Testosterone: Back to the Drawing Board!

It's all in the spin.  Is the glass half-full or half-empty.  From Endo Pharmaceutical's press release issued 2 days ago, you could discover that the Food and Drug Administration had just issued a complete response letter to their New Drug Application for AVEED, an injection form of testosterone undecanoate.  In this complete response letter, the FDA did not ask for more clinical data but rather clarified issues necessary for approval of the NDA, specifically updating its requirement for Risk Evaluation and Mitigation Strategy to include Medication Guide as well as Elements to Assure Safe Use.

As I was reading this from Endo's perspective, I thought, wow, the FDA is finally going to crack down on performance enhancing drug use.  In fact, it turns out the FDA is actually concerned about rare but  severe post-injection reactions, especially pulmonary microembolism and anaphylaxis from its use of castor oil during formulation or its use of benzyl benzoate as an excipient.  This should come as no surprise given the FDA's Advisory Committee concerns a month earlier.

But if you ask the editorial staff of MedPageToday, this is akin to the FDA shooting down yet another attempt by Endo to legalize use of this long acting testosterone here in the States.  You have to admire Endo's tenacity.  After all, they've been trying repeatedly to bring testosterone undecanoate to the market since August 2007.  But lest you be concerned about this form of testosterone, rest assured that Bayer's Nebido brand of testosterone undecanoate has been approved for use since 2004 outside of the States.

So if you live in the States, your options are "limited" to Androderm, Androgel, Axiron, Fortesta, Testim, Striant as well as injectable Testosterone Cypionate & Enanthate and implantable pellets, all under your physician's supervision.  Personally, I'd stay away from oral Android, Methitest, Oxandrin, Testred & Virilon due to their greater hepatic toxicity compared to non-oral forms.  There you have it.  While we not have access to Testosterone Undecanoate here, we do have many other options.  Looks like the glass is both half empty and half full!

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