Description

Arteether (INN) is a semi synthetic derivative of artemisinine, the active constituent of the plant Artemisia annua. CDRI conducted extensive preclinical, toxicological and other regulatory studies in which the drug was not only found to be very safe but also proved to be a fast acting, blood schizontocidal agent which attacks at the erythrocytic stage of malaria in blood. Extensive clinical trials were conducted at 7 centres in malaria prone areas of India. Over 500 patients showed excellent response and the recrudescent rate was very low. Arteether has been developed by CDRI and is being prescribed to the patients as second line of treatment for chloroquine-resistant P. falciparum malaria including cerebral malaria.

Though choloroquine has been and still remain one of the most extensively used first line drug for malaria, resistance against this drug is quite frequent. Search for a drug which could be more effective than chloroquine and which could minimize the chance of resistance development has been going on the world over. CDRI has always been quite in the forefront in searching for natural or synthetic drug that could be used as a weapon to fight malaria since it is causing so much of devastation in tropical countries, especially India. Many plants used by traditional systems of medicine have been tried and many of the leads are being pursued.

CDRI got a major success when it developed Arteether from the plant Artemisia annua while working in collaboration with, Central Institute of Medicinal and Aromatic plants (CIMAP), the other CSIR laboratory based at Lucknow.

The Drugs Controller General (India) has allowed the drug exclusively for use in hospitals and nursing homes.

Being a new drug, it is indicated for use only in severe P. falciparum malaria including cerebral malaria as a second line treatment for chloroquine resistant cases. It is not recommended to be used as a first line treatment for malaria to avoid its overuse which may lead to the emergence of resistance against this drug once again.

CDRI has licensed the drug to Themis Chemicals Ltd., Mumbai which is marketing it under the trade name E-Mal as an injectable formulation.

Post marketing surveillance data on 400 patients received from clinicians from 6 states has validated the efficacy and safety of Arteether in uncomplicated/complicated cases of P.falciparum malaria. No drug related side effects have been observed so far.