Benzinga | Jan 13, 2022 11:46AM EST

Endo Announces Publication Of New AVEED Data In Peer-Reviewed Journal Of Clinical Pharmacology; Data Evaluates Dosing Flexibility In Men With Hypogonadism

Endo International plc (NASDAQ:ENDP) announced today the publication of data from a population pharmacokinetic (PK) modeling and simulation study, evaluating potential dosing flexibility of AVEED(r) (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(r) 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.1

The findings from this PK model and simulation were published in The Journal of Clinical Pharmacology. See online version of the article.

AVEED(r) 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(r) 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.

Male hypogonadism, an impairment of testosterone production or other physiological activity of the gonads, can be due to a primary testicular disorder (primary hypogonadism) or secondary to dysfunction of the hypothalamic-pituitary-testicular axis (hypogonadotropic hypogonadism).2 The normal range of serum testosterone level is between 300 ng/dL and 1,000 ng/dL. Safety and efficacy of AVEED(r) in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established. Safety and efficacy of AVEED(r) in males less than 18 years old have not been established.1

While the majority of hypogonadal men treated with AVEED(r) maintain normal serum testosterone levels for the full 10 weeks with the currently approved regimen, there is a small portion of patients who experience a decrease in testosterone levels prior to the next dose. The modeling data indicate that for those patients who experience a trough testosterone level below 300 ng/dL while on treatment, a different dosing regimen with shortened injection interval may help them maintain serum testosterone levels within the normal range between dosing. Further clinical prospective study will be needed to assess the clinical relevance of these predictions.