New Delhi, Oct. 21: A new synthetic molecule launched by an Indian drug company last year against malaria caused by the Plasmodium falciparum parasite has now also been approved by India’s drug regulators to treat Plasmodium vivax malaria.
The Central Drugs Standard Control Organisation (CDSCO), New Delhi, has approved the drug named Synriam produced by Ranbaxy Laboratories for the treatment of malaria caused by the Plasmodium vivax parasite, the company announced today.
Ranbaxy had launched Synriam in April 2012, pitching it as an alternative to standard anti-malarial therapy against Plasmodium falciparum malaria. Clinical trials suggest that Synriam has a cure rate of over 95 per cent, the company said.
The company said the approval for the second parasite is significant for India where, according to the World Health Organisation, 50 per cent of the estimated 1.3 million cases of malaria each year are caused by Plasmodium vivax.
The drug, a combination of two molecules — arterolane maleate and piperaquine phosphate, has been approved specifically to treat uncomplicated (non-cerebral) malaria cases only in adults. But the CDSCO has given permission to Ranbaxy to begin clinical trials of a paediatric formulation of Synriam intended for children with uncomplicated malaria.
Since its launch, Synriam has been used in more than one million patients, the company has claimed. The drug is available in India for Rs 130 for three tablets. Standard treatment involves one tablet for three days.
The drug is intended to serve as an alternative to anti-malarial therapy based on a compound called artemisinin derived from a plant. The company said Synriam is a synthetic molecule and thus will not be vulnerable to price fluctuations and supply constraints that affect artemesinin.