FDA approves Endo’s Aveed injection for hypogonadism treatment

Hypogonadism (commonly known as Low-T) is related with a deficiency or absence of the male hormone testosterone.

The medicine 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.

Endo president and chief executive officer Rajiv De Silva said Aveed expands the company’s branded portfolio of men’s health products and highlights its passion and commitment to providing high quality therapies that improve patient care.

"With AVEED, Endo can now offer men living with hypogonadism different treatment options to raise testosterone levels," De Silva said.

"We are focused on getting AVEED to market to ensure that appropriate patients have access to it."

The approval is based on data secured from an 84-week Phase III trial of hypogonadal men in the US.

Adults participated in the trial had an average age of 54 years and a serum total testosterone level of less than 300ng/dL.

In the Phase III trial, Aveed increased mean serum testosterone levels, maintaining them for up to 10 weeks at steady state.

Aveed injection is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, including primary hypogonadism and hypogonadotropic hypogonadism.