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FDA Approves Injectable Testosterone Replacement Therapy, Aveed (Testosterone Undecanoate)

Product launch scheduled for March

The FDA has approved Aveed (testosterone undecanoate, Endo Pharmaceuticals) injection for the treatment of adult men with hypogonadism that is associated with a deficiency or absence of the male hormone testosterone.

Aveed is indicated to produce serum testosterone levels in the normal range by administration of a single 3-mL (750-mg) intramuscular injection given once at initiation of therapy, at 4 weeks, and then every 10 weeks thereafter. It is expected to be available in early March.

The FDA's approval was based on data from a pivotal 84-week phase III trial of Aveed in hypogonadal men in the U.S. The study participants had an average age of 54 years and a serum total testosterone level of less than 300 ng/dL. Treatment with Aveed increased mean serum testosterone levels, maintaining them for up to 10 weeks at steady state (between weeks 14 and 24).

Aveed (testosterone undecanoate) injection is an androgen indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). The drug has a boxed warning for serious pulmonary oil microembolism (POME) reactions and anaphylaxis. It should be used for patients in whom the benefits of the product outweigh the serious risks of POME and anaphylaxis.

Aveed is available as a single-use vial. Dosage titration is not necessary. The drug has been approved with a risk evaluation and mitigation strategy (REMS) requiring prescriber education and certification as well as restricted product distribution.

In 2009, the FDA issued a complete response letter stating that Aveed could not be approved because of the agency’s concern about the risk of POME and anaphylaxis occurring immediately after injection.

The product’s developer (Endo) submitted another new drug application (NDA) that presented additional information from a review of clinical and postmarketing databases to identify and characterize all cases of POME and anaphylaxis associated with Aveed.

According to the FDA briefing document compiled by Endo, Aveed provides hypogonadal men with a new testosterone-replacement formulation that achieves normal testosterone levels in most patients (94% of subjects in the pivotal phase III trial). Other therapeutic benefits of treatment include the following:

  • Intramuscular injection does not carry the risk of transference, which may endanger children and women who inadvertently come into contact with men taking topical testosterone gel products.
  • Aveed does not exceed supraphysiological testosterone levels like the short-acting injectables.
  • The drug does not require a surgical procedure like pellets and does not result in gum irritation like a buccal preparation.

Further, based on independently adjudicated results from the clinical database, POME occurs at a rate of 1.5 (95% confidence interval [CI], 0–3.2) cases per 10,000 injections. Similarly, based on independently adjudicated results from the clinical database, anaphylaxis occurs at a rate of 0 (95% CI, 0–10.4) cases per 10,000 patients treated.

Sources: Endo; March 6, 2014; and FDA; April 18, 2013.

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