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Natesto (Nasal Testosterone) Approved Amid FDA Safety Study


May 30, 2014 — Trimel Pharmaceuticals has received approval for Natesto, the first-ever nasal testosterone spray for the treatment of hypogonadism (low testosterone).

Natesto is administered with two spritzes three times per day. Each spritz contains 5.5-mg of testosterone, bringing the total daily dose to 33-mg. The most common side effects included nasal irritation, scabs, runny nose, upper respiratory tract infection, and more.

The FDA approved Natesto after a 90-day Phase III clinical trial involving 306 men with hypogonadism found that 90% of men on Natesto had normal testosterone levels by the end of the study.

Testosterone replacement therapy has never been more popular. The approval of Natesto comes at a time when men have a wide variety of options — topical gel, underarm liquid, injections, subcutaneous pellets, patches, and even an oral buccal tablet. The advantages of Natesto over topical testosterone gels like AndroGel is that skin-to-skin contact is less likely to spread testosterone to women and children.

Despite a growing number of testosterone treatment options, researchers still do not fully understand the long-term risks and benefits. This is concerning, because testosterone therapy is a lifetime commitment. The body stops producing its own (albeit low) levels of testosterone in response to supplemental drugs.

In January, the FDA opened a safety investigation into possible cardiovascular risks of testosterone therapy. Testosterone can elevate the number of red blood cells, “thicken” the blood, and elevate blood pressure. Several recent studies have raised concern that this could lead to a deadly heart attack or stroke, especially among older men.


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