Shots:
- The US FDA has approved Nuzolvence for the treatment of uncomplicated urogenital gonorrhea in pts (age ≥12yrs.; Wt.≥35 kg), with US commercialization planned for the H2’26
- Approval was based on a pivotal P-III multinational trial (n=930) evaluating a single 3g oral dose of Nuzolvence vs ceftriaxone (500 mg IM) + azithromycin (1 g oral) for uncomplicated urogenital gonorrhea, which demonstrated non-inferiority, comparable tolerability with no serious adverse events, and was conducted across 16 sites in five high-prevalence countries
- Nuzolvence (single-dose oral) is a spiropyrimidinetrione antibiotic targeting bacterial type II topoisomerase, developed through a not-for-profit collaboration with GARDP, which sponsored and led the P-III trial supporting FDA approval
Ref: Innoviva Specialty Therapeutics | Image: Innoviva Specialty Therapeutics |Press Release
Related News: LIB Therapeutics Receives the FDA Approval for Lerochol (Lerodalcibep-liga) for Adults with Elevated LDL Cholesterol
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
