Endo International plc's operating company Endo Pharmaceuticals Inc. received US Food and Drug Administration (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 (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.

"Today's FDA approval of Aveed is a significant milestone for Endo.  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," said Rajiv De Silva, president and chief executive officer of Endo.  "With Aveed, Endo can now offer men living with hypogonadism different treatment options to raise testosterone levels.  We are focused on getting Aveed to market to ensure that appropriate patients have access to it."

The approval of Aveed is based on data from an 84-week Phase 3 trial of hypogonadal men in the US.  Men enrolled in the study had an average age of 54 years and a serum total testosterone level of less than 300 ng/dL.  In the phase 3 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.  "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."

"Men's Health Network is pleased to see the FDA approval of a new treatment for hypogonadism as we believe men with this condition should have access to a broad range of treatment options," said Ana Fadich, MPH, vice president of the national non-profit organization Men's Health Network.  "Men diagnosed with hypogonadism and their partners need to have an open discussion, with each other and the man's doctor, about the condition and ways to manage it so they can find the right treatment that best suits their individual needs."

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).

Aveed is available as a single-use vial.  Dosage titration is not necessary.  Following the first intramuscular injection of 3 mL of Aveed (750 mg), a second 3 mL dose is injected 4 weeks later, and then 3 mL is injected every 10 weeks thereafter.  Aveed is prescribed and administered by trained healthcare providers in a doctor's office, clinic, or hospital.

Aveed contains testosterone undecanoate, which Endo licensed through its subsidiary Endo Pharmaceuticals Solutions Inc. from Bayer Pharma AG.  Outside the US, Bayer Pharma AG and its subsidiaries have been marketing testosterone undecanoate injections since 2003.

Endo International plc is a global specialty healthcare company focused on improving patients' lives while creating shareholder value.

Endo Pharmaceuticals Inc., headquartered in Malvern, PA, is focused on developing and delivering high-value branded pharmaceutical products that meet the unmet needs of patients.