Positive Phase III Data for secnidazole (Solosec) in females with trichomoniasis

The Phase 3 placebo-controlled RCT met its primary endpoint of microbiological cure, defined as a negative trichomonas vaginalis culture, in the modified intent-to-treat (92.2% vs 1.5%; p<0.001) and per-protocol populations (94.9% vs 1.7%; p<0.001) with no serious adverse events.

SPS commentary:

Based on this data, a supplemental New Drug Application will be submitted to the FDA for the treatment of trichomoniasis. UK and EU developmental status is currently unknown.


Biospace Inc.