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.
Source:
Biospace Inc.
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.