Ranbaxy Laboratories has secured approval from India's Central Drugs Standard Control Organisation (CDSCO) to manufacture and sell 'Synriam' to treat uncomplicated malaria caused by Plasmodium vivax parasite in adult patients.
Phase III clinical trials of Synriam, an arterolane maleate and piperaquine phosphate tablet 150+750mg, conducted in India showed the efficacy and tolerability of the drug as comparable to chloroquine.
The company also received permission to carryout Phase III clinical trials for the pediatric formulation in pediatric patients of uncomplicated Plasmodium falciparum malaria.
Ranbaxy managing director and CEO Arun Sawhney said Synriam is a new age cure for malaria and is fast emerging as the preferred option in the hands of doctors.
"This approval makes Synriam one of the few therapies in the world that successfully treats both, Plasmodium vivax and Plasmodium falciparum malaria," Sawhney said.
In order to make this new treatment available in African, Asian and South American markets where malaria is rampant, the company has submitted New Drug Applications (NDAs) for marketing Synriam in some African countries and will file more applications by year end.
After approval from the authorities, the company will launch the drug in these markets, which is claimed to offer quick relief from most malaria-related symptoms, including fever and has a high cure rate of over 95%.
In April 2013, Ranbaxy had introduced Synriam to treat patients with uncomplicated Plasmodium falciparum malaria in India.
According to the company, 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.