FDA Approves Aveed Testosterone Undecanoate Product

The FDA has long been known as a slow moving organization.  And when it comes to testosterone nothing could be more true.  The best example of this is seen with testosterone undecanoate.  A long acting form of testosterone which requires less frequent injections than current FDA approved drugs such as testosterone cypionate, and testosterone enanthate, which both require at least bi-weekly injections.

Until recently testosterone undecanoate was not approved for use in the United States.  However testosterone undecanoate has been approved for use as testosterone replacement therapy (TRT) in Europe as early as 2003 [1].   Finally, a few days ago the FDA approved Endo Pharmaceuticals testosterone undecanoate formulation called Aveed.  Aveed testosterone is a 250 mg/mL based oil that is prescribed to hypogonadal males.  The recommended use is 3mL injections (750 mg’s) to initiate TRT, then another injection at week 4, and injections ongoing every 10 weeks thereafter.  So over the initial 14 weeks, Aveed testosterone only needs injected 3 times, vs. testosterone cypionate which would need as many as 7 injections over the same time frame for TRT.

In the below image you can see the average testosterone levels of over 100 men when they were administered Aveed testosterone [2].  This particular graph shows levels from week 14 on.  As you can see testosterone levels tend to range from normal high to normal low over the 10 week period between injections.

Aveed testosterone

Now for some of you who prefer their testosterone levels a supra-physiological levels, this isn’t particularly exciting or anything new.  Still for many men on TRT this is quite simply a more convenient form of testosterone administration.  It allows for very infrequent injections (that your doctors office can probably do for you), and you don’t have to mess with transdermal gels formulations of testosterone.  Transdermal’s also come with contact risk, which is why I tend to tell people to avoid transdermal prohormones if they have kids, pets, and significant others of the opposite sex [4].

Even with the strict prescribing guidelines set by the FDA, I suspect this will eventually become the preferred choice of TRT prescribing physicians and TRT patients alike.

By Travis DeGraff


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