Futura Medical Share Discussion Threads

[2 solaris] 15/3/2024 10:01

Balmy posts here all the time now as idiots respond to trolls when they could easily use the filter button. Post your drivel elsewhere please.

[onedayrodders] 15/3/2024 08:15

Nice tennis match going on here

:O(

[petroc] 14/3/2024 18:35

Tsk tsk. You managed to reply in six minutes, but the correct response should have been 'How high?'

[mdi] 14/3/2024 15:59

No evidence exists from any double blind study that the non medicated ‘Dermasys’ hydroalcoholic gel works any better then just using any other similar non medicated hydroalcoholic gel. Others have already shown that it was proven years ago any non medicated placebo hydroalcoholic gel can have similar effects on erectile function ‘progressively improved over a period of at least 12 weeks’



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

[petroc] 14/3/2024 15:52

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.

[mdi] 14/3/2024 14:14

Eroxon is not ‘clinically proven’ to have any effect beyond a similar placebo gel in any double blind study



Eroxon ‘is a placebo’



Researchers call for stricter rules on drug-like medical devices

More oversight is needed over products in the grey area between medical device and medication

Powders, tablets and gels used like medications but registered as medical devices the same category plasters and pacemakers fall into need tighter controls, a team of clinical researchers has concluded after studying several such materials. Products that fall into this regulatory grey zone dont need to prove their efficacy or safety in the same way pharmaceuticals do, which could be a concern for vulnerable patients

According to European regulations, medical devices are used for diagnosis, prevention or treatment of disease, but unlike drugs their primary mode of action isnt biological. The definition includes everything from medical software to wound dressings and surgical instruments

Manufacturers need to demonstrate medical devices safety and performance. An organisation called a notified body then assesses the products conformity and grants it a CE mark. But Van Winckel and her colleagues found only poor clinical evidence for the three devices they investigated. Studies were small or of low quality, often missing placebo controls. In some cases, there was no data at all, for example to show the effect

The researchers also highlighted the lack of safety information in the devices instruction leaflets. There was no or little mention of interactions with other compounds, maximum safe dose or adverse effects



Oral powders or gels, sold as medical devices in the European Union (EU), arent regulated to the same safety standards as those applied to medicines

As a result, these products, which look like medicines, can be marketed with very limited clinical data and accompanied by poor quality product information.

require only certification with a CE (quality) kitemark before the product can be marketed.

This process doesnt require evidence of efficacy or safety from high quality clinical trials, as is the case for medicines.

It also means that these products can automatically be sold without a prescription across the EU, and actively marketed to patients and clinicians.

[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.