Testosterone Nasal Gel Product Gets Delayed by the FDA

[Excel Male]

CompleoTRT, which was submitted to the FDA earlier last year, is Trimel's most advanced product candidate, and is a bio-adhesive intra-nasal gel formulation of testosterone, designed to provide hypogonadal patients with a better alternative to current treatment options. Male hypogonadism is a condition in which the body doesn't produce enough testosterone — the hormone that plays a key role in masculine growth and development during puberty — or has an impaired ability to produce sperm or both.
Last month, Trimel said that following recent discussions with the FDA, it decided that the most expeditious way to seek approval of its treatment was to proceed with a proposed three-times-a-day dosing protocol, requiring a change to its proposed label to exclusively reflect this dosing regimen.
At the time the decision was announced, on December 19, Rossi said: "The company continues to believe that a twice-per-day dose represents a promising alternative for patients with hypogonadism and we are considering options for pursuing approval for such a dosing regimen."

http://www.proactiveinvestors.com/c...s-target-date-for-testosterone-nda-51354.html

 

[GettingAnswers]

Three times a day is a deal killer IMO. I don't see how that is better than once a day topical or once or twice a week for injections. Can't imagine dosing compliance would be good at all.

 

[Vettester Chris]

We can't seem to get Nebido therapy in this country, not sure how they will get this one by.

 

[Nelson Vergel]

I have been following the Nebido (Aveed in the US- ingredient: Testosterone undecanoate) story since day one. I hope they get to approve it this year. It will change a lot of things in the testosterone replacement market in the United States. Unfortunately, I am sure the price will be over 500 dollars per shot of 1000 mg. The FDA will not allow the 1000 mg dose to be given all at once like it is done is all countries. More on Nebido here

This nasal CompleoTRT has no future. Who will dose twice or three times a day in 2014?

 

[Vettester Chris]

Thanks, Nelson! This place is loaded with good information

 

[MFool]

I was in the trial so I speak from absolutely first hand experience. I can see the 3 x being an issue. It was not for me. I carry a lot of junk in my pocket and didn't have an issue with compliance. The product worked, it was my first experience with TRT, sex drive came back, brain fog went away, quite extrordinary.

I hope they get this out. I can see why they were trying for two x /day. I was one of the 3x per day and I can see the issue with a lot of men. (Hey as I said I use Afrin at times what's another thing in my pocket.

Questions ask me, but remember my experience IS first hand. I used the product.