Fiocruz – also known as Farmanguinhos - was named as a new member by the Pediatric Praziquantel (PZQ) Consortium last week, which explained that the Brazilian state-owned drugmaker will make a pediatric formulation of the medication praziquantel for clinical trials.
Elly Kourany-Lefoll, who leads the schistosomiasis pediatric formulation project, told in-Pharmatechnologist.com that: “Fiocruz will produce the racemate PZQ finished product investigational trial material… for clinical trials to be conducted in Brazil and Africa.”
Kourany-Lefoll explained that at present no pediatric version of PZQ is available and suggested that complex formulation challenges combined with strict regulations on medicines for children had hampered development.
“A pediatric formulation of PZQ is not easy to develop technically using available taste masking technologies as the PZQ drug substance is very bitter. In addition, the drug must meet the applicable ICH and WHO guidelines for pediatric development, has to be affordable and adequate to use in very young children in tropical settings.
“One of the other reasons why developers have not developed this presentation until now may be the need for clinical trials in the targeted children population.”
The Consortium is trying to address this need in collaboration with formulation specialists and researchers at Astellas Pharma, Merck KGaA, Swiss TPH, Top Institute Pharma, Simcyp and now Fiocruz.
According to Kourany-Lefoll: “The manufacture of the racemate PZQ finished product formulation phase I investigational trial material is funded by Farmanguinhos with raw materials financed by a grant that Merck received from the Bill & Melinda Gates Foundation.”
“We expect the new formulation to be launched in the first countries in 2019. Fiocruz will produce the drug for local supply in Brazil and may also procure the drug to neighboring endemic countries in Latin America and Sub-Saharan Africa.
She added that: “The consortium is also assessing local manufacturing of the commercial pediatric drug.”