Shots:
- The approval is based on a P-III clinical trial that involves assessing Solosec (2g, PO, granules) vs PBO in 64 patients with trichomoniasis
- The P-III trial demonstrated 92.2% cure rate in the modified ITT population and 94.9% in the per-protocol population, therapy was well-tolerated with no serious AEs were identified in the trial
- Additionally, the study demonstrated that ~70% of women with trichomoniasis are PCR positive for BV. Solosec (secnidazole) is the first single-dose oral prescription approved to treat both trichomoniasis & BV in the US
Click here to read full press release/ article | Ref: Lupin | Image: PR Newswire
The post Lupin’s Solosec (secnidazole) Receives the US FDA’s Approval for the Treatment of Trichomoniasis first appeared on PharmaShots.
