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FTY720 (Fingolimod) Oral Medication for Multiple Sclerosis–Results of TRANSFORM Trial

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Competition can be a good thing, especially for the consumer. Recently, I reported that Merck submitted a request to the European Medicines Agency requesting approval for the use of oral Cladribine for the treatment of Multiple Sclerosis.

Since all the major treatment options for MS are currently injection or infusion based, a safe, effective oral medication for MS would be a breakthrough. Merck is not the only pharmaceutical company in the race to be first-to-market with an oral treatment for Multiple Sclerosis. Novartis AG is giving Merck a run for their money. They are actively pursuing approval for their own version of an oral MS medication, FTY720 (Fingolimod). Formal requests for approval are expected to be submitted later this year in both the US and Europe.

FTY720 is an “immune-modulating” drug. It works by binding to the receptor site on immune cells and then trapping them in the lymph nodes. Since the immune cells are trapped in the lymph nodes, the theory is that they are unable to go scampering about in our brains and cause the damage which results in MS symptoms. Phase III (code named TRANSFORMS) of the FTY720 trials has been completed and Novartis presented the results earlier this year at the American Academy of Neurology convention in mid-April, 2009. The results were promising with 80-83% of all patients on FTY720 relapse free! No matter how you look at it, those are quite impressive results.
During the course of the trial, participants were given one pill, administered once a day. The dosage consisted of either 0.5 mg or 1.25 mg. It was reported that the 0.5 mg worked better than 1.25 mg. During the course of the trial, Novartis specifically compared FTY720’s performance to Avonex. Avonex is currently in the number one spot in the MS medication marketplace. Novartis reported that the 1-year relapse rate was reduced by 52% in low-dose patients and 38% in high dose patients compared to Avonex. The long-term trial results were also excellent reporting as follows:
• 67% remained relapse free after three years
• 89% free of inflammatory disease activity (confirmed via MRI scans)

Add a Comment7 Comments


Please check back with us from time to time and let us know how the trials are going and (more importantly) how you are doing. It will be so exciting to get actual first hand feedback from someone involved with the study.

Here's wishing you good luck and sending positive thoughts for a good trial result for you.

December 21, 2009 - 10:17pm
EmpowHER Guest

i wish the best of luck to everyone. i am on the new trials of pills that will be 2 and 1/2 years and looking forward to participating. i was a researcher when able to work so it will be nice to help as a subject now. especially luck to the man who is experiencing all the side effects and getting worse.

December 11, 2009 - 5:45pm

I wish your husband the best of luck in these trials. I know that we are on the verge of an alternative to the injection based treatments that are currently available. I'm hopeful that one of these new pills currently being tested will be a home run in terms of safety and effectiveness. Ultimately, I'm still praying for the cure. Best wishes to your husband.

November 16, 2009 - 10:58am
EmpowHER Guest

My husband has PPMS and is on the clinical trial, het started january 14th 2009.
Till now there is no improvement but he is getting worse.
But it is a 50% placebo trial, so we don't know if he is on the real drugs.
But he does has all kind of (possible)side effects.
We hope for the best, this trail for the PPMS patients takes 3 years.
If you want to share your experience: postbusvanwest@yahoo.com

November 8, 2009 - 9:35am
EmpowHER Guest

I like to think that the high price I am paying for my current medication helps keep research moving on future MS drugs as there is a large potential market. In almost all cases, where there is a profit motive, there is investment.

August 24, 2009 - 6:28am

Outstanding news! This article shows the best of the pharmaceutical industry. Sometimes there is a real breakthrough.

August 11, 2009 - 7:30am
Blogger (reply to Linda Fugate PhD)

Yes! This is an exciting time in the research for MS and the preliminaries look good. A third company is also working on an oral medication as well but they are not as far down the pipeline as Merck and Novartis. I'm hoping that one of the drugs turns out to be as effective and as safe as the current therapies. If we get a "yes" on both of those issues, we'll have a real winner. I'll be watching the progress!!!

August 11, 2009 - 8:37am
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We value and respect our HERWriters' experiences, but everyone is different. Many of our writers are speaking from personal experience, and what's worked for them may not work for you. Their articles are not a substitute for medical advice, although we hope you can gain knowledge from their insight.

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