FDA Approves the First-Ever Nasal Testosterone Treatment Natesto

Natesto is the first-ever testosterone replacement therapy administered via intranasal….

The FDA approved Natesto for adult males with conditions associated with deficiency or absence of endogenous testosterone, which include: primary congenital or acquired hypogonadism, or congenital or acquired hypogonadotropic hypogonadism.

Natesto is administered via a metered-dose pump activator into the nostrils. In a one-pump actuation 5.5 mg of testosterone is delivered. The recommended dose is 11 mg, which equals 2 pump actuations accounting as one in each nostril, 3 times daily, for a total of 33 mg per day.

A phase III, multicenter, open-label trial of 306 hypogonadal men at 39 US clinical research sites was conducted to evaluate Natesto. The study involved patients ages 28 to 80 with a mean age of 54 years old. The patients were 89% white (271), 6% African American (18), 5% of an Asian decent (16), and less than 1% were recorded as “other”. During the Natesto treatment period, which lasted 90 days, patients were instructed to administer Natesto intranasally. Seventy-eight patients were treated with 33 mg of testosterone daily. Out of the 78 patients 73 were included in the statistical evaluation of the efficacy on day 90. Ninety percent of the patients had average serum testosterone concentrations over 24 hours within the normal range (300-1050 ng/dL). However, the other 10% of patients that had an average serum testosterone concentration over 24 hours was below 300 ng/dL, and 0% of patients had average serum testosterone concentrations over 24 hours above 1050 ng/dL.

According to the clinical trial, about 3% or more subjects experienced adverse reactions such as, an increase in prostate-specific antigen, a headache, rhinorrhea, epistaxis, nasal discomfort, nasopharyngitis, bronchitis, upper-respiratory-tract infection, sinusitis, and/or nasal scab.

The brain’s testosterone levels will be much higher with intranasal testosterone gel administration than with other routes, Brandley D. Anawalt, MD, chief of medicine at the University of Washington Medical Center in Seattle, and chair of the Hormone Health Network for the Endocrine Society, pointed out. In 2009, a study was published to show brain levels of testosterone that were about twice as high in mice that received intranasal testosterone gel than in mice receiving intravenous testosterone. Dr. Anawalt advices physicians to “proceed with caution.”

• Natesto is the first-ever testosterone replacement therapy administered via intranasal.
• Natesto was approved for adult males with conditions associated with deficiency or absence of endogenous testosterone
• Natesto is administered via a metered-dose pump activator into the nostrils. In a one-pump actuation 5.5 mg of testosterone is delivered. Recommended dose is 11 mg.

Press Release: https://trimelpharmaceuticals.com/News/ID/117/Trimel-Receives-FDA-Approval-for-Natesto-Nasal-Gel-to-Treat-Men-with-Low-Testosterone