FDA Approved Natesto Nasal Gel to Treat Men with Low Testosterone

[Nelson Vergel]

Trimel Pharmaceuticals Corporation announced today (May 28.2014) that the United States Food and Drug Administration (FDA) has approved Natesto (testosterone), formerly CompleoTRT, the first and only testosterone nasal gel for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Natesto is self-administered via a nasal applicator thereby minimizing the risk of secondary exposure to testosterone of women or children.

The product is self-administered into the nostrils via a metered-dose pump applicator. One pump actuation delivers 5.5 mg of testosterone, and the recommended dose is 11 mg (2 pump actuations, 1 in each nostril), 3 times daily (total 33 mg/day).

Bradley D. Anawalt, MD, chief of medicine at the University of Washington Medical Center, Seattle, and chair of the Hormone Health Network for the Endocrine Society, pointed to a theoretic concern, that brain testosterone levels will be much higher with intranasal testosterone gel than with other testosterone treatments. A study published in 2009 using mice showed brain levels of testosterone that were about twice as high in mice who received intranasal testosterone gel than in mice receiving intravenous testosterone. "What this finding means and whether it applies to men is unknown," he told Medscape Medical News.

 

[Nelson Vergel]

More information about all other available testosterone replacement treatment options: https://www.excelmale.com/forum/showthread.php?1487-Testosterone-Replacement-Treatment-Options

 

[Eric Peterson]

I think that the 3x/day dosing could be a deal breaker. I would also like to see what tolerability was in the study as well as in real-life populations. There are a number of intranasal medications that have been poorly tolerated and therefore never caught on. Intranasal calicitonin comes to mind.

 

[Nelson Vergel]

Eric

You are right. I wonder why anyone would spend the money to develop this option? It will have the same fate as Striant . http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ac47efbe-025b-4688-bcd3-a10a0b012b34

 

[Dr. John Crisler]

I would not have heard of this product yet were I not a member here.

 

[MFool]

Direct Experience with Trimel's intranasal T gel

I was a participant in the actual study for this product. (one of the last six month ones in Rochester NY) For a comparison the product was my first experience with TRT. Prior to that I used nothing and had symptoms. Three days into first use in hindsight I realized just how bad my testosterone symptoms were. Brain fog, ED, tiredness all vanished. I have chronic allergies so to be blunt shoving something up my nose wasn't a big deal to me.

Now after I got thrown out of the study (I had a UTI go figure) due to some of my blood levels going wonky (again that UTI) I went on Gel. Gel worked for about a year getting me to 450-550 (in the 300 to 1100 scale). My E2 went up from the 20 it was at back to 80 or so (from the gel) my ankles swelled up again and my gyno reacted. After a year on Gel I am struggling with Testim (having been switched from my doctor off AG) 2 tubes / day and still trying to get up to 450. i.e. Gel sucks so my alternatives now become all the usual other options of shots, pellets.

So I'd go back to the intranasal with no hesitation. My levels were stable, I felt terrific. My sex life was reasonable.. (uh my wife isn't taking hormones LOL) orgasms were better blah blah blah.

So will 3 x /day be a deal breaker. It wasn't for me. I have the experience of the intranasal as my first experience and finding out first hand the inherent problems of TD.

I'll be curious about the cost. (duh)
How likely those wonderful bean counters at Aetna are to make the product hard to get.
How the price (there again) compares to AG, Testim and Testopel (shots as we all know are in a different cost universe)

If you're motivated you really can get used to anything. I carry more crap around in my pockets jackets, etc. Frankly at times if I missed a mid day dose I either skipped it or made it up later.

So we'll see, but I have first hand experience in the Trimel intranasal product and it's a safe bet that most of you reading this do not. (oh and my T levels were 750 generally which for me was frigging awesome.

 

[SuperDutyDave]

Intersting product. 3X per day does seem excessive but if it easy to handle (no refrigeration) and absorbtion and resulting levels are sufficent then maybe.......

Still going to require HCG so not like needles are going away Curious if E conversion will be less?

Last question would be cost......comparable to T-Cyp? Or more like androgel?

 

[Nelson Vergel]

SuperDutyDave

It will take a few months for the product to be available in pharmacies. We do not pricing yet.

I am definitely not using anything that requires 3 times per day dosing. I know I will forget the middle dose.

 

[SuperDutyDave]

Nelson. Yes three times seems like a pain. I might consider it if it would eliminate the needle thing but with the necessity of HCG and B-12 needles aren't going so not much advantage.

 

[MFool]

Nelson yep, on the 3x that will eliminate some. Cost I'd be pleasantly shocked if it was close to injectible.... I'd say it's going to be more in the cost range of the other TD's, that would be my guess. I did find I hadn't gotten my levels up with anything close to what I got with the intranasal. Gels are not cutting it, and I was being driven to either pellets, or (sigh) injections. Neither are pleasant to contemplate. As I've said, I'm using to shoving nose spray up my nose so yet another substance when I was in the study didn't bother me.

In terms of E2, mine was better on the intranasal then on TD. I'm on an AI now and didn't use one during the study. I tend towards high E2 as my swollen feet LOL attested to. But cost... my guess is the obnoxious rates that Androgel and Testim now charge. This is a "what the market will bear" costing.

 

[MFool]

Boy is this product slow to get to market. I'm still waiting and wondering what the heck it will cost.

 

[Nelson Vergel]

Mfool...wow, 6 months! That is a long time for sure.

 

[MFool]

LOL, yep stuff certainly takes a long time.

 

[Nelson Vergel]

Starting my trial today.

 

[CoastWatcher]

Looking forward to your reports.

 

[MFool]

A year... wow that's a slow to market. So Nelson how is it going so far. I shudder to think how much crap I'll have to go through with Aetna depending on what schedule they throw this on. (especially since some T gels are now generic)

 

[Nelson Vergel]

Good things:

- It seems to work quickly
- Probable placebo effect: I have had two great workouts and feel hornier.

Bad things:

- I get face flushed and a feeling of "pressure" in my head
- My blood pressure goes up for 20 min or so after administration
- I have more sinus congestion than usual.
- 3 times per day makes adherence difficult.

 

[Tom Larabee]

Nelson:

Good things look good.

Not liking the bad things, especially since I have enough issues with seasonal allergies, I wouldn't want to add this to it.

 

[MFool]

Natesto, the Nelson Vergel test

Good things:

- It seems to work quickly
- Probable placebo effect: I have had two great workouts and feel hornier.

Bad things:

- I get face flushed and a feeling of "pressure" in my head
- My blood pressure goes up for 20 min or so after administration
- I have more sinus congestion than usual.
- 3 times per day makes adherence difficult.

Nelson when I took it in Rochester I was not on TRT at all. I had no expectations so I'd question at least in my case if there was any placebo effect. I had no clue what TRT would do. A week into it (remember no TRT at all and my initial levels were 270) my brain fog lifted and I was actually horny. (from nothing oy vey that was an accomplishment)

Congestion wasn't an issue for me. I have allergies too and when I wasn't congested the administration was not an issue. When I was congested I used Afrin a half hour or so before. Did I absorb as well with Afrin.. heck probably not but better then nothing.

My blood pressure didn't budge. Yes I have for months seen the point of the 3 x per day. I'm sure it will be a deal breaker for some. The initial testing was two different groups one was 2 x a day and mine was 3 x /day. I guess the 3 x per day numbers were overall better.

I suspect the deal killer for me will be the f*cking insurance carrier. I am still quite curious how much we'll be screwed over for the cost of this. It is (as I've claimed) I'm sure going to be just as expensive as the other name brands. Just the "what the market will bear".

My E2 was less with the intranasal then it is now with the gel. (yes I use an AI and yes I'm aware of too low being just as crappy as too high)

It will be interesting to see how your test goes.

 

[CoastWatcher]

Nelson, How long before you do a blood draw? How many half-life cycles are you giving it?