Acerus (formerly Trimel) has announced that it will pursue development of its Tefina nasal testosterone for the treatment of hypoactive sexual desire disorder (HSDD) instead of for female orgasmic disorder (FOD). In May 2014, the company announced positive results from a Phase 2 study of Tefina for FOD.
The decision to switch course came after meeting with the FDA and determining that “it is apparent that Acerus could face several regulatory challenges on the path to FOD approval in the US.” Given the recent approval of Addyi flibanserin for HSDD, the company said, that indication seems like a better bet.
Acerus President and CEO Tom Rossi said, “While we continue to believe that Tefina may provide a benefit to women suffering from FOD, the recent FDA approval of flibanserin in HSDD marks a significant development which cannot be overlooked. The regulatory path to approval in HSDD is now established, and the increased patient and physician awareness surrounding the disorder is expected to drastically improve study recruitment and implementation. By shifting our focus to developing a treatment for HSDD, our hope is to be able to offer a convenient, non-invasive, ‘on-demand’ option to the many women experiencing this medical condition.”
Acerus’s Natesto intranasal testosterone was approved by the FDA for the treatment of men with low levels of endogenous testosterone in May 2014, and Endo acquired US and Mexican rights to that product in November 2014. According to Acerus, Endo has now de-prioritized Natesto as part of a “portfolio optimization process” and Acerus is delaying any further studies “until the implications of this portfolio optimization process are fully known.”
Read the Acerus press release.
