 "Ranbaxy receives approval for malaria drug Synriam from 7 African countries")
Ranbaxy Laboratories Limited has received the regulatory approval to launch India’s first new chemical entity (NCE), Synriam (arterolane maleate 150 mg + piperaquine phosphate 750 mg drug) in seven African countries - Nigeria, Uganda, Senegal, Cameroon, Guinea, Kenya and Ivory Coast. The company has already launched the product in Uganda, while it is planning to introduce the product in other countries towards end of January 2015.
The new drug conforms to the recommendations of the World Health Organization (WHO) for using combination therapy in malaria. Synriam provides quick relief from most malaria-related symptoms, including fever, and has a high cure rate of over 95 per cent.
Arun Sawhney, CEO and managing director, Ranbaxy, said, “Most malaria cases and deaths occur in sub-Saharan Africa. It is the need of the hour to make available new therapy options to patients in the region. 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.”
Double-blind, randomised, multi-centre, Phase III clinical trial for the drug was conducted at multiple sites in Asia and Africa including India, Thailand, Bangladesh, Ivory Coast, Mozambique, Malawi, Senegal, Mali and Democratic Republic of Congo. This phase III clinical trial has demonstrated that Synriam(fixed dose combination of arterolane maleate and piperaquine phosphate 150+750 mg) has comparable safety and efficacy profile to existing gold standard (fixed dose combination of artemether and lumefantrine 20 +120 mg ) for treatment of acute uncomplicated Plasmodium falciparum malaria in patients aged 12 years and above.
Ranbaxy is also conducting phase III clinical trials for the paediatric formulation of Synriam in paediatric patients of uncomplicated Plasmodium falciparum malaria.
Synriam, a new age therapy recommended for the treatment of uncomplicated Plasmodium falciparum malaria in adults, was launched by Ranbaxy on World Malaria Day, April 25, 2012 in India. Since its launch, the drug has successfully treated around one million patients in the country.
The new drug conforms to the recommendations of the World Health Organization (WHO) for using combination therapy in malaria. Synriam provides quick relief from most malaria-related symptoms, including fever, and has a high cure rate of over 95 per cent.
Arun Sawhney, CEO and managing director, Ranbaxy, said, “Most malaria cases and deaths occur in sub-Saharan Africa. It is the need of the hour to make available new therapy options to patients in the region. 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.”
Double-blind, randomised, multi-centre, Phase III clinical trial for the drug was conducted at multiple sites in Asia and Africa including India, Thailand, Bangladesh, Ivory Coast, Mozambique, Malawi, Senegal, Mali and Democratic Republic of Congo. This phase III clinical trial has demonstrated that Synriam(fixed dose combination of arterolane maleate and piperaquine phosphate 150+750 mg) has comparable safety and efficacy profile to existing gold standard (fixed dose combination of artemether and lumefantrine 20 +120 mg ) for treatment of acute uncomplicated Plasmodium falciparum malaria in patients aged 12 years and above.
Ranbaxy is also conducting phase III clinical trials for the paediatric formulation of Synriam in paediatric patients of uncomplicated Plasmodium falciparum malaria.
Synriam, a new age therapy recommended for the treatment of uncomplicated Plasmodium falciparum malaria in adults, was launched by Ranbaxy on World Malaria Day, April 25, 2012 in India. Since its launch, the drug has successfully treated around one million patients in the country.