FDA: First Nasal Spray Approved to Treat Hypogonadism

The FDA has approved the first testosterone nasal gel for the treatment of patients with hypogonadism.

Natesto—previously known as CompleoTRT—is a self-administered nasal spray taken in 2 doses (5.5 mg of testosterone each) 3 times daily. 

In a phase III trial, researchers followed 73 men (mean age of 54) with hypogonadism treated with total 33 mg of Natesto daily. 
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Of the 73 men, 90% had testosterone levels in the normal range (300 ng/dL to 1050 ng/dL) by the end of the study.

Natesto is not to be used in men with suspected prostate cancer. The most common side effects included an increase in prostate specific antigen, headache, rhinorrhea, epistaxis, nasal discomfort, bronchitis, upper respiratory infection, and sinus and nasal scabs.

–Michael Potts

Reference

Trimel Pharmaceuticals. Trimel receives FDA approval for Natesto nasal gel to treat men with low testosterone [press release]. May 28, 2014. http://trimelpharmaceuticals.com/News/ID/117/Trimel-Receives-FDA-Approval-for-Natesto-Nasal-Gel-to-Treat-Men-with-Low-Testosterone. Accessed June 17, 2014.