Endo International plc announced the publication of data from a population pharmacokinetic (PK) modeling and simulation study, evaluating potential dosing flexibility of AVEED® (testosterone undecanoate) in hypogonadal males. The objective of this population PK analysis was to assess the potential impact of a more frequent dose regimen of testosterone undecanoate (8 weeks vs. 10 weeks) on exposure parameters of clinical interest.

The current FDA-approved recommended dose of AVEED® is 3 mL (750 mg) injected intermuscularly, followed by 3 mL (750 mg) injected after 4 weeks, then 3 mL (750 mg) injected every 10 weeks thereafter. The findings from this PK model and simulation were published in The Journal of Clinical Pharmacology. See online version of the article.

AVEED® is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.

Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone "releasing hormone (LHRH) deficiency or pituitary "hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. AVEED® should only be used in patients who require testosterone replacement therapy and in whom the benefits of the product outweigh the serious risks of pulmonary oil microembolism and anaphylaxis.