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.
On the occasion, Arun Sawhney, chief executive officer, 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 pediatric formulation of Synriam in paediatric patients of uncomplicated Plasmodium falciparum malaria.
Every year around 169 million people in Nigeria and around 32 million people in Uganda are at the risk of malaria. In Nigeria, Malaria contributes to an estimated 11 per cent of maternal mortality. It is the number one public health problem in Guinea and according to national health statistics, the morbidity rate for malaria is 148/1000 population. The disease is endemic throughout Senegal, and the entire population (approximately 13.4 million) is at risk. Vulnerable groups comprise about 2.2 million children under five and 0.5 million pregnant women. About 70 per cent of the Kenyan population is at risk for malaria. Plasmodium falciparum is the most predominant parasite species accounting for maximum malaria cases in these countries.
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.
There was a critical need for a new anti-malaria drug that would address the existing challenges of resistance to available drugs, price fluctuations, supply constraints and high pill burden. Synriam address all these issues that are associated with the most commonly used therapies and is highly effective.
Synriam , is a new age therapy recommended for the treatment of uncomplicated Plasmodium falciparum malaria, in adults. Synriam 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 India.