Ara290
 

Hi there,

I understand there has been a few clinical trials on the above drug which i believe has been successful in Sarcoidosis and Diabetes. Does anybody think this will be used for a more broader range of neuropathy in the future?

Loulou

Here is an article about it:
http://www.prnewswire.com/news-relea...280635872.html

If it retains its designation for sarcoidosis associated PN...others would not be likely to afford it as insurances would require a diagnosis for sarcoid.

This happens here with Lidoderm (lidocaine) patches which only have FDA approval for post herpetic neuralgia.

As a peptide it looks like it will be injectable. It might get clearance in about 3-5 yrs. It may however open doors for PN treatments also in the future.

Thanks for posting this.

Thank you Mrs D, i am hoping it will open doors for other neuropathy sufferers, i believe it also states it is disease modyfying , unless i have got this wrong, i am all new to this.

3-5 years? ugh... I want it now (as I'm sure everybody else does). when are clinical trials? With clinical trials must you have one of the diseases specified? IF you are idiopathic are you out of luck?

sorry, one more question. I see this drug is for diabetic or sarcoidoisis neuropathy. does that mean it won't work on other types of neuropathy? Wouldn't trials want to be done on many different types of neuropathy? Why only those two? Sorry, I don't understand much about this stuff

This drug is being tried in the US. Does anybody know how drugs come to Canada? In general, if drugs are approved in the US are they approved in Canada around the same time? Or does it take years for to see it in Canada?

some people do very well on Lyrica and that's for diabetic neuropathy....we all respond very differently to the medications out there....so sadly it's a hit or miss kinda of thing....:o

For the clinical trials there is a very exact inclusion/exclusion criteria. It depends on what indications they are looking to have on the final label. Phase 3 trials test the drug on individuals that have the disease that they are looking to treat.

Drugs can't be made so narrowly as to treat diseases in a precise way. There won't know this until there is more data. It depends on the mechanism of the drug as well.

It would be used off label if positive results were seen with other neuropathies.

It could be used off label, but unfortunately it sometimes takes so long for that to happen. Usually there has to be an extensive amount data on the drug and typically will be an older, generic medication. But anything is possible.

I work at a very large contract research company and we are doing things now to make clinical trials faster and more efficient the future. There is just so much time, money, and waste that has to go into the process. It's very frustrating.

Website
 

I use clinicaltrials.gov to check out what studies are ongoing for any given drug.

https://clinicaltrials.gov/ct2/resul...&Search=Search

I hope this drug can be used sooner rather than later

I mean used of label sooner rather than later

If the cost of this new drug is really high... off label will be too expensive for most people.

Lidoderms were only just over 300 dollars off label, and many could not afford them.

It all depends on the FDA approval process in that regard.

oh dear, well there is always hope I guess, i'm in UK so not sure how that would work with NHS.

LouLou,

NICE determine availability based on criteria like cost, cure effectiveness, pain resolution, improved quality of life…

Dave.

Thank you Dave, I wasn't sure how it all worked. :)