshold in combination to anitdepressants like wellbutrin. If both drugs have the potential to cause seizures and although both are prescribed at doses below the seizure threshold what happens if they are mixed? Dr Julie have you found anythong on this? The ampyra which is 4Aminopyridine has the potential to change things by altering the way electricity is hooked up in the central system via potassium channels. well butrin functions on the juncture between the nerves associated with chemicals that work on this same threshold and potential for the electricity to be crossed from one point to the next.
People like me with MS who are on medications like wellbutrin for nerve damage where it is proposed that the nerve regeneration hook up may not be intact have the potential for additional complications. from meds like these. hence my question.
does anyone else in this community have any information on this?
I was diagnosed with RRMS about two months ago. The only treatment offered to me was daily injections which I declined. I was aked if I wanted to participate in a blind trial using an oral drug called Teriflunomide. Reading through everyones comments I don’t see this drug mentioned. Does anyone have any information about it?
I have had this rediculous disease since 1986. I will GLADLY give the syringes to some one else. I’ve been a pin cushion for way too long. I have tried, Avonex, Betaseron, Copaxone and Rebif. I really want a permanent break from needles.
I was diagnosed in 1985 and was 13 yrs old. I had 2 initial flare ups and then my M.S. went dormant till 1997 when I went on Avonex. I have changed once since to Betaseron and am counting the days to change because I look like I need a skin graf because I unfortunately am a rare one that doesn’t do well on the Betaseron. My skin doesn’t take well to it. It is time for a change and it won’t be another needle.
Why is there no talk about LDN.(low Dose Naltrexone)
Is it that the drug companies can’t make money on a compound made at your pharmacist?
This stuff works great.
I have been on Copaxone for 14 months, (daily injections) and my neurologist suggested Ampyra. After convincing the insurance company that there is no generic alternative, I begin taking this oral medication on June30th. I bicycle regularly and within one week had doubled my normal routine ( 10 miles to 20 miles ). By the second week, I had tripled the mileage. I am maintaining my workouts with the biking and also weightlifting and feel so much more energetic . For me, the Copaxone/Ampyra combination appears to be working and allowing me to continue doing something that is healthy and I that I love. I have Primary Progressive MS and was diagnosed in Dec. 2005.
Rob- there are other options besides a daily injection. I have not heard of that medication, but maybe you should see a new neuro to get more options for meds.
Ever heard of Chaga Mushroom? It is a Super Oxide grown on the Maple tree or Birch tree and has healing properties. An immune system modulator to heal and tonify.
If you Google the name you will be linked to many other sites which offer information of its use. and how to get it in your possession for use to consolidate your treatment protocol.
Yeshi.