Ranbaxy Laboratories Limited (Ranbaxy) today announced that the company has received approval from the Central Drugs Standard Control Organisation (CDSCO), Government of India, to manufacture and market SynriamTM (arterolane maleate and piperaquine phosphate tablet 150+750 mg) for the treatment of uncomplicated malaria in adults caused by the Plasmodium vivax parasite.
Phase III clinical trials for the drug conducted in India successfully demonstrated the efficacy and tolerability of Synriamâ„ as comparable to chloroquine.
Last year on World Malaria Day, April 25, Ranbaxy had launched Indias first new drug, SynriamTM, for the treatment of uncomplicated Plasmodium falciparum malaria in the country. Since its launch, SynriamTM has successfully treated around one million patients.
The company has also received permission to conduct Phase III clinical trials for the pediatric formulation in pediatric patients of uncomplicated Plasmodium falciparum malaria.
Commenting on the approval, Arun Sawhney, CEO & Managing Director, Ranbaxy, said, SynriamTM is a new-age cure for malaria and is fast emerging as the preferred option in the hands of doctors. This approval makes SynriamTM one of the few therapies in the world that successfully treats both, Plasmodium vivax and Plasmodium falciparum malaria. Ranbaxy remains committed in its fight against malaria and we are making all efforts to make this new therapy accessible to patients around the world.
Ranbaxy is working to make this new treatment available in African, Asian and South American markets where Malaria is rampant. The company has filed New Drug Applications (NDAs) for marketing SynriamTM in some African countries and will be filing in more applications during the year. Once approved, the product will be launched in these markets.
SynriamTM provides quick relief from most malaria-related symptoms, including fever, and has a high cure rate of over 95%. It conforms to the recommendations of the World Health Organization (WHO) for using combination therapy in malaria.
As the dosage regimen for SynriamTM is simple, it leads to better compliance. A 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. The drug is also independent of dietary restrictions for fatty foods or milk, as is the case with older anti-malarial therapies. Since SynriamTM 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.
According to the World Malaria Report 2012 published by WHO, India sees about 1.3 million confirmed cases of malaria each year, about 50% of which are caused by Plasmodium vivax, the second most important species after Plasmodium falciparum. Worldwide, 40% of the total malaria burden globally is due to Plasmodium vivax , which shows the vast potential of SynriamTM in India and globally.
Traditional drugs are proving ineffective against the deadly malarial parasite because it has progressively acquired marked resistance to available drugs. The availability of plant-based Artemesinin, a primary ingredient in established anti-malarial therapies, is finite and unreliable. This leads to price fluctuations and supply constraints, which is not the case with a synthetic drug like SynriamTM.