The West African Network for Clinical Trials of Antimalarial Drugs (WANECAM) phase IIIb/IV led by Prof. Abdoulaye Djimde, University of Science, Techniques and Technologies of Bamako, Mali, evaluated the safety and effectiveness of antimalarials over a 2 year period. Pyramax® and Eurartesim® (dihydroartemisinin-piperaquine) were compared with ACTs used for standard treatment in the region (artemether-lumefantrine and artesunate-amodiaquine). Patients were treated with the same antimalarial each time they had a malaria episode.
A sub-study analysis of the patients treated with Pyramax® revealed that the medicine was as well tolerated and efficacious on retreatment as on first administration. These findings recently published in The Lancet Infectious Diseases were used to support the label variation for Pyramax® and a positive scientific opinion of a new child friendly formulation of the ACT, Pyramax® Granules.
In its press release MMV states: “In parallel with the introduction of Pyramax Granules in endemic countries, MMV and Shin Poong will work with partners to conduct a Phase IV pharmacovigilance study to generate further data about Pyramax tablets and Pyramax Granules in real-life settings”.