Pharmaceutical

FDA approves first-ever nasal testosterone spray

Natesto logo FDA approves first ever nasal testosterone sprayThe Food and Drug Administration (FDA) has given clearance for the first-ever nasal testosterone replacement treatment.

Natesto Nasal Gel, manufactured by Trimel Pharmaceuticals, is intended for adult males with conditions associated with deficiency or absence of endogenous testosterone, including primary hypogonadism or hypogondotropic hypogondism. Low testosterone levels are associated with symptoms such as low libido, muscle loss, fatigue and weight gain.

Natesto is self-administered into the nostrils via a metered-dose pump applicator, which delivers 5.5 mg of testosterone. The recommended dosage is 11 mg, or two pumps (one in each nostril), three times daily. The nasal spray offers a new alternative to testosterone gels, which can easily be transferred unintentionally to others – including women and children – which can result in adverse effects.

Natesto will enter a rapidly growing market of testosterone supplements, which include the commonly prescribed brands Testim and AndroGel. The new testosterone treatment was approved amid a flurry of controversy over the safety of testosterone products, which recent studies have shown increase the risk of heart attacks, strokes, and death from any cause in older men.

Natesto was approved based on clinical studies that showed the product’s effectiveness in older men. Adverse effects were noted in thee percent or more of participants and included an increase in prostate-specific antigen, headache, rhinorrhea, epistaxis, nasal discomfort, nasopharyngitis, bronchitis, upper respitatory-tract infection, sinusitis, and nasal scab. Some experts questioned whether the nasal spray would increase brain testosterone levels too much, as indicated in animal studies. They advise physicians to “proceed with caution” with Natesto.

Source: MedScape