Oral DMD

[daisy.girl]

Has anyone seen or heard about this new oral drug for MS?

http://www.mstrust.org.uk/news/article.jsp?id=3635

[Quixotic1]

Sho makes a good point that the oral meds are far stronger against the immune system than the current DMDs.  They truly slam the immune system down and the two big concerns are fatal or severe infections and future cancers.  Anytime you remove the cancer surveillance ability of the immune system you can increase the chance of one developing - especially lymphomas.

My neuro felt that I was a good candidate for one of the upcoming orals.  He doesn't like Copaxone (for me) and my depresssion was out of control on the interferon.  However, that kind of immunesuppression is very concerning for me.  Also, I can't afford the current DMDs - make too little to afford it and too much to qualify for assistance.

I'm sure Dr. C and I will be discussing it next month.  Meanwhile I'm squirreling away my pennies to pay through next year's Medicare donut hole.

Quix

[Lulu54]

I have heard more than one neuro say that for their patients on the injectables, if they are doing well on those shots they will not consider moving them to the orals.  If it ain't broke, don't fix it seems to be the attitude by many.
Lu

[shoshin]

I was in a clinical trial for FTY720 (formerly known as Fingolimod; now with the new and improved name of Gilenia). I was on the real drug and so far as I can tell it had no particular effect on anything. However, some people have had very good results and it is even thought that FTY720 might have some neuroprotective properties and might contribute to healing.

Gilenia was fast-tracked by the FDA in February and may be approved in the U.S. as soon as this fall. Cladribine is also in the race to be approved as Sharon pointed out. They had a bit of a setback with the FDA. I forgot the details, but I don't think it will mean a long delay.

There does seem to be some controversy in the neurology community over the new oral drugs and some neuros have expressed reluctance to prescribe them.

The pills are certainly more convenient. They are considered more effective. They will probably be at least as expensive as the current DMDs so that's probably a wash.

However, they are all real immunosuppressants (rather than immunomodulators like the current CRAB drugs) and are therefore more dangerous. The CRAB drugs may have unpleasant side effects but they don't kill people. Two, maybe three, people died of infections in the FTY720 trials. I think they may have been on higher doses than the one that the FDA is being asked to approve, but when a larger group of people start to take the drug, other problems may emerge. There have been a few cases of skin cancer, which were all treatable, and some other problems that are reversible if you stop the drug. PML was listed as a possible side effect on the consent form that I had to sign for the trial. So far as I know, no one taking FTY720 has gotten PML, but they don't know all the factors that go into that and I don't think the problems with Tysabri emerged until after the drug was approved.

Lots of food for thought and no easy decisions.

sho

[coco31]

I may be totally wrong but I believe oral DMD's in the form of fingolimod and cladribine are in there final phases of trials and are awaiting FDA approval. We may even see fingliomod before the year is out. I think this is amazing! injectables are tough work no matter how long your on them or how often you take them. There is something incredibly appealing about not having a sharps bin in my house, needles in my fridge, and an autoject or 2 hanging around. To me personally these are constant reminders that I have MS. And I dont have a problem anymore with having MS (I did at the start) but I have a serious problem with the unpredicable nature of the disease. . . .

On plus note. We haven't really been offered anything new since copaxone and that was quite a while ago. It will be interesting to see how other treatments pan out.

According to "UPTODATE" a data base neurologists use the following drugs are also being tested:

1) Alemtuzumab
2) Azathioprine
3) Cyclophosphamide
4) Daxlizumab

Hopefully we'll see more developments and association with CCSVI before we need to look at toxic types of therapy.....

[HVAC]

My MS Specialist says the oral DMDs are ten years on the horizon because of ironing out the bugs. Of course Copaxone was in oral form before injection and failed miserably. One of the problems with the oral DMDs is going through the gastrointestinal system from what I have read.

The other issue according to my doctor is the oral medications will be more expensive than the injectables. The insurance companies will want people to be on the less expensive proven drug.

Alex

[essdipity]

I believe this is fingolimod, which has been in extensive clinical trials in the US. Not approved yet, though.

My neuro is very wary of all the oral meds being tested, and made it plain that none of his patients doing well on the current DMDs will be switching. He feels the oral ones present too many dangers.

From what I've read, that is a harsh assessment, so at my next visit I will inquire further.

ess