FDA Approves Nasal Testosterone Amid Safety Investigation

FDA Approves Nasal Testosterone Amid Safety InvestigationMay 30, 2014 — The U.S. Food and Drug Administration (FDA) has approved Natesto, an inhalable form of testosterone that is manufactured by Trimel Pharmaceuticals.

Natesto is used to treat hypogonadism (low testosterone). The nasal spray is taken in two spritzes three times a day. Two sprays contain about 5.5-mg of testosterone, and the daily dose is 33-mg. The most common side effects were prostate specific antigen (PSA), headache, and nasal problems.

Men with hypogonadism now have a wide range of testosterone replacement products to choose from — topical gels, patches, subcutaneous pellets, injections, underarm liquid, and even a buccal tablet absorbed through the gums. Currently, the most popular product is AndroGel, manufactured by AbbVie. The advantages of Natesto over AndroGel is that there is a much lower risk of transferring testosterone to women and children through skin-to-skin contact.

Approval was based on a 90-day Phase III trial of 306 men with hypogonadism who were an average of 54 years old. At the end of the study, 90% of men on Natesto had testosterone levels in the normal range.

Testosterone replacement therapy has grown rapidly in popularity over the last few years, but studies of the long-term health effects are lacking. Recently, the FDA has launched a safety investigation into several studies linking testosterone and heart attacks, stroke, and death — especially among older men.

Most topical testosterone gels are associated with an increased risk of blood clots in the legs. This is because testosterone often increases the amount of red blood cells produced by the bone marrow. In people with narrow arteries or other risk-factors, this “thickening” of the blood could potentially increase their risk of a cardiovascular event.

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