Monday, February 1, 2010

Coming Soon: Three New Oral MS Drugs

flickr pills - you should check how many you n...

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With all of the ballyhoo going on about CCSVI, I think I've been guilty of ignoring some of the more "mainstream" news regarding MS research and drug development. As enticing as the CCSVI theory is, it's still far from proven, and until CCSVI theory might turn into CCSVI fact, the arsenal in the fight against MS will continue to be made up entirely of drugs designed to either modulate or suppress the immune system.

Two such drugs, Cladribene and Fingolimod, are nearing FDA approval. Both of these compounds are immunosuppressants, but what sets them apart from other current MS therapies is that they are meant to be taken orally, not by injection or infusion as is every other MS therapy currently available.

MS patients currently on the injectable drugs almost universally hate having to give themselves shots on a regular basis. I'm sure there are a few masochistic types out there who relish jabbing themselves with needles, but aside from the demented, the news of oral MS therapies has been met with great enthusiasm.

Cladribene and Fingolimod were both proven in clinical studies to be very effective at cutting down relapse rates and enhancing lesions in RRMS patients taking the drugs. Fingolimod also appears to hold the promise of slowing down disease progression as well, a goal which has long been a holy grail of MS research. The drugs were shown to be comparable in effectiveness to Tysabri, which is currently considered the most effective MS drug on the market. As with most things in life, though, with the good comes the bad. Unfortunately, both drugs carry with them the possibility of some very perilous side effects, most notably the increased risk of dangerous infections, and in the case of Fingolimod, an increase in the incidence of skin cancer.

Both of these drugs significantly suppress the human immune system, thereby inhibiting MS patients' immune systems from attacking their own cells and destroying nerve insulating myelin, thus causing the nervous system damage seen in MS. While drugs of this type have been shown to have proven benefit to MS patients, the long-term implications of suppressing the finely balanced and hugely complicated human immune system remain to be seen.

I don't mean to scare people off of using drugs that have demonstrable benefits, but I really wish that MS researchers would start concentrating their efforts on finding the root cause of MS, rather than figuring out new and nifty ways of suppressing an immune system gone awry, which is actually a symptom of MS, not the genesis of the disease. I've said it before and I'll say it again: treating MS by suppressing the immune system can be crudely compared to treating a broken leg with painkillers. Symptom relief is definite and measurable, but the underlying cause of those symptoms is left entirely unaddressed.

A third MS drug also on its way to a pharmacy near you is called Ampyra, which sounds to me more like a drug that should be used to treat the undead than MS patients. Who names these drugs, anyway? Ampyra is the first drug on the market designed to increase the mobility of MS patients, which I think we all can agree is a very good thing to do. Ampyra works by increasing the conductivity of damaged nerves, and was shown in trials to help 35% of those taking it increase by 25% the time it took them to walk 25 feet. Not exactly scintillating numbers, but as the saying goes, any port in a storm.

Ampyra is a slightly modified time released version of an older drug known as 4-AP, which has been available from compounding pharmacies for many years. I tried 4-AP a few years ago, and found its effects to be subtle but noticeable. As my disability increased, I found it to be less effective, so I stopped taking it. When Ampyra hits the market, maybe I'll give it another try.

An interesting fact about 4-AP (and thus Ampyra) is that the compound is used as an industrial bird poison, and is very effective at killing off large numbers of our feathered friends when they become pests. It does this by frying their little feathered nervous systems. When used in small doses in nerve damaged humans, though, those same nerve exciting properties help damaged nerves to work better. Just to be on the safe side, though, when I was on 4-AP, I made it a point to stop trying to fly. It's very important to strictly follow dosing instructions with this drug, as higher doses can lead to seizures.

Back when I was getting 4-AP from a compounding pharmacy, a month’s supply cost something around 30 bucks. The compound wasn't patented, so it was relatively cheap. Who wants to bet me that Ampyra, which is almost identical to 4-AP but has been patented and marketed by the drug company Acorda, will cost a teeny-weeny bit more than 30 bucks a month?

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  1. I spoke to my neurologist recently about Ampyra/4-AP and she mentioned that dosing has to be very carefully regulated as you can end up cookoo in the emergency room not knowing who you are kind of crazy. Nice. And what I've read totally supports what you said, Ampyra is going to be waaaay more expensive than the get it at the compounding pharmacy variety. Nice again.

  2. And a more salient point, thank you for this blog. Your writing and photography are inspired. That sounds fruity, but it's accurate.

  3. I'm a fellow New Yorker now living on the West Coast with MS and love your blog. I just voted you "Best Patient Blog" on all my browsers! Good luck!

  4. Ampyra will cost slightly over $1,000 a month. Like the CRAB meds, Accorda Therapeutics, (biotechnology company that developed and holds the patent on it), will help patients with their co-pays and paying for the drug. Will Medicaid cover the cost? The website for the med is or try googling accorda therapeutics. You'll get lots of info. I agree, symptom management is a port in a storm. Time to find the etiology and maybe a cure. MS sucks, but I LOVE yur blog. Had I not been diagnosed, I wouldn't have found it. Thank you for making me laugh and think. Great photos, you have incredible talent.

  5. One thing to consider: for those of us on Tysabri the threat of skin cancer seems a lot less frightening than the threat of a deadly brain infection (PML). I will most likely be moving over to one of these pills when they come out. Same efficacy as Tysabri but no deadly brain infection? Sounds good to me!

  6. Hi Marc,
    my hubby Curt has ppms. dx in april 2009 so it's still pretty fresh. we notice big changes by the month with his right leg and his right hand acts up too. I'm just wondering do you have pain all day long?? And do you take anything for it without falling asleep? He takes 10mg baclofen so he can sleep at night and forget about hte constant pain, i guess spasticiy is the name for it. During the day he takes xenaflex 5mg always at lunch, it dulls it a tiny little bit but he still feels. he doesn't take any other medication because he is in the BG12 trial, if placebo or not, it hasn't done much. He has been on BG12 since July 2009.
    I wish we could find some for the pain without making him sleep. It hurts me as much as him seeing him in pain. I'm sure your wife feels the same. We have no children so i constantly want to take care of him. He tells me there will be time soon enough for that. He still can walk, but not much. He is Irish 25% and rest is all German- is that the reason he doesn't want to take any help, i mean a cane etc. I'm fullblooded German, we have been togehter 28 yrs incl the 4 yrs he was stationed in my hometown 'Hemau', Bavaria Region.
    Anyway, hope i don't bother your, just would like to know from someone else with the PPMS if anything can be taken for the pain.
    It's greatly appreciated, and keep up your stories. I read them all the time.

  7. Has anybody found the use of Ampyra to be beneficial?

  8. No.........I tried it for one month...Very expensive, side effects.........nausea, back pain, dry mouth..........
    I stopped after one month...
    Currently on Tysabri, since January 2008...
    Dx'd since 1994....hard, so hard.............the best of luck to everyone. Stay strong, we just have to..........

  9. I've been on Ampyra about four months and finding a bit of improvement in movement. I can step over small thresholds, while before I had to grab my pants to lift a leg. My physical therapy coach has also commented on my better movement on the exercise mat. Make no mistake, I'm not at a point where I can abandon the walker, but I'll take the modest improvement.

  10. i'm on ampere for about 1 yea.r lost med. about 6 mo ago didn't take it for about a month what a differences not having it. started back on ampere again will stay on but i lost my med again. so i need to try a way to get it. have to wait about 1 year for medicare .state med said making to much from ssdi thats what i get for working for 30 years