Ranbaxy Laboratories has obtained regulatory approval to introduce India's first new chemical entity (NCE) Synriam (arterolane maleate 150mg and piperaquine phosphate 750mg drug) in seven African countries.
Synriam is a new age therapy recommended to treat uncomplicated Plasmodium falciparum malaria in adults. It was launched in India in April 2012.
The product was also launched in Uganda and is set to be introduced in Nigeria, Senegal, Cameroon, Guinea, Kenya and Ivory Coast by the end of January 2015.
Ranbaxy Laboratories CEO Arun Sawhney said: "Most malaria cases and deaths occur in sub-Saharan Africa.
"Synriam is among the best options available today as it is highly effective, affordable and a convenient therapy option, leading to better compliance.
"We are confident that the drug will help the government and healthcare system in Africa to fight the menace of malaria."
The new drug fulfils recommendations from World Health Organisation (WHO) for using as combination therapy in malaria. It provides quick relief from most malaria-related symptoms including fever.
The company carried out a double blind, randomised, multi-centre, Phase III clinical trial for the drug at multiple sites in Asia and Africa including India, Thailand, Bangladesh, Ivory Coast, Mozambique, Malawi, Senegal, Mali and Democratic Republic of Congo.
According to Ranbaxy, the study demonstrated that Synriam holds a comparable safety and efficacy profile to existing gold standard (fixed dose combination of artemether and lumefantrine 20mg and 120mg) to treat acute Plasmodium falciparum malaria in patients from the age of 12.
The company is also carrying out Phase III clinical trials for paediatric formulation of Synriam in paediatric patients of uncomplicated Plasmodium falciparum malaria.
Image: Very high magnification micrograph of maternal malaria. Photo: courtesy of Nephron.