Trimel Pharmaceuticals has announced that an 84-day Phase 2 trial of its Tefina testosterone nasal gel for the treatment of anorgasmia in women found that the lowest of three doses tested produced a statistically significant increase in the number of orgasms experienced compared to placebo. The study involved more than 250 women in the US, Canada, and Australia.
According to the company all of the secondary endpoints showed improvement and no serious adverse events were reported.
Trimel President and CEO Tom Rossi commented, “These results mark an important milestone in the development of Tefina. They provide further evidence that Tefina could represent an important treatment option for the many women who suffer from this disorder. On behalf of Trimel and its various stakeholders, I am extremely excited about this positive outcome and look forward to advancing this product towards commercialization.”
Completion of a previous Phase 2 study for this indication was announced in October, 2011. The company is also developing a nasal gel formulation of testosterone for hypogonadism and submitted an NDA for that product in April 2013.
Trimel also owns the TriVair dry powder inhalation platform for both pulmonary and intranasal delivery.
Read the Trimel press release.
