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FDA approves nasal testosterone therapy
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The first testosterone nasal gel for replacement therapy in adult men has been approved by the FDA for use in conditions associated with a deficiency or absence of endogenous testosterone, according to the manufacturer.
Natesto (testosterone, Trimel Pharmaceuticals Corporation) — an androgen intended to treat patients with primary or hypogonadotropic hypogonadism, congenital or acquired — is self-administered via a nasal applicator, minimizing the risks of secondary exposure to testosterone by women or children, according to the release.
The alternate delivery system is alone among an array of exogenous preparations that focus on restoring physiological testosterone including topical gels, subcutaneous pellets, transdermal patches, intramuscular injections, oral tablets and a buccal patch.
Available as a metered-dose pump, one pump delivers 5.5 mg of testosterone. The recommended dose is 11 mg — one pump per nostril — applied three times daily, for a total of 33 mg each day.
The safety and efficacy of Natesto in men younger than 18 years are not established at this time, according to the release. The drug is contraindicated in men with breast cancer or known or suspected prostate cancer, and not recommended for use in patient with chronic nasal conditions.
The approval of Natesto follows a multicenter, open-label, 90-day phase 3 trial that looked at men with hypogonadism at clinical research centers across the United States. Of the 73 men included in the statistical evaluation of treatment efficacy, 90% had were within normal range.
For more information: Trimel Receives FDA Approval for Natesto Nasal Gel to Treat Men with Low Testosterone