Futura Medical Share Discussion Threads

[mdi] 14/3/2024 11:27

Eroxon was ‘clinically proven’ by FM71 to be less effective then the lowest possible dose of Tadalafil.

Tadalafil has been ‘clinically proven’ more effective then oral placebos in double blind studies.

Eroxon has never been ‘clinically proven’ to be more effective then a similar placebo gel in any double blind study.



Does it work?

MED3000 was recently granted a CE mark as an approved medical device in the EU. Does this mean it works? No. Unlike drugs, medical devices don't need to be proven efficacious to be sold; they only need to show conformity with safety regulations, which the CE mark indicates.



‘approval for a medical device might skip some checks and balances necessary for a drug approval. The gold standard for testing the gel would be a placebo-controlled study’


In placebo-controlled clinical studies, the discontinuation rate due to adverse reactions for Viagra (2.5%) was not significantly different from placebo (2.3%).

Serious side effects are rare and happen in less than 1 in 1,000 people. Common side effects of sildenafil happen only in more than 1 in 100 people.If you're taking it for erection problems you're unlikely to get side effects as you're only taking it for a short time.

Some of the men in the placebo arm of Viagra studies also reported many of the same common side effects including headaches, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, rash, dizziness. Even in FM57 men also reported side effects like headaches and even burning from using the placebo Eroxon gel.





˜Viagra was significantly more effective than placebo in all studies’

[petroc] 13/3/2024 18:42

Eroxon is approved as a medical device in the EU and was launched in March and April 2023 in certain countries in Europe with more countries to follow. It becomes the first clinically proven, pan-European OTC topical treatment for erectile dysfunction available without a doctor’s prescription.

The EU authorisation paves the way for approval in many countries around the world, including in Latin America, the Middle East, Africa and the Far East regions, with many countries considering “fast-track" review based on recognition of the EU CE mark. Marketing authorisation has now been received in five Middle Eastern countries with more to follow.

Eroxon is a unique and highly differentiated easy to use topical gel for erectile dysfunction which has Phase 3 clinical data demonstrating highly statistically significant improvement across all ED severities.

[petroc] 13/3/2024 18:38

The efficacy of Eroxon® is remarkable and has been shown to deliver clinically meaningful benefits to most sufferers with erectile dysfunction in two Phase 3 studies but with significantly lower adverse events than current first line therapy. With topical application, it will be of particular appeal to mild to moderate ED patients who want a fast onset of action. Lack of drug interactions with prescription products will enable the product to be used with other medications such as nitrates and other cardiovascular drugs. As such the product will be of great interest to the medical community.

[mdi] 13/3/2024 13:32

Futura used the ‘least burdensome approach’ of a De novo medical device application.



This approach only requires a low class medical device to meet the threshold of ‘reasonable assurance’ of some effect including the effect just being a placebo effect. Eroxon still has not been ‘clinically proven’ to have any effect beyond a similar placebo gel in any fully blinded study. A standard that all PDE5i drugs meet.



Devices are subject to weaker standards than drugs because they are regulated under a different law. The Medical Device Amendments of 1976 was intended to encourage innovation while allowing for a range of review standards based on risk, according to legal expert Richard A. Merrill. An array of corporate lobbying has since prompted Congress to ease regulations and make it easier for devices to get the FDA OK

Journalists need to scrutinize the claims.

Journalists have a responsibility to report this lack of evidence, but they often dont. Investigative journalist Jeanne Lenzer, who wrote a book about the under-regulated medical device industry, says more dogged reporting is needed: We really dont know what we are getting with many of these devices

Ninety-nine percent of devices never have to provide clinical data, thanks in part to the 2002 Medical Devices User Fee Act, which requires the FDA to use the least burdensome route

For the few devices subject to a scientific review, the quality standards are flimsy. Randomized controlled trials, the gold standard, are infrequent. Most studies are unblinded, and thus prone to bias. The FDA settles for loosely defined reasonable assurance that a device is safe and effective, versus its higher standard of substantial evidence for drugs, which require studies with comparison groups that didnt receive the same treatment. Thus, data that would never be sufficient to support the approval of a drug can result in the approval of a device used to treat the same condition, potentially diverting patients from effective drugs to less-effective devices.

[mdi] 13/3/2024 11:56

FM57 was not a placebo controlled study of Eroxon. It was a study of a different compound called Med2005 in which Eroxon was the placebo gel.



The company that makes MED3000 (Eroxon) also made a different compound called MED2005, a nitroglycerine-containing cream. Two trials have been completed, but only one was published. In the published trial, the results showed that the results for the active drug were only marginally better than a placebo, with about 37% of placebo recipients being satisfied with their experience versus 48% in those who received the active drug.

This means that about one man out of nine who used the active drug found it more helpful than a placebo. It also means that most people who were satisfied with the results were having a placebo response

The company then decided to market the placebo compound itself as Eroxon, which does not contain nitroglycerine or any compound that is expected to have a pharmacologic effect, although the company suggests that the “evaporative effect” of the cream may stimulate nerve endings, without any data to support this.



There is no evidence for the evaporative mode of action from the clinical trials. To show that the evaporation is what makes MED3000 work, you'd need to compare it to a non-evaporative gel.

[petroc] 13/3/2024 10:22

Watch this, MDI:

[mdi] 12/3/2024 22:12

Does it work?

MED3000 was recently granted a CE mark as an approved medical device in the EU. Does this mean it works? No. Unlike drugs, medical devices don't need to be proven efficacious to be sold; they only need to show conformity with safety regulations, which the CE mark indicates.



‘approval for a medical device might skip some checks and balances necessary for a drug approval. The gold standard for testing the gel would be a placebo-controlled study’


In placebo-controlled clinical studies, the discontinuation rate due to adverse reactions for Viagra (2.5%) was not significantly different from placebo (2.3%).

Serious side effects are rare and happen in less than 1 in 1,000 people. Common side effects of sildenafil happen only in more than 1 in 100 people.If you're taking it for erection problems you're unlikely to get side effects as you're only taking it for a short time.

Some of the men in the placebo arm of Viagra studies also reported many of the same common side effects including headaches, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, rash, dizziness. Even in FM57 men also reported side effects like headaches and even burning from using the placebo Eroxon gel.





‘Viagra was significantly more effective than placebo in all studies’

[mdi] 12/3/2024 13:23

'30%-54%' reduction in Alzheimers if you use Sildenafil 'than those who did not after adjusting for potential confounding factors'hTtps://www.medscape.com/viewarticle/new-data-support-viagra-alzheimers-prevention-2024a10004mdA new study provides more evidence that sildenafil (Viagra) which is used to treat erectile dysfunction (ED) may help protect against Alzheimer's disease (AD).The large real-world analysis of patient data from two databases showed a 30%-54% reduced prevalence in AD among patients who took sildenafil (Viagra) than those who did not, after adjusting for potential confounding factors.This observation was further supported by mechanistic studies showing decreased neurotoxic protein levels in brain cells exposed to the phosphodiesterase type 5 inhibitor (PDE5i).