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

  | Ref: Lupin | Image: PR Newswire