TORONTO — Trimel Pharmaceuticals on Wednesday announced that the Food and Drug Administration has approved Natesto (testosterone), formerly CompleoTRT, the first and only testosterone nasal gel for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
Natesto is self-administered via a nasal applicator, thereby minimizing the risk of secondary exposure to testosterone of women or children.
"In my practice, I regularly encounter men demonstrating symptoms of hypogonadism and physicians will increasingly see this as the North American population ages," said Jeffrey Rosen, the medical director and founder of Clinical Research of South Florida. "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."
According to Trimel, it conservatively is estimated that nearly 13 million American men may have low testosterone levels. Current treatment guidelines focus on the restoration of the physiological testosterone level through the use of exogenous testosterone preparations, which include topical gels applied by the hands, subcutaneous pellets, transdermal patches, intramuscular injections and oral tablets, as well as a buccal patch.
"The FDA approval for Natesto is a major achievement for our company, as it validates our clinical research and development efforts, as well as reinforces our commitment to provide innovative treatment options for patients," said Tom Rossi, Trimel Pharmaceuticals president and CEO. "Men suffering from 'Low T' will now have a different option to raise their testosterone levels. 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."