FDA Clears First Nasal Testosterone Therapy

The FDA has approved the first nasal testosterone replacement therapy for use in men suffering from conditions associated with a deficiency or absence of endogenous testosterone.

The product, Natesto, is self-administered via a nasal applicator, thus minimizing the risk of exposing women and children to testosterone. One pump actuation delivers 5.5 mg of testosterone. The recommended dose of Natesto is 11 mg of testosterone (2 pump actuations, one per nostril), applied intranasally three times daily for a total daily dose of 33 mg.

The preparation is contraindicated in men with breast cancer or known or suspected prostate cancer.

In a press release, the drug's maker, Trimel Pharmaceuticals Corp., of Toronto, said patients with benign prostatic hyperplasia should be monitored for worsening signs and symptoms.

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