FDA approves another testosterone replacement gel

June 9, 2014

The FDA has approved a new testosterone gel formulation, marking the agency’s second approval of a testosterone replacement therapy in the course of a week.

The FDA has approved a new testosterone gel formulation, marking the agency’s second approval of a testosterone replacement therapy in the course of a week.

On June 4, a topical testosterone gel to be marketed under the brand name Vogelxo was approved. A week earlier, as previously reported, the FDA approved a testosterone nasal gel known as Natesto.

Both agents are indicated for the treatment of adult males with hypogonadism. Their approvals come at a time when the FDA is investigating testosterone agents for a possible increased risk of cardiac events.

In a randomized, placebo-controlled study of Vogelxo, of 192 hypogonadal men (those with morning testosterone ≤300 ng/dL) who were appropriately titrated with the testosterone gel and who had sufficient data for analysis, 74% achieved an average serum testosterone level within the normal range (300 to 1,000 ng/dL) after 3 months of treatment, according to the drug’s package insert.

The gel is applied to the shoulders and/or upper arms. Upsher-Smith Laboratories, Inc., the drug’s maker, said in a press release that it is preparing to launch Vogelxo in “the near future.”

The FDA investigation of low T agents was announced in January following the publication of two studies (PLOS ONE [published online Jan. 29, 2014] and JAMA 2013; 310:1829-36), both of which reported an increased risk of cardiac events, including heart attack and stroke, associated with testosterone therapy. The studies have drawn widespread criticism, and a group known as the Androgen Study Group has called for retraction of the JAMA article, citing “gross data mismanagement.”

More on testosterone/hypogonadism

TRT shows benefit, no harm in post-RP patients

Study: Testosterone linked to progressive weight loss

Estradiol boosts libido in men receiving testosterone

 

 

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