According to Trimel Pharmaceuticals, the FDA has approved its Natesto nasal testosterone for men with low levels of endogenous testosterone. Trimel submitted an NDA for the product, then called CompleoTRT, in April 2013.
Trimel President and CEO Tom Rossi said, “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. 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.”
News of the approval came shortly after the company announced positive Phase 2 results for its Tefina nasal testosterone for the treatment of anorgasmia in women.
Read the Trimel press release.
