Hi there,
I just came across this article about the cream H-100 (https://pubmed.ncbi.nlm.nih.gov/26700214/), and it seems that the cream is quite effective at improving Peyronie symptoms. Do you know why it was taken off the market? Is there any places where I could still buy it?
"H-100 showed significant improvement in all Peyronies Disease parameters at 6 months: mean stretched penile length increase (22.6%, P=0.0002), mean curvature reduction (40.8%, P=0.0014), and mean pain level reduction (85.7%, P=0.004). Placebo group showed no significant improvement except for mean stretched penile length increase (6.8%, P=0.009)"
Thanks!
Very interested in this aswell
Latest article I can find, they are trying to get FDA approval still. Following 505(b)(2) pathway to cut that time down
https://www.globenewswire.com/news-release/2022/05/03/2434708/0/en/Petros-Pharmaceuticals-to-Pursue-505-B-2-Pathway-for-H-100-Company-s-Novel-Topical-Investigational-Treatment-for-Peyronie-s-Disease-Which-Impacts-More-Than-1-in-10-Men-in-the-US.html
Thanks for the article, that's some great news! Is there any chance to know how much time getting such an authorisation takes?
I also sent the article to my doctor (the one that I shared), he told me he will email the editor to clarify several things because the trials of this cream were rather limited.
Very interesting. A topical gel that could cure peyronies, almost seems too good to be true!
I used H100 for about 6 months in 2021. I was (and still am) throwing the kitchen sink at this so while I have had some improvement in a few areas, I attribute those to other parts of my regimen. H100 is pricey, and I went in with little faith in it, but I couldn't leave any stone unturned. My own doctor, who I got to write me the script, said it would not penetrate and that they actually tested this on folks getting excision and grafting. They applied H100 prior to the surgery and then they tested the excised tissue and there was none of the actual product. Dr. Trost mirrored this to me as well.
Dorian
Dorian thank you for the great information
Quote from: Dorian on June 09, 2022, 10:33:48 AM
I used H100 for about 6 months in 2021. I was (and still am) throwing the kitchen sink at this so while I have had some improvement in a few areas, I attribute those to other parts of my regimen. H100 is pricey, and I went in with little faith in it, but I couldn't leave any stone unturned. My own doctor, who I got to write me the script, said it would not penetrate and that they actually tested this on folks getting excision and grafting. They applied H100 prior to the surgery and then they tested the excised tissue and there was none of the actual product. Dr. Trost mirrored this to me as well.
Dorian
Hi there Dorian,
Many thanks for the info, it's really useful.
Do you know if this cream is still available on the market in the US? If so, how much does it cost and how much do you use monthly?
Thanks
I just looked up my receipt and the last (2nd) purchase of 3 months worth was in August 2021. It was $870 for 3 month supply from the compounding pharmacy. It's an odd container that you rotate part of it for "3 clicks" which then pushes out the metered dose you apply. So, 1 tube/bottle lasts a month.
I'm judging from what I'm reading here, they had to pull it off the commercial market while they go through the motions with the FDA.
Dorian
I second what Dorian said, a previous discussion on this made clear that you cannot access it as it is currently being trialed by the FDA.
In addition, I would like to share once again what Uroweb says about H-100. The panel consists of experts in Peyronies Disease who review the clinical findings regarding numerous treatments:
"There is no sufficient and unequivocal evidence that topical treatments (verapamil, H-100 Gel [a compound with nicardipine, superoxide dismutase and emu oil] or steroids) applied to the penile shaft, with or without the use of iontophoresis (now known as transdermal electromotive drug administration), result in adequate levels of the active compound within the tunica albuginea. Therefore, the Panel does not support the use of topical treatments for Peyronies Disease applied to the penile shaft."
The article you reference focus on the use of the cream in the acute phase specifically, where it seems that practitioners are more divided in their opinions. The sample in this particular study is also very small (22 people) so it is difficult to draw any robust conclusions from it.
Regarding the claim about transdermals, there is this result,
10 out of 14 tested positive. https://pubmed.ncbi.nlm.nih.gov/12686831/
H100 is using nicardipine, a calcium channel blocker as verapamil is, and can also be used with iontophoresis
Yes sure, it is a similar product but it is also not the same. There is little evidence that topical treatments, such as H-100 or topical Verapamil, actually lead to significant improvement. They have been tried because they are non-invasive - 'wouldn't it be nice if we could just apply a miracle cream and everything would get better' type of thing.
The article you linked to is about whether electromotive drug administration helps to get the substance into the tunica. Again, this study used a small sample and only tells us that 10/14 individuals had more traces of Verapamil in their tissue after electromotive assistance. It does not mean that their condition improved following transdermal therapy. See the conclusion below:
Conclusions: Electromotive drug administration is a safe and noninvasive treatment modality. Verapamil was detected in 71.5% of tunica albuginea specimens after electromotive drug administration with a wide range of verapamil levels. To our knowledge whether these levels affect change in Peyronie's disease plaque, resulting in improvement in penile deformity, is unknown and requires further placebo controlled trials.[/b]