A promising new drug has completed Stage 2 trials in the UK, specifically targeted on Trigeminal Neuralgia pain. Quoting from the article,
"Convergence Pharmaceuticals said the drug – a sodium channel blocker known as CNV101480 – significantly reduced the severity of pain and the number of sudden attacks (paroxysms) in TGN patients. Pain severity decreased by 55% and the number of paroxysms decreased by an average of 60% when compared to a placebo."
This is great news! Thanks Red. Currently I’ve got through the majority if not all of the medications for TN. So a new medication with hope of it controlling or turning off the pain would be super. In sure their many others whom are looking forward to even the possibility of a new medication. Thank you for the info once again.
So does this mean anything to US patients? Does the FDA accept overseas trials? Or is this an already existing drug that could possibly be used off-label? Sorry, this all might be answered in the link, but I just had surgery Wed. (nothing to do with TN-but the TN seems to be on vacation for now) so I'm no t able to do much or concentrate much.
Your question is complicated, Maureen. FDA acceptance of overseas trials isn't automatic, but there are myriad ways to work with or around that principle. My outright guess at this stage is that Convergence Pharmaceuticals may partner with a US firm to bring the drug to market here as nearly as possible at the same time as in the UK. Off-label use is also conceivable, particularly if Convergence seeks early approval of the drug as a Migraine treatment.
I will submit correspondence to the company to ask if they can share their plans and schedule estimate for bringing the drug to market in the US. Watch this space -- it may take a while to get answers, and they won't be under any obligation to provide them.
Cant find any info detailing drug use on both TN type 1 or 2, seems type 1 is more related to female suffers and type 2 is female and male. Hope the drug works on type 2 and is made available on the UK NHS.
I have sent Convergence Pharmaceuticals an email to hopefully have a question answered, I may have to speak with my GP to get an early insight as to the drugs use on type 1 and type 2 TN.
Thanks Red. I haven't been around much, 2 shoulder surgeries 3 wks apart and still recovering. Excited to see what this means in the big picture. I so appreciate you keeping up on all of this. blessings~~
I also wonder what is meant by open group. I know I am coming across as a bit of a buzz kill here, but I often hear of great results in small studies that do not hold up when the medication is tested in larger test cohorts. As it is, I went to the medical companies website, and they do not think they will be getting the medication into clinical trials here in the states until some time next year,
saraiderin said:
67 people is not a large study group. I will be interested to see how the medication works in a larger test study.
Sara, 67 people may seem like a small cohort, but we have to remember how they were selected: the incidence rate for TN is about 12 to 22 new cases per hundred thousand per year. So that 67 probably represents over 50,000 people in the general population.
The new med has also completed Clinical trials for use in Migraine, which is promising. That said, like you, I look forward to hearing results of large-scale clinical trials.
Red here is a response I got from Kevin Gunn, Convergence Pharmaceuticals
Dear Mr XXXXXXX,
Thank you for your note which was forwarded to me.
I am sorry to hear of your wife’s condition. As you probably know there are a number of treatment options available to sufferers of TN and I can only suggest that you consult with your medical specialist about these options if she is not adequately responding to carbamazepine.
Concerning CNV1014802 it is currently only at the earliest stage of human testing and it will require a number of years of further human clinical trials under strictly controlled conditions before it can be determined if it is a safe and effective medicine suitable for widespread commercial use. Unfortunately it is not possible to say how long it will take before it is available in Japan, even if it meets the regulatory criteria for approval.
Hi Red, wonder if you have any info on this new drug being available in Australia??? I can only hope
Richard A. “Red” Lawhern said:
Your question is complicated, Maureen. FDA acceptance of overseas trials isn’t automatic, but there are myriad ways to work with or around that principle. My outright guess at this stage is that Convergence Pharmaceuticals may partner with a US firm to bring the drug to market here as nearly as possible at the same time as in the UK. Off-label use is also conceivable, particularly if Convergence seeks early approval of the drug as a Migraine treatment.
I will submit correspondence to the company to ask if they can share their plans and schedule estimate for bringing the drug to market in the US. Watch this space – it may take a while to get answers, and they won’t be under any obligation to provide them.
Anne, it will be several years before the drug is available even in the UK, and perhaps longer in other areas of the world. Please note the posting above from George Tokyo...
Sorry to rain on your parade,Hon. This process is unconscionably slow. But it is that way because of disasters like Thalidomide. So the drug testing and trials system is very conservative and safety-oriented.
What are the chances that when it comes to the United States, the FDA might allow it to be used under the Compassionate Use clause. Oh, I know you can not answer that, just thinking out loud. You make a excellent point as to why the approval process is slow, but at times it is maddening!
Richard A. "Red" Lawhern said:
Anne, it will be several years before the drug is available even in the UK, and perhaps longer in other areas of the world. Please note the posting above from George Tokyo...
Sorry to rain on your parade,Hon. This process is unconscionably slow. But it is that way because of disasters like Thalidomide. So the drug testing and trials system is very conservative and safety-oriented.