New Pediatric Formulation and Expanded Uses Granted for Antimalarial Drug, Pyramax

December 23, 2015

Lawrence Fleckenstein, professor emeritus in the Division of Pharmaceutics and Translational Therapeutics at the UI College of Pharmacy, has spent years working with a team from around the world on an antimalarial drug called Pyramax. The Pyramax team recently received notification of approval of a new pediatric granule formulation and expanded uses for the drug. Specifically, the European Medicines Agency (EMA) approved changes to formulations of the drug for treating children down to 5 kg (approximately 11 pounds). In addition, the EMA approved important changes to the label for the adult tablet formulation.  

Pyramax was first approved by the EMA in 2012 for use in a film-coated tablet to treat malaria caused by P. falciparum and P. vivax in adults and children over 20 kg (approximately 44 pounds). The Committee for Medicinal Products for Human Use (CHMP) has recommended to add a new pharmaceutical form, granules for oral suspension, and as a result, the use of Pyramax in this formulation will be extended to children and infants weighing 5 kg to less than 20 kg. The CHMP also recommended an extension of the indication for Pyramax to remove restrictions on repeated courses of treatment in patients and on its use only in areas of low malaria transmission with evidence of artemisinin resistance.

Pyramax, an antimalarial combination of pyronaridine/artesunate for the treatment of acute malaria, is a joint project between Medicines for Malaria Venture (a nonprofit organization based in Switzerland), Larry Fleckenstein’s laboratory at the University of Iowa College of Pharmacy, and Shin Poong Pharmaceuticals in South Korea. Fleckenstein formerly served as the chair of the product development team for Pyramax and primarily contributes to the pharmacokinetic aspects of the project, including work for the approval of the new formulation.

To read more, please visit the EMA’s website.