Sulfadoxine-pyrimethamine

Emzor Pharmaceutical
Bioequivalence
Chemoprevention
Intermittent preventative treatment (TPP-1)

Sulfadoxine-pyrimethamine

Product development
-
Regulatory review
Product vision
  • Intermittent preventive treatment during pregnancy (IPTp)
Dosing
  • 3 tablets of 500 mg sulfadoxine - 25 mg pyrimethamine, to be given monthly at the beginning of the 2nd trimester of pregnancy until delivery
Efficacy
  • WHO affirmed the effectiveness of IPTp using SP (IPTp-SP), including in areas with SP resistance
  • Full course of IPTp-SP estimated to decrease the incidence of low birthweight babies by 29%, severe maternal anaemia by 38%, and neonatal mortality by 31%. It is also one of the few health interventions showing reductions in neonatal mortality
Key features
  • Adapted SP packaging to ensure correct use and to improve perception and uptake
Challenges
  • Delivery of IPTp requires a functioning antenatal care platform and access to quality-assured SP
  • Improving quality perceptions about SP and expanding access through community health worker channels can increase IPTp coverage
Status
  • Dossier submitted to WHO for pre-qualification (Incl Date)
Next milestone
  • Development of dispersible 250 mg sulphadoxine-12.5 mg pyrimethamine for intermittent preventive treatment for infants (IPTi)
Project Director
  • Pierre Hugo