Endo Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its new prescription medicine Aveed (testosterone undecanoate) injection to treat adult men with hypogonadism (commonly known as Low-T) that is linked 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 3mL (750mg) intramuscular injection given once at initiation of therapy, at four weeks, and then every ten weeks afterwards.
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The approval is based on data from an 84-week Phase III trial of hypogonadal men in the US.
Patients participated in the trial had an average age of 54 years and a serum total testosterone level of less than 300ng/dL.
Endo president and chief executive officer Rajiv De Silva said: "Aveed expands our branded portfolio of men’s health products and highlights our passion and commitment to providing high-quality therapies that improve patient care.
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"With Aveed, Endo can now offer men living with hypogonadism different treatment options to raise testosterone levels.
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By GlobalData"We are focused on getting Aveed to market to ensure that appropriate patients have access to it."
In the Phase III trial, Aveed increased mean serum testosterone levels, maintaining them for up to ten weeks at steady state.
The company said that Aveed is approved with a risk evaluation and mitigation system (REMS) requiring prescriber education and certification, as well as restricted product distribution.
Miriam Hospital co-director of the Men’s Health Center and Alpert Medical School clinical associate professor of family medicine and urology Martin Miner said 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," Miner said.
"As with any prescription therapy, hypogonadal men should talk to their doctor about the potential risks and benefits of testosterone replacement therapy so they can make an informed treatment decision."
Aveed injection is indicated for replacement therapy in adult males for conditions related with a deficiency or absence of endogenous testosterone, including primary hypogonadism and hypogonadotropic hypogonadism.
It has a boxed warning for serious pulmonary oil microembolism (POME) reactions and anaphylaxis, and 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).
