42 million is nothing in the drug world. One reason it is so expensive is that the expectation of sales is low. The smaller the pool of potential patients the higher the price. While patches are costly to make, they are not that costly, and there is no expensive drug in it.
The cost is to cover the smaller user base and the control of dispensing etc.

I used to sell these products, so I know how many left the shelves each week. And each week is a huge exaggeration...they actually sat around until they expired for the most part and we'd have to send them back. When people got the cream on RX they never came back for refills.

Since this thread is so complex with alot of information on it, I'm going to request it be moved to the subforum above, where the informational posts are.

So look for it there in the near future.

Zostrix was put out there specifically for neuropathy caused by Shingles. Even tho it is OTC we used to keep it behind the counter at first, and use it only on RX --because it was only detailed to doctors. But it soon was moved to the BenGay section when advertisments started appearing in magazines for the general public. It was pretty expensive at first.. back then over $25 a tube. Now it is less. This link to Amazon for Zostrix HP ($15) has a very negative but typical review/response:
http://www.amazon.com/Zostrix-Potenc.../dp/B000F5IEK8

I had a tube by another company, here, my son used for hand pain from his overusing his video gaming controller... he liked it and it didn't burn for him. But he didn't use it for very long either. I just couldn't stand it. It was the weaker strength.
In all the years (over 10+) I have been on this board and its predecessor only a handful have ever reported success with it.
That is just the way it is.

There have over the years been other drugs in various pipelines to block Substance P. Merck had one it was going to sell as an antidepressant. But studies didn't pan out for it. It then went RX for nausea from chemo. Emend.
I recall some others now in the pipeline for pain, and only time will tell if they withstand the 3 tiers of clinical trials. It would be nice to have something really effective, so I am ever hopeful. But it might be a long time in coming.

Typically the press releases you can find on the net are very glowing.
They imply great success always, so that perhaps people will invest.

This location is actually the nitty gritty of the Pharm industry, and this is the link to Astellas:
http://www.cafepharma.com/boards/forumdisplay.php?f=68
So far there is only one brief mention of the "pain patch" coming out in Europe in Dec '10. But when Qutenza comes out, the reps will have alot to say about it. (from their perspective). Cafepharma is usually unpleasant IMO, but sometimes interesting data can be had from it.

With all due respect, Mrs. D, one negative review out of a single review is hardly informative...

Here are some 30 odd reviews, evenly divided between those who hate it because they can't see further than "it burns like hell!", have not used the product according to the instructions, are allergic or only suffer mild pain in the first place... AND those who think Capsaicin is nothing short of a miracle...

http://www0.epinions.com/reviews/Capzasin_HP

Also, let's remember that 'Capzaicin HP' is the highest potency available for OTC Capsaicin at 0.1% and that users are well advised to begin with a much lower concentration, such as 0.025%...

Since Qutenza will likely be a low volume product, as you remarked, the $42 million distribution rights paid by Astellas is all the more interesting...

Even more interesting is that there was little to chose in a recent failed clinical test pitting Qutenza for HIV Neuropathy and a .4% Capsaicin patch used as a placebo, both providing around 30% pain improvement over one hour...

http://www.pslgroup.com/dg/24704e.htm

A 30% improvement is nothing to be sneezed at and may well make some type of pain bearable: not having found the 0.04% patch yet, I have ordered the 0.025% Salonpas patches, which I intend to test later on with the view of reporting the results here...

The patch used as placebo was most likely made for the study.
I don't expect it to be available, yet. Often studies are done this way and the patches have to be exactly the same in appearance in order for the study to be properly blinded.

Here is the study abstract:
http://www.ncbi.nlm.nih.gov/pubmed/19821411
So this is what we are discussing. It doesn't work for all. And remains unpredictable.

Let us all know how you do in any case. Remember, this does not change the cause of your pain. It is palliative only. If your pain is being generated in your back and not the feet, then placing patches on the feet may not work consistently. You may have to use them on your back in that case.

Good luck.

Since there are a number of clinical studies on Capsaicin, we can always quote that, which we like the most, or which better supports our respective arguments...

NGX-4010 [Qutenza], a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomized, double-blind, controlled study with an open-label extension.

OBJECTIVES: To assess the efficacy, tolerability, and safety of NGX-4010, a high-concentration capsaicin dermal patch (capsaicin 640 microg/cm(2), 8%) in patients with postherpetic neuralgia (PHN).

METHODS: Patients were randomized to receive NGX-4010 or control patch in a 4-week, double-blind study. This was followed by an open-label extension phase (up to 48 weeks total) where patients could receive up to three additional treatments no sooner than 12 weeks after initial treatment. The primary efficacy variable was mean change from baseline in mean morning and evening numerical pain rating scale (NPRS) scores.

RESULTS: During days 8-28 after the double-blind treatment, NGX-4010 patients had a mean change in NPRS scores from baseline of -32.7% compared with -4.4% for control patients (P = 0.003). Mean NPRS scores decreased from baseline during week 1 in both treatment groups, remained relatively stable through week 12 in NXG-4010 patients, but returned to near baseline during weeks 2-4 in controls. Mean change in NPRS scores from baseline during weeks 2-12 was -33.8% for NGX-4010 and +4.9% for control recipients. A similar decrease in NPRS scores from baseline was maintained with subsequent NGX-4010 treatments, regardless of the number of treatments received. Transient increases in application site pain were adequately managed with analgesics. No increases in application site reactions or adverse events were observed with repeated treatments. No patients discontinued the study due to an adverse event.

CONCLUSION: NGX-4010 is a promising topical treatment for PHN patients, which appears to be tolerable, generally safe, and effective.

http://www.ncbi.nlm.nih.gov/pubmed/20113411

I guess if the FDA based its decision on your study, Qutenza would NOT have been approved...

Also, note that there was no longer any competition with the low dose Capsaicin patch that had done so well in previous tests...

so keep using the capsaicin and see how it works out long term for you if it is helping you now. let us know how it goes.

--most of us have learned to look critically at studies/papers that come out trumpeting "magnificent" results, especially those published int he US, as opposed to those that come from Canada, Europe, or Japan, places in which the influence of big pharma on what gets published and what doesn't isn't as pervasive.

Still, many of us would like to have new drugs that show promise for the relief of neuropathic (and other) pain. Substances based on capsaicin are certainly worth investigating, and it is likely they will have positive effects for at least some people, though these may be variable based on dose, formulation, and particular genetic background. In that sense, they'll be very much like other drugs used for neuropathic pain--anti-epileptics, anitdepressants, and even opiates and synthetic equivalents (such as Tramadol) work well for some and not others.

In all probability, individual differences in genetic make-up, substance metabolism, and pain mechanism explain the highly variable results associated with these trials, though many of these are still too complex to disentangle. The problem comes when studies that show equivocal results on symptoms, or other effects not intended, are either suppressed or relegated to less widely disseminated media channels.

Qutenza was passed by the FDA under the Orphan Drug Act:

http://www.checkorphan.org/grid/news...etic-neuralgia

What this means:
http://en.wikipedia.org/wiki/Orphan_drug

I think this partially explains the high price of these patches.