Phase IV study of Natesto shows benefits in hypogonadism maintained.- Acerus Pharma

Acerus Pharmaceuticals Corporation announced data from the phase IV Natesto (intranasal testosterone gel) Spermatogenesis Study which demonstrated that 95% of men treated with Natesto for hypogonadism for three and six months, maintained their semen parameters within the normal range while increasing serum testosterone levels to normal and improving hypogonadal symptoms. This is the first such study to demonstrate conclusively that a testosterone replacement therapy (TRT) can maintain key fertility parameters in hypogonadal men. Researchers attributed these findings to Natesto's fast absorption and unique dosing schedule designed to produce fluctuations of testosterone levels in the bloodstream. In total, 55 men were eligible and enrolled in the trial. Of the 55 who enrolled, 33 patients have completed the six-month treatment period. Nearly all subjects completing the six-month treatment period had their testosterone levels return to the normal range. Mean (SD) serum testosterone levels increased from 230 (62) ng/dL at baseline to 605 (278) ng/dL at six months (p=0.005).

In addition, mean baseline levels of Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) (3.9 IU/mL and 4.0 IU/mL, respectively) were preserved within the normal range over this time (2.6 IU/mL and 3.0 IU/mL, respectively). Most importantly, mean semen parameters remained unchanged (P > 0.05):Additionally, there was improvement across all domains of erectile function including libido and overall sexual satisfaction, as well as improvement in overall energy, which are common hypogonadal symptoms. No serious adverse events (AEs) were reported in the study. The most commons AEs were nasal irritation (five cases, 13.1%), oligospermia (three cases, 7.9%) and azoospermia (one case, 2.6%). All of these men recovered spermatogenesis after discontinuation. Data were presented as part of the "Late Breaking" Abstract Session at the 75th Annual American Society for Reproductive Medicine (ASRM) Scientific Conference in Philadelphia, PA.

Comment: Natesto is a nasal gel formulation of testosterone developed by Acerus Pharmaceutical Corporation and indicated as a replacement therapy for men diagnosed with conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). It is the first and only nasally-administered testosterone product approved by the U.S. Food and Drug Administration, Health Canada and South Korea Ministry of Food and Drug Safety (MFDS), available in a 'no-touch' dispenser with a metered dose pump.