Synriam provides quick relief from most malaria-related symptoms, including fever and has a high cure rate of over 95 per cent
Ranbaxy Laboratories has received the regulatory approval to launch India’s first NCE (New Chemical Entity), Synriam (arterolane maleate 150 mg + piperaquine phosphate 750 mg drug) in seven African countries viz. Nigeria, Uganda, Senegal, Cameroon Guinea, Kenya and Ivory Coast. The product has since been launched in Uganda and will be made available 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.
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. The dosage regimen for Synriam is simple as the patient is required to take just one tablet per day, for three days, compared to other medicines where two to four tablets are required to be taken, twice daily, for three or more days. This makes Synriam a convenient option, leading to better compliance. The drug is also independent of dietary restrictions for fatty foods or milk, as is the case with older anti-malarial therapies. Since Synriam has a synthetic source, unlike artemisinin-based drugs, production can be scaled up whenever required and a consistent supply can be maintained at a low cost.