Sulfadoxine-pyrimethamine

Sulfadoxine-pyrimethamine

Product development
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Regulatory review
Swipha/Biogaran
Chemoprevention
Bioequivalence
Intermittent preventative treatment (TPP-1)
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), 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
  • 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