India has developed a powerful new malaria drug - an alternative to the global drug of choice Artemisinin - that promises to be a major boost to India's pharmaceutical research.
What is most exciting about this new drug is that its raw materiel is synthetic (derived chemically in the lab) as against Artemisinin, which is derived from a plant.
Union health minister Ghulam Nabi Azad and Ranbaxy will unveil India's first new chemical entity (NCE) against the P falciparum malaria on Wednesday to commemorate the World Malaria Day.
Dr Neena Valecha from the National Institute of Malaria Research (NIMR) said this new once-a-day therapy for three days contains Arterolane and Piperaquine.
"Clinical trials conducted by NIMR comparing the Arterolane and Piperaquine combination has shown it to be as effective and as safe as artemisinin combinations like Artesunate and Sulphadoxine which is used in the national malaria programme," said Dr Valecha, who was the principal investigator of the trials.
Artemisinin derivatives are most rapid acting and effective anti-malarial medicines, according to her.
Artemisinin is the only high-volume drug that continues to be produced from a plant-based source. China and Vietnam provide 70% and East Africa 20% of the raw material. Seedlings are grown in nurseries and then transplanted into fields. It takes about eight months for them to attain full size. The plants are harvested, leaves dried and sent to facilities where artemisinin is extracted. The market price for artemisinin has fluctuated widely, between $120 and $1,200 per kg from 2005 to 2008.
"However, they are plant derived and, therefore, there can be mismatch in demand and supply. It is used in combination with different drugs (artemisinin-based combination therapy). Now, five combinations are recommended by WHO. On the other hand, since this new drug is synthetic, its raw materials are created chemically in the lab. This will ensure constant supply of raw materiel and standardize costs," added Dr Valecha.
Arterolane in combination with long acting piperaquine has been studied in phase II and III clinical trials in India, Bangladesh and Thailand. Most malaria parasites have become resistant to anti-malarial drugs.
To protect artemisinin from developing resistance, it is recommended that it should only be used in combination with partners and oral artemisinin should never be used as monotherapy. The Drugs Controller General of India has imposed a ban on use of oral artemisinin monotherapy for uncomplicated falciparum malaria.
Artemisinin resistance is characterized by slow parasite clearance. Artemisinin Combination Therapies (ACT) kills malaria parasite in a human bloodstream within 24-36 hours. With the drug-resistant strain, ACT needs up to 120 hours to kill the parasite.
India records 1.5 million cases of malaria every year, 50% of which are caused by the falciparum malaria. Officially, an estimated 18,000 die of malaria in the country.
"Combination therapy is a deliberate strategy to delay the development of drug resistance. ACTs deliver a two-punch attack on the malaria parasite. By combining drugs with different mechanisms of action and different time spans of activity, ACTs increase the likelihood that any parasites not killed by one drug will be killed by the second one. The usefulness of these therapies is now under threat," said WHO director general Margaret
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