FDA Approval of Nebido not promising

[Millard]

The approval of the U.S. version of the long-acting testosterone undecanoate injection is not looking promising. AVEED is known as NEBIDO in the rest of the world.

http://phx.corporate-ir.net/phoenix.zhtml?c=123046&p=irol-newsArticle_print&ID=1361674&highlight (Endo Phamaceuticals Inc. - Investor Relations News Release)=

The FDA is concerned about "post-injection anaphylactic reaction" and "pulmonary oil microembolism".

Why would this ester be more problematic than other testosterone esters? Injection volume (4ml) probably has a lot to do with it.

Bayer Schering Nebido

 

[Bill Roberts]

That does seem the best guess.

Too bad to lose out on hundreds of millions in sales due to not knowing that 4 mL at a time in a single injection site is not a good idea.

 

[Davevanza]

NEBIDO under brand name of REANDRON 1000mg ( Testosterone Undecanoate) is available in Australia.

It is considered as the safest, and usually the first choice treatment for an HRT.

It has a stable constant level in the blood for up to 3 months, and does not fluctuate down, unlike Sustanon or Primoteston Depot.

Yes, it comes ina 4mls amp, but the slow administration of gluteal injection using 23gauge needle by a GP does not pose any problem at all.

I tried it for a year, and the effect is more amazing than Sustanon 250mg.

I have no idea of why the FDA in the States still puts that into consideration.

 

[Bill Roberts]

Slow injection by a GP?

In the US, the doctors believe the plunger is competing in a drag race.

 

[Millard]

NEBIDO under brand name of REANDRON 1000mg ( Testosterone Undecanoate) is available in Australia.

It is considered as the safest, and usually the first choice treatment for an HRT. [...]

I have no idea of why the FDA in the States still puts that into consideration.

It has been approved in 86 countries worldwide including most of Europe. I am surprised at this FDA roadblock.

Maybe Solvay didn't want competition for Androgel?

 

[dfein]

They approved the oral form though right?

 

[Jeton]

Slow injection by a GP?

In the US, the doctors believe the plunger is competing in a drag race.

i know this too well.

 

[bigrobbie]

Slow injection by a GP?

In the US, the doctors believe the plunger is competing in a drag race.

[)][)] TRUE!!

 

[Millard]

They approved the oral form though right?

Not in the U.S. I think it's in Phase II?

 

[cvictorg]

The approval of the U.S. version of the long-acting testosterone undecanoate injection is not looking promising. AVEED is known as NEBIDO in the rest of the world.

http://phx.corporate-ir.net/phoenix.zhtml?c=123046&p=irol-newsArticle_print&ID=1361674&highlight (Endo Phamaceuticals Inc. - Investor Relations News Release)=

The FDA is concerned about "post-injection anaphylactic reaction" and "pulmonary oil microembolism".

Why would this ester be more problematic than other testosterone esters? Injection volume (4ml) probably has a lot to do with it.

Bayer Schering Nebido

Indevus Pharmaceuticals: Nebido Has Lost Its Libido -- Seeking Alpha

Why did the FDA significantly protract Nebidos approval review date? It comes down to a few isolated cases of transient reversible shortness of breath and coughing following an injection.

In the U.S. clinical trials, which included a total of approximately 500 patients, there was a single instance of this phenomenon with the 750 mg (3ml) dosage of Nebido. The patient did not require medical intervention and the event resolved within 10 minutes. In Germany, there were some reports of the same phenomenon with the larger volume (4ml) 1000 mg dosage of Nebido.

Mind you, these were not results from German clinical trials. Instead, they are from post-marketing adverse reports that occurred (rarely) in Germany. The most serious side effects were even rarer: flushing, dizziness and fainting. There were no permanent injuries reported.

Most importantly, these adverse reactions were most likely not due to any pharmaceutical shortcomings inherent in the drug itself. Instead, they appear to be a result of improper injection of the drug itself resulting in venous absorption of the drug.