The FDA has approved Aveed (testosterone undecanoate injection; Endo Pharmaceuticals) for the treatment of hypogonadism in adult men. Aveed is indicated as a testosterone replacement therapy for conditions associated with a deficiency or absence of endogenous testosterone, including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired) in adult males.
The approval was based on data from a Phase 3 trial of hypogonadal men over 84 weeks. The average patient age was 54 years with a serum total testosterone level of less than 300ng/dL. Aveed was shown to increase mean serum testosterone levels, while maintaining them for up to 10 weeks at a stable level (between weeks 14–24).
Aveed is only available through the restricted Aveed Risk Evaluation and Mitigation Strategy (REMS) Program. Expected availability is in early March.
For more information call (484) 216-7158 or visit Endo.com.