Primaquine dispersible

B&O Pharm
Transmission reduction
Paediatric formulation
Bioequivalence
Prevention of relapse for P. vivax (TPP-1)

Primaquine dispersible

Product development
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Patient confirmatory
Product vision
  • Product targeting prevention of relapse for P. vivax
  • Product for transmission reduction
Dosing
  • 2.5 mg and 5 mg tablets, 14-day course in all transmission settings to prevent relapse, treat P. vivax or P. ovale malaria in children and adults 
  • A single dose of 0.25 mg/kg primaquine with ACT to patients with P. falciparum malaria (except pregnant women, infants aged <6 months and women breastfeeding infants aged < 6 months) to reduce the transmissibility of treated P. falciparum infections in low-transmission settings
Efficacy
  • WHO guidelines recommend primaquine to prevent relapse, treat P. vivax or P. ovale malaria in children and adults (except populations mentioned above), unless they are known not to be G6PD deficient.
Key features
  • Would be first child friendly dispersible formulation
Challenges
  • Limited use in low-transmission settings
Status
  • Prototype developed and tech transfer undertaken
  • Bioequivalence study protocol WHO Ethics Review Committee (ECR) approved 

  • Scaling up the formulation and manufacturing pilot-scale batches for bioequivalence study
Next milestone
  • Bioequivalence study start in Q1 2023
Project Director
  • Pierre Hugo