Table 1. Consensus Target Product Profile (TPP) developed by the gonorrhea expert group.
| Short-term (up to 5 years) | Long-term (up to 10 years) | |||
|---|---|---|---|---|
| Ideal | Acceptable | Ideal | Acceptable | |
| Indication | (First-line) treatment of uncomplicated, urogenital gonorrhea (susceptible and MDR) | (First-line) treatment of uncomplicated, urogenital gonorrhea (susceptible and MDR) | (First-line) treatment of urogenital gonorrhea (susceptible and MDR, complicated and uncomplicated) | (First-line) treatment of urogenital gonorrhea (susceptible and MDR) |
| First-line treatment of extra-genital gonorrhea (ano-rectal and oro-pharyngeal) | First-line treatment of extra-genital gonorrhea (ano-rectal and oro-pharyngeal) | |||
| Treatment of Chlamydia infections | ||||
| Activity against coinfecting STI pathogens | Chlamydia trachomatis | Chlamydia trachomatis, Mycoplasma genitalium | Chlamydia trachomatis | |
| Patient population | Adults and adolescents (aged 10–19 years) | Adults, children, and adolescents | ||
| Clinical efficacy | 97% (95% CI, 95–100) | 95% (95% CI, 90–100) | 97% (95% CI, 95–100) | 95% (95% CI, 90–100) |
| Activity against ESC and macrolide-resistant NG strains | Yes | Yes | ||
| Mechanism of action (target site, -cidal versus static; broad-spectrum versus narrow-spectrum) | Bactericidal/static | Bactericidal/static | Unique mechanism | |
| Intracellular activity | – | Bactericidal/static | Bactericidal/static | |
| No cross-resistance | Limited cross-resistance | Intracellular activity | – | |
| No cross-resistance | Limited cross-resistance | |||
| Safety and tolerability | Well tolerated in pregnancy and lactation | – | Well tolerated in pregnancy and lactation | – |
| No patient monitoring required post treatment | Minimal outpatient monitoring required post treatment | No patient monitoring required post treatment | Minimal outpatient monitoring required post treatment | |
| Contra-indications | None | Pregnancy and lactation | None | Pregnancy and lactation |
| Drug–Drug Interaction profile | None | Minimal | None | Minimal |
| Route of Administration/formulation | Oral/IM, separated combination | Fixed-dose combination for orals | Copackaged loose combination | |
| Dosing Schedule | Single dose | Multiple doses | Single dose | Multiple doses |
| Treatment duration | 1 day | Up to 5 days | Up to 3 days | Up to 5 days |
| Stability | Heat stable, 3-year shelf-life in climatic region IVa | Heat stable, 3-year shelf-life | Heat stable, 3-year shelf-life in climatic region IV | Heat stable, 3-year shelf-life |
| Cost (price/day of therapy) | Equivalent to current treatment regimens | Equivalent to current treatment regimens | ||
| Time to patient availability | 5 years | 7 years | 7 years | 10 years |
ESC, extended-spectrum cephalosporin; IM, intramuscular injection; IV, intravenous injection; MDR, multidrug-resistant; NG, Neisseria gonorrhoeae; STI, sexually transmitted infection.
aHot tropic/humid climate, simulated with 30°C and 65% relative humidity.