Futura Medical Share Discussion Threads

[mdi] 18/3/2024 10:26

Auxilium Pharmaceuticals can also get their non medicated placebo hydroalcoholic gel cleared via the 510k pathway as a ‘clinically proven’ medical device.





Researchers found that, over 14 weeks, men who were randomly assigned to take Viagra plus testosterone gel did no better than those given the drug plus a hormone-free placebo gel.

Overall, men in both groups responded to the drug, Spitzer said.

On average, the men's score on a standard set of erectile dysfunction questions increased by about 8 points removing them up to the "mild" erectile dysfunction category. And there was no substantial difference between men who used the testosterone gel and those who used the placebo



Testim® (testosterone gel) is a clear to translucent hydroalcoholic topical gel

Inactive ingredients in Testim are purified water, pentadecalactone, carbopol, acrylates, propylene glycol, glycerin, polyethylene glycol, ethanol (74%), and tromethamine

[glavey] 18/3/2024 05:55

Erexon: 335 out of 429 (78%) reviewers recommend this product

Eroxon: 342 out of 456 (75%) reviewers don't recommend this product

[mdi] 17/3/2024 19:14

Any similar Hydroalcoholic gel made of the same main ingredients as Eroxon. Alcohol, water and glycol causes evaporative cooling. And other placebo hydroalcoholic gels have already been ‘clinically proven’ to work in many other ED studies. So they can all now seek marketing clearance via the 510k pathway as similar equivalent non medicated class 2 medical device gel treatments for ED.



‘In hydroalcoholic gels, the solvent evaporates quickly’



Preferred solvents in use in ATD technology are alcohols, glycols and glycol ethers.

Following evaporation of the solvents, thermodynamic activity in the residual vehicle (glycols, glycol ethers and water) is increased



Men were first treated with tadalafil 10 mg once a day (OAD) for 4 weeks; if not successful, they were randomized in a double-blind, placebo-controlled design to receive placebo or a 1% hydroalcoholic T gel (50 mg/5 g gel)

Erectile function progressively improved over a period of at least 12 weeks in both the placebo and T treatment groups

[mdi] 17/3/2024 17:43

‘a non-medicated hydro-alcoholic gel indicated for treatment of erectile dysfunction in adult males aged 22 years and over. Upon application, the volatile components of the formulation (alcohol and water) evaporate’

‘De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing criteria called special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for devices of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device

The average length of time for clearance under the traditional 510(k) pathway is 177 days,



a company must compare their product to one already cleared by the FDA and provide evidence that their product is substantially equivalent to the previously cleared (legally marketed) device. To be substantially equivalent, the product must meet criteria for the same intended use, have the same technology or (slightly) different technology but produces similar end results, and be safe and effective. Once pre-market clearance is received from the FDA the device can be distributed commercially immediatelyââ

[mdi] 17/3/2024 17:14

Besins too can submit to get the pharmacologically inactive ingredients of their hydroalcoholic gel cleared in a matter of days via the 510k pathway as an equivalent non medicated evaporative cooling medical device gel ‘clinically proven’ to treat ED. Its already FDA approved delivering Testosterone.





Manufactured by Laboratoires Besins Iscovesco

AndroGel (testosterone gel) 1% is a clear, colorless hydroalcoholic gel containing testosterone.

Pharmacologically inactive ingredients in AndroGel 1% are carbomer 980, ethanol 67.0%, isopropyl myristate, purified water, and sodium hydroxide. These ingredients are not pharmacologically active.



Researchers found that, over 14 weeks, men who were randomly assigned to take Viagra plus testosterone gel did no better than those given the drug plus a hormone-free placebo gel.

Overall, men in both groups responded to the drug, Spitzer said.

On average, the men's score on a standard set of erectile dysfunction questions increased by about 8 points “moving them up to the "mild" erectile dysfunction category. And there was no substantial difference between men who used the testosterone gel and those who used the placebo.

[mdi] 17/3/2024 16:08

Another similar hydroalcoholic gel vehicle from Besins Healthcare. It too can now be cleared via the 510k pathway as a ‘clinically proven’ non medicated placebo medical device for ED







‘In hydroalcoholic gels, the solvent evaporates quickly’

[broomrigg] 17/3/2024 15:44

MDI - 09 Sep 2016 - 12:08:41 - 832 of 13278........

"What a week it has been for Futura Medical, which has more than tripled in value after unveiling some quite impressive results for a new gel it has developed for erectile dysfunction (see I got all the way through that sentence without a schoolboy pun).

It now has a product that can challenge pill-based treatments such as Viagra and Cialis in this $5billion a year market.

Crucially, Futura's gel, to be branded Eroxon, acts in as little as five minutes, where the little blue pill might take up to half an hour."

[broomrigg] 17/3/2024 15:43

MDI 26 Feb '15 - 08:41 - 46 of 13267........

"Yeah and the systemic side effects of Viagra are very mild!? Dry mouth, facial flushing etc. never mind the new cancer concerns associated with Viagra. And it's definitely a drug your doctor would not advise you take OTC and buy online. Just hope you don't get sent the ones with rat poison mixed into them from some back street factory. But if you are willing to use rubber bands to get an erection then I am sure a bit of blue rat poison won't hurt either? Maybe it will kill the STDs from also not using a condom!"

[mdi] 17/3/2024 14:18

Both Dermasys and ATD cause the same evaporative cooling





Eroxon® contains ethanol, propylene glycol

Dermasys is a drug delivery technology platform that provides rapid and targeted local delivery of active pharmaceutical ingredients (API) at therapeutic levels to the required site of action

application of gel with API leads to a combination of solvents including volatile solvents then volatile solvents evaporate, leaving the remaining solvent supersaturated with API in turn, derives API through the tissue and then API penetrated the skin rapidly offering rapid penetration or sustained release




Antares Pharma has developed and patented Advanced Transdermal Delivery (ATD™) technology, which is based on a combination of solvents and compounds that enhance the permeation of API through the skin.

The most commonly used solvents in ATD™ technology are alcohols, glycols and glycol ethers.

Following evaporation of the solvents,thermodynamic activity in the residual vehicle (glycols, gly-col ethers and water) is increased

[mdi] 17/3/2024 10:59

Costs less then $30k for anyone to get marketing clearance for another similar placebo non medicated hydroalcoholic gel device for ED via the 510k route.



The vast majority of our FDA 510K clients generally spend in the range of $20,000-$30,000 to have their product or device prepared and reviewed before the actual FDA 510k submission process.

One of the positive sides to seeking a FDA 510K approval for a new medical product, whether tested or untested, is that if there is already a similar FDA approved product being marketed, then the FDA will have to approve any new products that are almost the same as the product that is already FDA 510 K approved and have under gone all required testing, documentation, and registration processes.

[takeiteasy] 17/3/2024 10:58

In the first part of our research, we were interested in exploring whether the pull of the rabbit hole would grow stronger or weaker once people had already viewed several videos. We had participants view either five different music videos or just one music video, and then we asked them if they’d rather watch another video or complete a work-related task. In theory, one might expect that people would get tired of watching music videos after watching five in a row, reducing their desire to watch more of them. But in fact, we found that the opposite was true: Watching five videos made people 10% more likely to choose to watch an additional music video than if they only watched one video.

Clearly, seemingly small details around the order and types of content we consume can have a major impact on our decision to keep consuming similar content. But what drives this effect? Prior research suggests that the three factors we identified all increase the accessibility of similar media. In this context, accessibility refers to how familiar, or top-of-mind, a given kind of content feels. When something feels more accessible, it becomes easier to process, leading us to anticipate that we will enjoy it more. In other words, people choose to continue down the rabbit hole because viewing related media “feels right” — even if it’s at odds with what they actually want to be doing, whether that’s getting work done or even just taking a break.

Probably the most relevant piece of research for this thread you will ever read....I will never ever post an FUM piece because it will most likely never be understood.

hxxps://hbr.org/2022/01/the-psychology-of-your-scrolling-addiction

[mdi] 16/3/2024 19:41

Sanofi can do the same under the Cialis together brand and launch their own ‘clinically proven’ medical device non medicated hydroalcoholic gel OTC in a few days. A non medicated Cialis gel too would be as safe as Eroxon and similar side effects as both would only contain the similar evaporative cooling ingredients of Alcohol, water and glycol.





Men were first treated with tadalafil 10 mg once a day (OAD) for 4 weeks; if not successful, they were randomized in a double-blind, placebo-controlled design to receive placebo or a 1% hydroalcoholic T gel (50 mg/5 g gel)

Erectile function progressively improved over a period of at least 12 weeks in both the placebo and T treatment groups

[mdi] 16/3/2024 19:25

So a Viagra branded non medicated medical device gel based on the Antares ATD hydroalcoholic gel technology could be cleared via the 510k route in days and would be ‘clinically proven’ to safely increase the effects of Oral Viagra.



‘New Jersey-based Antares is partnered with Pfizer’



Researchers found that, over 14 weeks, men who were randomly assigned to take Viagra plus testosterone gel did no better than those given the drug plus a hormone-free placebo gel.

Overall, men in both groups responded to the drug, Spitzer said.

On average, the men's score on a standard set of erectile dysfunction questions increased by about 8 points “moving them up to the "mild" erectile dysfunction category. And there was no substantial difference between men who used the testosterone gel and those who used the placebo

[mdi] 16/3/2024 16:37

‘De Novo authorization will also allow subsequent devices of the same type and intended use to come to the market through the 510k pathway, which could enable the devices to get on the market faster’



the average time to issue a decision in 2021 was 147 days according to FDA data.

For the year up to the end of September 2022, 85 percent of 510(k) applications were issued with a Substantially Equivalent decision from the FDA. A Substantially Equivalent decision means the product has regulatory approval to be sold in the US market.



About ATDTM Gel Technology

ATDTM Gel Technology is a hydroalcoholic transdermal gel containing less than 50 percent ethanol and a patented mixture of penetration enhancers.



Preferred solvents in use in ATD technology are alcohols, glycols and glycol ethers.

Following evaporation of the solvents, thermodynamic activity in the residual vehicle (glycols, glycol ethers and water) is increased

Antares Pharma’s ATDTM (advanced transdermal delivery) technology is based on hydroalcoholic gels

The formulation causes neither irritation nor occlusion of the skin after the application. Clinical trials involving several hundreds of patients and using different drugs have demonstrated excellent skin tolerability.