FDA Approved Natesto Nasal Gel to Treat Men with Low Testosterone

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CoastWatcher

Moderator
The prescribing information for Natesto offers specific ranges that should be used when evaluating the drug's efficacy.


When the total testosterone concentration consistently exceeds 1050 ng/dL, therapy with Natesto should be discontinued. If the total testosterone concentration is consistently below 300 ng/dL, an alternative treatment should be considered.


When I used Androgel, I don't recall such directives regarding blood levels being part of the prescribing inserts/online resources for patients and doctors.
 
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Nelson Vergel

Founder, ExcelMale.com
CoastWatcher

That is a stupid statement. I cannot believe the company would say to discontinue instead of reduce the dosing frequency. But I guess the fact that the product has a short half life, a twice per day instead of three times per day dosing frequency may not sustain blood levels evenly through the day. Also, there is no way to decrease the amount pumped into the nostrils.

The minimum concentration reached between dosing averaged only 215 ng/dL (not great at all), but the peaks approach 1000 ng/dL. Quite a wide fluctuation in one day!

www.accessdata.fda.gov drugsatfda_docs label 2014 205488s000lbl.pdf.png

natesto blood levels.png
 
Last edited:

CoastWatcher

Moderator
CoastWatcher

That is a stupid statement. I cannot believe the company would say to discontinue instead of reduce the dosing frequency. But I guess the fact that the product has a short half life, a twice per day instead of three times per day dosing frequency may not sustain blood levels evenly through the day. Also, there is no way to decrease the amount pumped into the nostrils.

The minimum concentration reached between dosing averaged only 215 ng/dL (not great at all), but the peaks approach 1000 ng/dL. Quite a wide fluctuation in one day!


It seemed odd to me, as well. The entire tone of the text was a bit detached. The fluctuations could raise interesting questions in regard to blood draws, couldn't they?
 

CoastWatcher

Moderator
It reminds me of Andriol, Merck's oral test undecanoate, available here in Canada. I'm told by two or three pharmacists that there was a flurry of prescribing when it initially hit the shelves, but doctors soon learned that patients didn't like the twice-daily regimen - to say nothing of its failure to achieve consistently reasonable levels.
 

Nelson Vergel

Founder, ExcelMale.com
I stopped using it after 3 days because of the three times per day dosing (I forgot the second dose twice), I got very stuffy nose and gave me a small head ache 15 min after applying it.

I would not switch from injections or gels to this product. However, it may be a good option to use right before the gym or sex for a quick T boost. I did get a little hornier on it and used that mild "rush" well at the gym.
 

madman

Super Moderator

I have been reading up on this quite a bit Nelson.

Even though it needs to be dosed 2-3 times/day there are good peaks (short term) and varibility throughout the day with good levels.

A few co-workers of mine are on Natesto.

AYTU Bioscience owns the rights to Natesto and they have it manufactured here in Canada by Acerus Pharmaceuticals Corporation located in Mississauga, Ontario not too far from where I live.

Not sure if you are into the stock market as I never was but recently purchased a nice chunk of shares from AYTU as they are really cheap right now and even though it is only a penny stock company which over the last few years started trading on the NASDAQ I feel it may be a gold mine in the long term as they have many other products down the pipeline for men/womens sexual health.

Hope the management/marketing team can end up doing well and eventually gain a share of the trt market as it seems like an effective product along with a good safety profile which can benefit many men with low t.

I am thinking if things go well.....long shot 2020 is when this company may take off!
 
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