New ED Treatments In the Pipeline

[Alex-Dys]

Hello men!

Has anyone recently investigated the new ED gel planned to next year?

The pharm firm that is coming out with this is Futura Medical. It's a British company and they have had excellent clinical trials responses. the product is Dermasys, formerly MED2005 and MED3000. Do an internet search on the company, and then on Dermasys and teh oters.

Be sure to select from the google tools drop-down Any time, and choose from 2019. This will give you the latest info on any search.

Another is the lab-synthesized extract from the Brazilian Wandering spider's venom. Search for PnPp-19, and BZ317.

I know the Dermasys has been touched on in this portal, but those are older postings. Truth is the pharm company is now starting conversations with the FDA. Read how this will not have any "active medication" thus getting it passed the FD relatively quickly.

I encourage everyone to read these things; they sound exciting.

[Simbarn]

Very interesting. Thank you.
Here is a link to a full text study I found on MED 2005,for anyone wanting to understand more.
https://www.sciencedirect.com/science/a ... 9517318520

[DaveKell]

I nearly decided to pass on being implanted to wait for the wandering spider venom ED med to come to market. Early testing was done on aged, obese, and diabetic impotent male rats. The formerly incapable rats bred several new generations with no apparent health setback issues. The protein responsible for the erection men got after being bitten by the spider was synthesized separate from the usually lethal aspect of the venom. The last thing I read was that human trials are still years away. The erections produced by the synthesized protein lasts around 2 hours. The exciting aspect of this is that it works within 10 minutes without fail every time. You can see why I almost waited for it. As it is, I think my marriage was saved with an implant and I’ve been having incredible sex for almost 3 years now. I could’ve easily been a miserable single guy waiting for a pie in the sky treatment to be approved.

[username_taken29]

I nearly decided to pass on being implanted to wait for the wandering spider venom ED med to come to market. Early testing was done on aged, obese, and diabetic impotent male rats. The formerly incapable rats bred several new generations with no apparent health setback issues. The protein responsible for the erection men got after being bitten by the spider was synthesized separate from the usually lethal aspect of the venom. The last thing I read was that human trials are still years away. The erections produced by the synthesized protein lasts around 2 hours. The exciting aspect of this is that it works within 10 minutes without fail every time. You can see why I almost waited for it. As it is, I think my marriage was saved with an implant and I’ve been having incredible sex for almost 3 years now. I could’ve easily been a miserable single guy waiting for a pie in the sky treatment to be approved.

Very excited to hear about dermasys more

[Flavio]

Hello men!

Has anyone recently investigated the new ED gel planned to next year?

[...]

Yes, we've already discussed it here and it shows great promise.

No side effects, more efficacy, more spontaneity: what's not to like?!

Let's hope the covid-19 crisis doesn't delay this, I can't wait to try the new gel.

[erik821]

Not to be a buzzkill but Dermasys/MED3000 is a non-pharma product and if approved will be sold over the counter which tempers my excitement straight away. Always need a script for anything truly effective unfortunately. The major issue I see with this product is that the placebo results were nearly the same as those given the non-placebo which is not a home run. During Pfizer's clinical trials back in the day there was clear difference with Viagra and placebos. I'm skeptical that this is a lot of fanfare for a pie-in-the-sky product that will end up in convenience stores next to all the other male enhancement products readily available to the general public. There is big money to be made for a company to generate legitimate buzz and to put a new ED product on the market. Stock price skyrockets amid the initial hype and the owner sells his shares and closes up shop in a timely fashion, walking away a billionaire for marketing a topical gel/liquid with a max amount of nitroglycerin not to exceed FDA requirements for an OTC product. That's how people who are smart get wealthy and I'm sure this product has been years in the making it didn't happen by accident.

Futura lost half their money after this clinical trial. Fifty percent of their investors said they wanted out.


Phase III trial
The December 10 update delivered what can best be described as a set of nuanced results. For while MED2005 (DermaSys + GTN) showed strong efficacy, excellent safety, rapid speed of onset, the placebo had a “highly statistically significant” impact on the men in the control group of the experiment.

Normally, a placebo is a sugar pill, liquid or gel with no medical benefit whatsoever. However, in the Futura clinical assessment, researchers used DermaSys as the supposed inert substance. As Futura said the results from the control group were highly statistically significant, this would tend to rule out a small lift sometimes observed called the placebo effect.

The outcome meant that while MED2005 scored well on most trial elements (efficacy, safety, and speed of onset), it failed to meet its clinical endpoint of being statistically superior to the placebo gel.

That’s not to say the trial, or the technology was a failure. According to Futura, its regulatory submission has become simpler thanks to the rather odd outcome. For instead of submitting the MED2005 combination for scrutiny by the watchdogs, the firm intends to submit just the DermaSys part of the formulation for approval. In doing so, it will put DermaSys forward as a medical device rather than a pharmaceutical product.

https://www.morningstar.co.uk/uk/news/A ... ilure.aspx

[username_taken29]

Thanks Erik...pardon my ignorance but was the med3000 actually compared to a placebo which was just the dermasys? If the results were not stat significant, then that means the efficacy of both are actually quite similar? I may be misreading the below.

Not to be a buzzkill but Dermasys/MED3000 is a non-pharma product and if approved will be sold over the counter which tempers my excitement straight away. Always need a script for anything truly effective unfortunately. The major issue I see with this product is that the placebo results were nearly the same as those given the non-placebo which is not a home run. During Pfizer's clinical trials back in the day there was clear difference with Viagra and placebos. I'm skeptical that this is a lot of fanfare for a pie-in-the-sky product that will end up in convenience stores next to all the other male enhancement products readily available to the general public. There is big money to be made for a company to generate legitimate buzz and to put a new ED product on the market. Stock price skyrockets amid the initial hype and the owner sells his shares and closes up shop in a timely fashion, walking away a billionaire for marketing a topical gel/liquid with a max amount of nitroglycerin not to exceed FDA requirements for an OTC product. That's how people who are smart get wealthy and I'm sure this product has been years in the making it didn't happen by accident.

Futura lost half their money after this clinical trial. Fifty percent of their investors said they wanted out.


Phase III trial
The December 10 update delivered what can best be described as a set of nuanced results. For while MED2005 (DermaSys + GTN) showed strong efficacy, excellent safety, rapid speed of onset, the placebo had a “highly statistically significant” impact on the men in the control group of the experiment.

Normally, a placebo is a sugar pill, liquid or gel with no medical benefit whatsoever. However, in the Futura clinical assessment, researchers used DermaSys as the supposed inert substance. As Futura said the results from the control group were highly statistically significant, this would tend to rule out a small lift sometimes observed called the placebo effect.

The outcome meant that while MED2005 scored well on most trial elements (efficacy, safety, and speed of onset), it failed to meet its clinical endpoint of being statistically superior to the placebo gel.

That’s not to say the trial, or the technology was a failure. According to Futura, its regulatory submission has become simpler thanks to the rather odd outcome. For instead of submitting the MED2005 combination for scrutiny by the watchdogs, the firm intends to submit just the DermaSys part of the formulation for approval. In doing so, it will put DermaSys forward as a medical device rather than a pharmaceutical product.

https://www.morningstar.co.uk/uk/news/A ... ilure.aspx

[erik821]

MED3000 is the name of the actual gel. Dermasys is the name they have given the transdermal delivery system. It's basically one and the same.

Think of it this way using hand lotion as an example:

Lotion name = Aveeno
Active ingredient: Shea Butter

ED Product = Dermasys
Active (proprietary) ingredient: MED3000

MED3000 is essentially a nitroglycerin product and they won't even be looking for FDA approval anymore on that side of things. More than likely because it has been found to exhibit no new pharmaceutical implication or relevance to the extent that it actually needs approval. Nitroglycerin is already sold OTC for things like angina and anal fissures. The "Dermasys" piece is a transdermal delivery system of what basically amounts to distilled water and isopropyl alcohol which will be much easier to get FDA approval on as a "medical device" and that speeds up marketing and makes actually making money on their product a viable thing.

You could probably buy some .02 strength nitroglycerin at a drug store and mix it with water and a little rubbing alcohol and voila. Same thing.

Anyway, the placebo gel had almost the same effect as the MED3000 (nitro). When investors saw that data they weren't happy and started ditching their shares and the company lost half its stock price.

EDIT: Futura actually lost about 2/3. The stock went from $29 GBX on 12/9/19 to $10 GBX on 12/13/19.

Had you bought it in May 2016 at $16 a share you could have done well. It skyrocketed to over $80 per share in early Sep of that same year before taking a nosedive. That's a high of $80 to a low of $10 over the span of 3.5 years. Ouch.

[username_taken29]

Got it, thx for the detail.

MED3000 is the name of the actual gel. Dermasys is the name they have given the transdermal delivery system. It's basically one and the same.

Think of it this way using hand lotion as an example:

Lotion name = Aveeno
Active ingredient: Shea Butter

ED Product = Dermasys
Active (proprietary) ingredient: MED3000

MED3000 is essentially a nitroglycerin product and they won't even be looking for FDA approval anymore on that side of things. More than likely because it has been found to exhibit no new pharmaceutical implication or relevance to the extent that it actually needs approval. Nitroglycerin is already sold OTC for things like angina and anal fissures. The "Dermasys" piece is a transdermal delivery system of what basically amounts to distilled water and isopropyl alcohol which will be much easier to get FDA approval on as a "medical device" and that speeds up marketing and makes actually making money on their product a viable thing.

You could probably buy some .02 strength nitroglycerin at a drug store and mix it with water and a little rubbing alcohol and voila. Same thing.

Anyway, the placebo gel had almost the same effect as the MED3000 (nitro). When investors saw that data they weren't happy and started ditching their shares and the company lost half its stock price.

EDIT: Futura actually lost about 2/3. The stock went from $29 GBX on 12/9/19 to $10 GBX on 12/13/19.

Had you bought it in May 2016 at $16 a share you could have done well. It skyrocketed to over $80 per share in early Sep of that same year before taking a nosedive. That's a high of $80 to a low of $10 over the span of 3.5 years. Ouch.

[username_taken29]

Not to be a buzzkill but Dermasys/MED3000 is a non-pharma product and if approved will be sold over the counter which tempers my excitement straight away. Always need a script for anything truly effective unfortunately. The major issue I see with this product is that the placebo results were nearly the same as those given the non-placebo which is not a home run. During Pfizer's clinical trials back in the day there was clear difference with Viagra and placebos. I'm skeptical that this is a lot of fanfare for a pie-in-the-sky product that will end up in convenience stores next to all the other male enhancement products readily available to the general public. There is big money to be made for a company to generate legitimate buzz and to put a new ED product on the market. Stock price skyrockets amid the initial hype and the owner sells his shares and closes up shop in a timely fashion, walking away a billionaire for marketing a topical gel/liquid with a max amount of nitroglycerin not to exceed FDA requirements for an OTC product. That's how people who are smart get wealthy and I'm sure this product has been years in the making it didn't happen by accident.

Futura lost half their money after this clinical trial. Fifty percent of their investors said they wanted out.


Phase III trial
The December 10 update delivered what can best be described as a set of nuanced results. For while MED2005 (DermaSys + GTN) showed strong efficacy, excellent safety, rapid speed of onset, the placebo had a “highly statistically significant” impact on the men in the control group of the experiment.

Normally, a placebo is a sugar pill, liquid or gel with no medical benefit whatsoever. However, in the Futura clinical assessment, researchers used DermaSys as the supposed inert substance. As Futura said the results from the control group were highly statistically significant, this would tend to rule out a small lift sometimes observed called the placebo effect.

The outcome meant that while MED2005 scored well on most trial elements (efficacy, safety, and speed of onset), it failed to meet its clinical endpoint of being statistically superior to the placebo gel.

That’s not to say the trial, or the technology was a failure. According to Futura, its regulatory submission has become simpler thanks to the rather odd outcome. For instead of submitting the MED2005 combination for scrutiny by the watchdogs, the firm intends to submit just the DermaSys part of the formulation for approval. In doing so, it will put DermaSys forward as a medical device rather than a pharmaceutical product.

https://www.morningstar.co.uk/uk/news/A ... ilure.aspx

Erik, I read the study again and it seems like dermasys still produced statistically significant results.....so I think this should be a very positive sign.