Trimel soars on FDA approval for nasal gel to treat testosterone-deficient men
Trimel Pharmaceuticals (TSE:TRL) surged on Thursday after news that it has received U.S. FDA approval for its Natesto testosterone nasal gel, extending gains from the previous session.
Shares rose to as high as 92 cents during the morning hours, lately up at 89 cents, an increase of more than 25%. This week, the company's stock has risen more than 50%, buoyed by news on Wednesday that it received encouraging results from a phase II clinical trial of Tefina, a testosterone nasal gel designed to treat female orgasmic disorder.
The Natesto gel, for which it has received U.S. regulatory approval today, is the first and only testosterone nasal gel for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, according to the company's statement.
The drug is self administered via a nasal applicator, minimizing the risk of secondary exposure to women and children.
"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," said president and CEO Tom Rossi.
"We are now focused on getting Natesto to market as expeditiously as possible so that appropriate patients can have access to it."
According to a company release, it is estimated that nearly 13 American men may have low testosterone levels, with current treatment options including topical gels, transdermal patches, intramuscular injections and oral tablets.
"In my practice I regularly encounter men demonstrating symptoms of hypogonadism and physicians will increasingly see this as the North American population ages," said the medical director and founder of Clinical Research of South Florida, Dr. Jeffrey Rosen.
"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."