possible to get topical pirenzepine for PN prior to FDA approval?

No they normally pay the patient so much to participate. How do you know if you are given the medication or a placebo because you have to have both groups.

This early access in NOT part of any clinical trial. If you are accepted into early access that means you get the medicine you pay for BEFORE all clinical trials are completed.

I’m a little bit dumbfounded reading that you’ll charge $1900 for a 6 month supply of a drug that is unproven! I’ve never heard of the company nor the drug previously. Considering that peripheral nerves recreate at a rate of 1 inch a month in healthy individuals, those with diabetes have a much more difficult road to repair due to the diabetic nature of tissue damage, how long the damage has been present and older aged patient are all barriers to successful treatment.
https://www.mayoclinichealthsystem.org/hometown-health/speaking-of-health/treating-repairing-nervous-system#:~:text=The%20chance%20of%20nerve%20regeneration,nerves%20regenerate%20and%20restore%20function.

$1900 for six months of an experimental drug approved by the FDA for compassionate use is anything but exorbitant. Ask those who pay sometimes pay more than $5000 out of pocket per month for experimental drugs related to cancers, autoimmune diseases, etc., The FDA authorizes pharmaceutical companies to pay the direct cost of manufacturing, shipping, monitoring and reporting on patients who request compassionate use of a drug approved by the FDA for that purpose. Just because we do not yet have a fully approved drug that can regenerate nerve does not mean that one will never be developed, and if we do not encourage research aimed at developing such drugs we will have to content ourselves with the woefully inadequate drugs that we now have for this condition, drugs that primarily address only pain and come with very significant negative side effects. There are several pre-clinical studies indicating that meaningful nerve regeneration may be achievable, and in fact, there are some clinical data in support of this, as well. Qutenza, for example, though approved by the FDA for its pain alleviating qualities in PN, has convincingly demonstrated an ability to regenerate some nerve fiber in the diabetic foot, and phase 1 and phase 2 clinical trials of WinSantor’s pirenzepine drug has demonstrated even more evidence in support of this goal, leading to the FDA’s willingness to grant it compassionate use clearance pre-full approval. There is no lack of candidates for the phase 3 trial. That is entirely separate from the compassionate use program, which requires a minimum number of applicants before the FDA will let it proceed. As for the phase 3 trail itself, that is going to be enormously expensive, particularly since this will be the first PN drug indicated for nerve regeneration, if it is approved; prior drugs, which addressed only the pain issue, were relatively easy to get through the FDA process by comparison. My understanding is that WinSanTor is still trying to obtain sufficient funding to ensure that the phase 3 trial can go to completion. By the way, I have no financial or any other connection with WinSanTor.

Thank you for the feedback. But in terms closer to home as an example. If I was a diabetic with PN and im now 72 and literature I’ve read on nerve regeneration states 1 inch a month providing the drug works and the patients DM or associated illnesses don’t further hinder successful treatment. Mouse models appear to show some success but until phase III clinical trials are performed it’s a crap shoot. The other diseases you mentioned are much more severe than PN and in my opinion are in a different ball park of severity.

I've looked at virtually all of the studies; there is no definitive high quality data in support of an absolute "1 inch per month" regeneration limit.

I have just talked to Winsantors CEO, Stanley Kim. He states that he has 10,000. people signed up for the compassionate use of WST-057, but he needs funding for the submission to the FDA.
If all 10,000 people would each give $10.00 on his GoFundMe page, he could submit to the FDA and start the compassionate use program.

Thanks, that is very helpful. I will definitely contribute. It is really appalling that there hasn't been more research directed toward disease modifying drugs/therapies for neuropathy. Unfortunately, almost all of the funding in recent decades has gone into palliative (pain-reducing) drugs for the condition. I'm all for reducing pain but am not satisfied to leave it at that. Hence it behooves all of us with these insidious disorders to support serious disease modifying research.

Here's from a recent WinSanTor communication indicating compassionate use could commence as early as January, 2025:

Under the Fast Track designation WST-057 has been granted by the FDA, WinSanTor can provide the product to patients within the Expanded Access program, which most people know as compassionate use.

Expanded Access is granted to patients who have no solution for life-threatening conditions, or suffer from seriously debilitating conditions. If all goes well, the process of getting WST-057 into patients’ hands could begin as early as January 2025.

PFS patients in the US who suffer from PN can then discuss compassionate use of WST-057 with a licensed physician. If the physician agrees that the drug might benefit the patient, the physician will file paperwork with the FDA, who in turn will allow WinSanTor to fill the prescription.

WinSanTor CEO Stan Kim notes that his company has limited resources for drug approval, so Expanded Access patients will need to pay the direct costs of the drug, which is estimated at $300 per bottle, and lasts about a month. The initial release will be earmarked for patients who participated in the diabetic peripheral neuropathy study, but WinSanTor will look to expand to other indications shortly thereafter.

“The best thing interested patients can do now is complete our anonymous SSD survey as soon as possible, while encouraging fellow patients to do that same,” says Kim. “The more patients who participate, the more likely it is we can raise additional funding to continue exploring WST-057’s efficacy within the PFS and PSSD patient populations.”

Finally, he adds, patients should subscribe to the WinSanTor newsletter and watch for updates on WST-057’s availability via Expanded Access.

This is all true. But after registering everyone should donate at https://www.gofundme.com/f/donate-to-bring-relief-to-peripheral-neuropathy-patients
They need to collect $200,000 before they can start the compassionate use program