The FDA has given final approval for Vogelxo, a topical testosterone gel used for the treatment of hypogonadism.
Vogelxo was previously studied in a randomized, multicenter, placebo-controlled 90-day trial that included 406 adult men with testosterone levels of 300 ng/dL or less. After measuring for sufficient data, the researchers found that in 192 hypogonadal men, 74% of them achieved normal serum testosterone levels within 90 days.
The recommended starting dose of Vogelxo is 50 mg applied topically each day on the shoulders and upper arms. Dosage may be adjusted depending on patient needs.
Developed by Upsher-Smith Laboratories of Maple Grove, Minn., the drug will be marketed in the near future.