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possible to get topical pirenzepine for PN prior to FDA approval?
Neuropathy | Last Active: Oct 29 6:57am | Replies (32)Comment receiving replies
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.
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$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.