Endo Pharmaceuticals, a global specialty healthcare company, has received FDA approval of AVEED (testosterone undecanoate) injection for the treatment of adult men with hypogonadism (commonly known as Low-T) that is associated with a deficiency or absence of the male hormone testosterone. AVEED is a new prescription medicine indicated to produce serum testosterone levels in the normal range by administration of a single 3-mL (750mg) intramuscular injection given once at initiation of therapy, at four weeks, and then every 10 weeks thereafter. It is expected to be available in early March.
The approval of AVEED is based on data from an 84-week phase III trial of hypogonadal men in the U.S. Men enrolled in the study had an average age of 54 years and a serum total testosterone level of less than 300ng/dL. In the phase III study, AVEED increased mean serum testosterone levels, maintaining them for up to 10 weeks at steady state (between weeks 14-24).AVEED is approved with a Risk Evaluation and Mitigation System (REMS) requiring prescriber education and certification as well as restricted product distribution.
"Physicians have prescribed FDA-approved testosterone replacement therapies for many years to help treat men diagnosed with testosterone deficiency, or hypogonadism. AVEED is an important new option that may be suitable for some men given its dosing schedule and administration," said Martin Miner, M.D., co-director of the Men's Health Center at Miriam Hospital and a clinical associate professor of Family Medicine and Urology at Brown University's Warren Alpert School of Medicine, Providence.
AVEED 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). AVEED has a Boxed Warning for serious pulmonary oil microembolism (POME) reactions and anaphylaxis. It should be used in patients who require therapy and in whom the benefits of the product outweigh the serious risks of POME and severe allergic reaction (anaphylaxis).