New oral drug looks promising for FDA approval

[Cherie]

I thought you would like to read the attached article:
Another oral drug for relapsing multiple sclerosis , teriflunomide looks to be on a smooth path to approval, thanks to positive data from a key phase III trial, researchers said.

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[SalpalSally]

Thanks Cherie. Looks like more of the 30% same to me. Good for some but not for most.

IMHO, Scientists should be testing patients more for the type of MS they have and then come up with meds that treat, successfully, their particular MS.

And, I'm not talking RR, SP, RP or PP. It may be more what triggered our MS than what disability nitch they put us in.

[Cherie]

Almost the same stats as Avonex. Not as good as Copaxone, Betaseron or Rebif. Both Tysabri and Gilenya have better stats but it's another alternative. The nice thing about this is that 21 different countries partook in the trial. AND thid is the fifth Phase III trial on this drug so they are fine tuning the dose and results.

[agate]

Thanks for posting this. An oral drug has obvious advantages over an injectable. Those studying these drugs are very concerned about "patient compliance," I notice. Too many of us fall by the wayside and go off our DMD, and all too often it seems to be because people balk at injections. Or they put up with them for a while but then rebel.

[renee]

It is nice seeing a med not being fast tracked.

I am a 'not entirely compliant' patient.
Mr. Med wants to help me.
I whip out all the paraphenalia, look at site reactions and cringe.

Pressing down the injector will probably land in muscle and
playing cowboy to a herd of doctors who are way out of sync
has me reeling.

Compliance will happen but- OH- I feel my low grade MRSA fever
coming on... 2 months now. What a partay!
Columbus weekend stay in the hospital for the secondary complications?

Something like my Rebif in pill form without the side effect of
lowering blood pressure.
That would be nice.

That costs no more than Tylenol.
YES.

[Virginia]

Thanks Cherie, this drug may help a lot of people. I guess we need to try to be optimistic about these new drugs. I just want them to keep coming until one happens to come along that does us all just worlds of good.

Renee, you are a dreamer - "That costs no more than Tylenol"!!!

[Cherie]

Renee,
You sound discouraged. I can relate. I hope and pray the fever resolves and your health returns quickly. I finally was taken off Rebif after 6 years on because the fevers and opportunistic infections could not be kept under control. A few doses of IVIg helped give my body a chance to fight what was happening then the drug was switched. I hope you find an answer.

The drug touted as "rebif in pill form" (Cladribine) has been dumped as too costly to bring to market. The FDA asked for a third phase III trial and the manufacturers said it would put them too deep into debt to do that and wait for income to start flowing once the drug was approved. Side effect profile on that drug was far more tolerable than that of Gilenya and it appeared , from early stats, like it was more effective at reducing relapses and staving off disability than anything currently on the market.

The fact that this drug is in it's fifth phase III trial means that there is likely to be a large price associated with it to cover research and development expenditures.

[renee]

Thanks for your sympathy, Cherie.
I am usually pretty darn patient but this is new to me.

I'm not sure my PCP understands what he is dealing with-
the gravity of a lingering infection in a immune compromised person.
He is quiet and businesslike but he may also be rigid.
Oh-oh. I'm a wildcard and...this may not be a good match.

In trying to keep all my docs in the know I have been leaving message updates.
Voila! I suspect I offended my PCP and
inspired a territorial contest. Chuckle.

Oh well. I offended an imaging tech when she had never seen what she was supposed
to ultrasound. WHOA!
I suggested she find previous images from three weeks before- she did.

I'm glad I was raised by a doctor dad who promoted asking questions of any authority.
One of your alma mater.
He was a midwestern guy big on listening and delivering thoughtful, appropriate and honest answers.

I hope I emerge with additional wisdom from this new experience.
Growth and a love of life is what I am shooting for in this incarnation.

Peeps, take care of yourselves.
Find something to laugh at.

You never know what is on the horizon.

[Cherie]

((((Renee)))) Keep asking those questions and challenging complacency.

[Virginia]

Renee, you sound like you are feeling quite bad. An infection that lingers is not what anyone, even a person without MS, can handle for too long. I hope they get this straightened out very soon. I guess with a Father who was a Doctor you are well versed in being your own advocate, assuming you do not have anyone else available. I hope you are not feeling too bad to do just that when you need to.

Not all Doctors are like your father. There are some that are sensitive to the point of overlooking the good of their patient, if they feel they have in some way been slighted or been questioned.

Cherie, I am sorry to hear that Rebif will not be coming out in oral form. I am still on it. It would be nice to not have site reactions.

[Cherie]

I was really banking on Cladribine being approved but it was not. I have to take the approach that there is a reason for that. Site reactions , which were not bad for the first 4 years, got progressively worse during the final 2 years. Even now, three years after my last dose, when I run a fever, some of those abdominal sites will redden and itch. Weird?