FDA's May 28 approval of Natesto, the first nasally delivered testosterone gel for hypogonadism, came just in time for Canada's Trimel Pharmaceuticals, which had just $18 million left on hand at the beginning of the year.
"Men suffering from 'Low T' will now have a different option to raise their testosterone levels. This novel route of administration will enable men to take this therapy in mere seconds, without worrying about the risk associated with transferring the product to women or children. We are now focused on getting Natesto to market as expeditiously as possible so that appropriate patients can have access to it," CEO Tom Rossi said in a statement.
Testosterone treatments remain in potentially treacherous heart health territory, however. A Journal of the American Medical Association study found that using testosterone increased the risk of death from heart attack or stroke by 29% in men with or without a history of heart disease.
The FDA has taken notice. It blocked approval of Endo's ($ENDP) testosterone therapy, Aveed, three times due to the risks of castor oil, a part of the formulation that has been linked to blood-vessel blockages in the lungs and other postinjection complications.
In March, the agency finally approved Aveed as an injection given once to begin therapy, once four weeks later, and every 10 weeks after that. Meanwhile, Clarus Therapeutics has submitted an orally delivered therapy for low testosterone to the FDA and should receive approval (or rejection) by November.
Although Natesto carries a warning for "edema with or without congestive heart failure" in patients with preexisting conditions, it could still save Trimel, and by extension its novel delivery mechanism, which could have other applications besides the now $1.5 billion-plus market for Low T treatments (due in part to heavy advertising).
Around the time of the approval, the company revealed that one of three doses of its experimental nasal testosterone gel Tefina significantly increased the average number of orgasms during an 84-day period for the women in the drug arm to 2.3, compared to 1.7 in the placebo arm. Several biotechs have tried to crack the female sexual dysfunction treatment market, but none have succeeded.
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