Canada’s Trimel Pharmaceuticals Corp has been given the green light in the USA for its low testosterone therapy and presented positive mid-stage data on its product for female orgasmic disorder.
First up, the US Food and Drug Administration has approved Natesto, making it the first testosterone nasal gel for replacement therapy in adult males for hypogonadism associated with a deficiency. The product is self-administered via a nasal applicator, reducing the risk of secondary exposure to testosterone of women or children.
Trimel said it is conservatively estimated that nearly 13 million American men may have low testosterone levels and current treatments include topical gels, subcutaneous pellets, transdermal patches, intramuscular injections and tablets. Natesto, chief executive Tom Rossi noted, comes with “this novel route of administration [which] will enable men to take this therapy in mere seconds, without worrying about the risk associated with transferring the product to women or children”.
As the FDA green light came through, Trimel had unveiled Phase II for Tefina, another nasal testosterone gel, in development for FOD (also known as anorgasmia) which is characterised by a delay, absence or reduced intensity of orgasm, causing clinically significant distress.
The study enrolled 253 pre- and post-menopausal women experiencing acquired FOD who were randomised to one of three dosage strengths (0.6 mg, 1.2 mg, 1.8 mg) or placebo. The first dose led to a statistically significant increase in the average number of orgasms during the 84-day treatment period of 2.3 versus 1.7 for the placebo arm.
Improvements in all of the secondary endpoints, included change in sexual functioning and sexual event satisfaction, were observed, but Trimel noted that further analysis is underway to assess statistical significance. Tefina was well-tolerated with no reported serious adverse events.
