MMV Project of the Year award - 2008
Every 30 seconds a child dies from malaria. Coartem Dispersible was developed to address the specific treatment needs of millions of children worldwide suffering from this life-threatening disease.
Coartem Dispersible, now approved by Swissmedic and prequalified by WHO, is a sweetened, quick-dispersing formulation that eases administration and promotes effective malaria treatment. Results of studies are encouraging, with a recent study in The Lancet showing that Coartem Dispersible provided the same high efficacy rates and tolerability as Coartem® tablets.
In January 2009, Novartis and MMV launched Coartem Dispersible, a new paediatric formulation of Coartem (artemether/ lumefantrine 20 mg/ 120 mg ), for the treatment of uncomplicated falciparum malaria in infants and children. This exciting new formulation took four years to develop. The clinical programme, conducted jointly by Novartis and MMV, consisted of three studies :
- A palatability study conducted in healthy African children to test prototypes of three flavours. The cherry flavour was accepted by children and chosen for further development as it masked the bitter taste of Coartem the best.
- A study in healthy volunteers carried out to establish the relative bioavailability of Coartem Dispersible tablets compared to crushed Coartem tablets (the latter being the current way in which the medicine is administered to children). The pharmacokinetics and bioavailability of artemether, dihydroartemisinin, and lumefantrine where also all shown to be similar.
- A randomized, investigator-blinded, multi-centre, parallel-group Phase III study to compare efficacy, safety and tolerability of Coartem Dispersible tablets with Coartem crushed tablets in the treatment of acute uncomplicated falciparum malaria in infants and children. A total of 899 children were included. The study has recently been published in The Lancet and demonstrated that Coartem Dispersible tablets provides a high cure rate of 97.8 %, comparable to that of Coartem tablets (98.5 %). Investigators also reported that Coartem Dispersible had a good safety profile. Dr Salim Abdulla, the study’s lead investigator confirmed that the study showed that a three-day regimen of Coartem Dispersible provides children with high cure rates. So, young patients, who are often the ones at greatest risk, can get a sweet and easy to administer medicine that offers the same efficacy as experienced by people taking regular Coartem.
Coartem Dispersible contains the same amounts of artemether and lumefantrine as the existing commercial form of Coartem, the leading ACT in Africa, and is the first dispersible fixed-dose ACT developed specifically for children, to ICH standards.
Drugs currently used to treat malaria are very bitter and often need to be crushed before children can swallow them; this can weaken the effect of the medicine. The new, cherry-flavoured pill disperses quickly in small amounts of water, easing administration and ensuring effective dosing for children. Coartem Dispersible is expected to help promote better outcomes from treatment, and delay the development of drug resistant strains of the disease.
Like Coartem tablets, Coartem Dispersible will be provided to the public sector without profit, to benefit those people most in need in the developing world.
In addition to Swissmedic, Coartem Dispersible has been approved by regulatory authorities in several countries in Africa. These include Benin, Burkina Faso, Democratic Republic of Congo, Gabon, Ghana, Guinea, Côte d’Ivoire, Kenya, Madagascar, Mauritania, Niger, Nigeria, Senegal and Togo.