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CUV, CLINUVEL PHARMACEUTICALS LIMITED
LevelHeaded2000
post Posted: Oct 16 2019, 03:47 AM
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In Reply To: Kalaz's post @ Oct 16 2019, 03:31 AM

I believe it was actually a phase 3 and a trial that is a few years old. I looked into before, but I didn't bookmark it unfortunately. It was a second phase 3 in europe I believe.


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Kalaz
post Posted: Oct 16 2019, 03:31 AM
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I cannot get on Clinuvel website right now, it may be down.
Can anyone tell me when phase 4 was completed? Was it just before approval?

 
LevelHeaded2000
post Posted: Oct 16 2019, 03:06 AM
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Btw, this gives a pretty good list of various skin therapies related to scenesse: https://www.skintherapyletter.com/dermatology/afamelanotide/

I could see acne being the target of a potential OTC. It may not require too much active ingredient to penetrate the skin into the blood and as a result would be a good candidate for an OTC (which has more rules than an rx about what is allowed). No idea if it would still be effective for acne based on that, but it seems like a good chance considering acne happens at the pore level and the mechanism of action is inflammation reduction.


Lastly, I think there is a HUGE business in rx-based topical cremes. Even if an OTC topical that causes a tan is not released in the next couple years there is a LOT of skin diseases that would benefit from an rx-based anti-inflammatory based on scenesse.

It is not like getting an rx is hard. Hell, insurance even pays for the drug as an rx. So, ignoring the OTC, just getting a topical will be HUGE news period even if it requires an rx.


 
blackm3
post Posted: Oct 16 2019, 03:04 AM
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In Reply To: Justinian's post @ Oct 16 2019, 02:26 AM

We can also expect ( in time when clinuvel decides) for the delivery method of scenesse to be relaxed... the implant method should be short lived

 
LevelHeaded2000
post Posted: Oct 16 2019, 02:56 AM
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In Reply To: Justinian's post @ Oct 16 2019, 02:26 AM

Agreed. I view the OTC as a completely separate business. Likely Clinuvel is just leveraging it's brand and the fact that it is an FDA / EMA approved dermatology company to lend credibility to it's OTC lineup and increase brand positioning in consumers minds. I do not think the 1st generation of OTC products will be related to their rx products in any way.

It will probably be products like this: https://www.dnaegfrenewal.com/collections/a...eneration-serum also high end sunscreens will of course fit. The sunscreens found in most stores are surprisingly crappy with some pretty bad chemicals in them too.

Skin damage prevention (or "sun burn prevention") will likely be pursued after Vitiligo. No reason why it wouldn't be. It doesn't need a lotion. It can use the implant. I personally would prefer the implant than a daily lotion (I hate things on my skin). High risk populations like skin type 1 would benefit from it and if it was reasonably cost an insurance company may pay for it because cancers are expensive. Though, it could be an rx product that people pay for out of pocket (look at botox. That is rx, administered by a medical facility, and people generally pay for it out of pocket).

I think Clinuvel will of course have a topical that creates a tan, but it won't be OTC within the next few years. There are various rules on OTC products in the US. About whether drugs can penetrate the skin and how much is allowed, what active ingredients, etc.


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Justinian
post Posted: Oct 16 2019, 02:26 AM
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In Reply To: CUV88's post @ Oct 16 2019, 01:53 AM

I’m pretty sure you’re right. The new molecules for topicals could be OTC but would still have to go through the normal 3 phase trials. I highly doubt the OTC product being released soon induces melanogenesis, I bet it’s something else.

 

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seeva222
post Posted: Oct 16 2019, 02:06 AM
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In Reply To: FarmaZutical's post @ Oct 15 2019, 04:17 PM

I definitely picked up on the theme of photo protection for the entire population.

 
CUV88
post Posted: Oct 16 2019, 01:53 AM
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In Reply To: Kboy69's post @ Oct 16 2019, 01:12 AM

Me too. But mela-hormone in OTC? Im quite sure thats not possible without trials.



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CLINUVEL's SCENESSE Potential: 1.)EPP 2.)Vitiligo 3.)SUN Protection and skin cancer prevention
 
Kalaz
post Posted: Oct 16 2019, 01:53 AM
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In Reply To: FarmaZutical's post @ Oct 15 2019, 04:17 PM

Farma, I was thinking the same thing 😎

 
Kboy69
post Posted: Oct 16 2019, 01:12 AM
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In Reply To: seeva222's post @ Oct 15 2019, 11:41 PM

Call me crazy, but I'm more excited about the OTC products, mainly because they possibly benefit me more. I'm waiting for my 'tan in a tube'...

 
 


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