Sulfadoxine-pyrimethamine

Swipha/Biogaran
Chemoprevention
Bioequivalence
Intermittent preventative treatment (TPP-1)

Sulfadoxine-pyrimethamine

Product development
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Regulatory review
Product vision
  • Intermittent preventive treatment during pregnancy (IPTp)

  • Intermittent preventive treatment of infants (IPTi)
Dosing
  • 3 tablets of 500 mg sulfadoxine - 25 mg pyrimethamine (SP; dosed via three tablets), to be given 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

  • A 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%.
Key features
  • One of the few health interventions showing reductions in neonatal mortality
  • 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

  • Bioequivalence study completed in 2020

  • Dossier submitted to WHO Prequalification 
Next milestone
  • WHO prequalification

  • Development of dispersible 250 mg sulphadoxine-12.5 mg pyrimethamine for intermittent preventive treatment for infants (IPTi)
Project Director
  • Pierre Hugo