هيئة الغذاء والدواء تعتمد “تيستيستيرون” يوضع تحت الابط

في سابقه هي الأولى من نوعها أعتمدت هيئة الغذاء و الدواء الأمريكيه عقار أكسيرون لشركة ليلي الأمريكيه , و هو أول عقار تستيستيرون يوضع تحت الابط

FDA Approves First Underarm Testosterone Replacement Therapy

The US Food and Drug Administration (FDA) has approved testosterone 2% topical solution (Axiron; Eli Lilly and Co and Acrux) as the first testosterone replacement therapy to be applied to the underarm, in much the same way as deodorant.

The action was based on data from a phase 3 multicenter, open-label, 120-day clinical trial (n = 155), showing that 84.1% of men with hypogonadism achieved testosterone blood levels within the normal range (mean, 504 ng/dL; normal range, 300 to 1050 ng/dL), often within a 2-week period. Results also showed that treatment significantly improved mood, sexual desire, sexual activity, and sexual performance.

“The posttreatment changes demonstrated positive responses in sexual desire, sexual activity, mood, and general well-being, underpinning the patient-reported benefits of this treatment. Patient compliance and acceptance of the unique no-touch axilla application technique was very good,” said lead investigator Christina Wang, MD, from the Los Angeles Biomedical Research Institute and professor of medicine at UCLA David Geffen School of Medicine, California, in a company news release.

Testosterone topical solution is a Schedule III controlled substance supplied in a metered-dose pump with a no-touch applicator. The recommended initial dose is 1 pump actuation (30 mg) applied to each armpit once daily at the same time each morning; previous use of underarm deodorants or antiperspirant does not alter efficacy, nor are there any grooming requirements such as shaving. However, to avoid contamination of the deodorant or antiperspirant, application before the testosterone solution is recommended.

Dosing can be 30 mg (1 actuation), 60 mg (2 pump actuations), or 90 mg (3 actuations), depending on serum testosterone concentrations obtained from a blood draw 2 to 8 hours after application and at least 14 days after initiation of therapy.

As with other topical testosterone preparations, the product’s safety labeling includes a boxed warning regarding the potential for virilization in children with secondary exposure to treated skin. Because of the risk for fetal harm, women who are pregnant or who might become pregnant should avoid contact with the application site.

Patients should be instructed to wash their hands with soap and water immediately after applying the testosterone solution, and to cover the application site with clothing after the solution has dried. The treated area should then be kept covered until washed. There should be no swimming or washing of the underarm area for 2 hours after application.

Adverse events reported in more than 4% of clinical trial patients include increased hematocrit, headache, diarrhea, vomiting, and serum prostate-specific antigen. In a study extension (n = 52) designed to monitor skin safety over 6 months of continuous use, 8 patients reported some form of transient application-site reaction during the initial 4-month treatment phase; all cases were of mild to moderate intensity and resolved quickly without intervention.

Patients with benign prostatic hyperplasia should be monitored for worsening of associated signs and symptoms. All patients should be evaluated for prostate cancer at baseline, 3 to 6 months after initiation of therapy, and then in accordance with screening practices.

Because polycythemia can require dose reductions or discontinuation of therapy, hematocrit should be obtained at baseline, 3 to 6 months after initiation of therapy, and annually thereafter.

Testosterone therapy can decrease blood glucose levels, potentially altering insulin requirements in diabetic patients. For those on anticoagulant therapy, testosterone can cause changes in activity, necessitating more frequent monitoring of international normalized ratio and prothrombin time on initiation and discontinuation of therapy. Concomitant use of corticosteroids can increase fluid retention and should be monitored cautiously, particularly in patients with cardiac, renal, or hepatic disease.

Previously approved forms of testosterone replacement therapy include oral and buccal tablets, subcutaneous pellets, transdermal patches, injections, and manually applied topical gels.