H100 - the new Topical Verapamil?

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nemo

Back on the forum due to a Peyronies Disease flare after a few years away. Trying to catch up on what's happened treatment-wise since I've been gone.  

Appears the Dr. Levine-associated "H100" is available but it appears from the minimal chatter here that no one has much good to say about it. Is that about right?

Back in the day (circa 2002 when I first got Peyronies Disease) Topical Verapamil was supposed to be the "shining hope." I finally got a doctor to give me a prescription, tried it for a while, but can't say I attribute any improvements I had to it. And it's largely become the exemplar of "flash in the pan" treatments, though I note Peyronies Disease Labs is still in business, so someone must be using it.

Is H100 the newest version of TV? Just curious. I would have thought with the widely respected Dr. Levine associated, it would have been a more substantial development.

Nemo
51 yrs. old, multiple auto-immune conditions. First episode of Peyronies Disease in 2002. Recurred a couple times since. Over the years I have tried Topical Verapamil, Iontophoresis, all the supps and Cialis + Pentoxifylline. Still functional, always worried.

howtheheck

Hi Nemo,

I actually restarted a similar post a few days ago on this topic.  It seems Dorian is coming up on 3 months taking it and will continue.  If I get my hands on it while in the acute stage (which is what it is only recommended for) I would do the same.  Either way a commitment of 6 months minimum and being in the acute stage are needed to get an accurate review.  I am not sure if others who have taken it actually did this.

https://www.peyroniesforum.net/index.php/topic,14735.msg142860.html#msg142860
56 years old.  Westerner (Expat) living in China, Single, 4/21 start. Various natural topicals & orals, will use home ESWT machine.  05/24 started TCM with TCM herbs acupuncture.  06/02/21- Restorex, also noticed slight dorsal curve late 06/21

howtheheck

Am I reading this correctly?  This company will be marketing H100 globally.  So, all the non-Americans here in Acute stage might have a chance to obtain.  However even much more importantly....someone else read this and see if you agree with this statement...they are going to do their own clinical trials on this before they start offering globally?

https://irdirect.net/prviewer/release_only/id/4926633
56 years old.  Westerner (Expat) living in China, Single, 4/21 start. Various natural topicals & orals, will use home ESWT machine.  05/24 started TCM with TCM herbs acupuncture.  06/02/21- Restorex, also noticed slight dorsal curve late 06/21

FlatteningTheCurve

Unless H100 has changed recently, I believe the answers to your questions are:

- Yes, not many people have anything positive to say about H100, I have not read any statement saying it actually helped their case

- No, H100 is not that new, I have at least read about it for a few years

- No, it is not a new version of topical Verapamil, it is a different substance

Any topical application that is prescribed seems to have very minor, if any, evidence of leading to improvements in terms of Peyronies Disease. Uroweb states:

"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."

In other words, whether it is offered globally or not, I would not jump on the opportunity to pay for H100 but that is just me. Apologies if I sound like a negative Nancy but I am just very sceptical of these things, did not mean to rain on your parade!
Early 30s, diagnosed with Peyronies in 2017 after trauma during sex. ca 15 degrees upward curvature. Restorex, VED, 5mg Cialis, Pentox, L-arginine, Coq10, Propolis, Vitamin E. Underwent 12 rounds of Verapamil injections 2021-22

howtheheck

you're not raining on my parade by any means.  However I spend much time like others on this site, and I challenge anyone to find more than 2-3 people here who have taken H100, only in the acute stage, and took it for the full 6 months.  If only a few who pass that criteria say it did not work, it is still not a negative sign.  I mean...you can also find 2-3 people on this forum who say Castor Oil is a miracle drug:).  I will say, people do jump on the bandwagon that it is not good because it is related to Verapamil and have never tried it, but just talk down about it.

The important thing is they are not going to do a small 10-20 person trial, rather they are going for FDA approval.  After reading further into their SEC reports of all the risks (required by law to report) of it not working, there is a chance it may not work.  However I don't know of any other drug that is used for Peyronies that is going for FDA approval.  Below is a partial risk assessment that I C&P from their SEC statement.   Bad news...all of us active on this site will be well past the acute stage by then.  $14M+ to prove that it is worthy drug...if you are in the acquisition team of this company, you should do your homework/research before they are willing to pay for these expenses and feel they have a high chance of succeeding.  Maybe they will also tweak the formula as well- who knows.  

"The Company also expects to incur approximately $14 million of research and development expenses relating to H100™ over the estimated four to six year period of clinical development prior to FDA approval, including approximately $10 million for clinical trial"
56 years old.  Westerner (Expat) living in China, Single, 4/21 start. Various natural topicals & orals, will use home ESWT machine.  05/24 started TCM with TCM herbs acupuncture.  06/02/21- Restorex, also noticed slight dorsal curve late 06/21

FlatteningTheCurve

Hey,

Yeah fair point regarding castor oil, you're right that people praise all kinds of different things on the forum that works for them, but that is not the same as scientific evidence.

I guess the point I was trying to make is that topical treatments such as H100 or topical Verapamil are neither recommended by urologists nor cited anecdotally as useful on the forum. The main point for me is that Uroweb cites four different studies that fail to provide evidence of H100 being useful for Peyronies Disease patients. At the same time, these topical substances tend to be quite expensive which makes for a bad tradeoff, which might be why so few patients choose to pay for something that costs a lot and where the positive effects are minimal if any. Thus, I would not get my hopes up for this new study.

That said, I am all in favour of more studies on the topic and IF it turns out that topical H100 would be useful for men in the acute phase that would be great. I am not against gathering more evidence on what is useful to treat Peyronies Disease. This is especially the case with studies involving a larger sample of patients, the more robust findings the better.

Early 30s, diagnosed with Peyronies in 2017 after trauma during sex. ca 15 degrees upward curvature. Restorex, VED, 5mg Cialis, Pentox, L-arginine, Coq10, Propolis, Vitamin E. Underwent 12 rounds of Verapamil injections 2021-22

howtheheck

Well if anyone is looking to try H100, you would have to be involved in the future FDA trials.  I just contacted the exclusive Pharmacy that compounds this and they say that because of impending FDA trials they are no longer allowed to sell this product.  
56 years old.  Westerner (Expat) living in China, Single, 4/21 start. Various natural topicals & orals, will use home ESWT machine.  05/24 started TCM with TCM herbs acupuncture.  06/02/21- Restorex, also noticed slight dorsal curve late 06/21