Natesto, formerly CompleoTRT, is self-administered via a nasal applicator thereby reducing the risk of secondary exposure to testosterone of women or children.
Clinical Research of South Florida (CRSA) medical director and founder Jeffrey Rosen said in his practice he regularly encounters men showing symptoms of hypogonadism and physicians will increasingly see this as the North American population ages.
"For these patients seeking to restore their testosterone levels, Natesto will offer an alternative delivery system that is safer and more convenient than the other options currently available on the market," Rosen said.
In the US, about 13 million men are expected to have low testosterone levels.
Trimel Pharmaceuticals president and CEO Tom Rossi said the FDA approval for Natesto is a major achievement for the company, as it validates its clinical research and development efforts, as well as reinforces its commitment to provide new treatment options for patients.
"Men suffering from ‘Low T’ will now have a different option to raise their testosterone levels." Rossi said.
"This novel route of administration will enable men to take this therapy in mere seconds, without worrying about the risk associated with transferring the product to women or children.
"We are now focused on getting Natesto to market as expeditiously as possible so that appropriate patients can have access to it."
Low testosterone also called as male hypogonadism is a condition in which the testicles, hypothalamus or pituitary gland is affected by disease or damage that results in inhibiting hormone and testosterone secretion.