New support for rectal artesunate treatment for malaria
Medicines for Malaria Venture (MMV) is building on pivotal TDR studies to coordinate a development effort to bring a commercially manufactured version of the malaria treatment rectal artesunate through the WHO prequalification process.
Severe malaria impacts an estimated 8 million people per year; it results from inadequately treated uncomplicated malaria and can quickly lead to death, particularly in children. In the event that recommended parenteral (injected) treatment options are not readily available, the administration of the suppository form of rectal artesunate can buy critical time for patients in transit to treatment facilities.
TDR conducted a large scale placebo-controlled trial involving over 17 000 patients in Bangladesh, Ghana and Tanzania regarding the efficacy of pre-referral rectal artesunate. The trial demonstrated that "if patients with severe malaria cannot be treated orally and access to injections will take several hours, a single inexpensive artesunate suppository at the time of referral substantially reduces the risk of death or permanent disability."
MMV will work with TDR and pharmaceutical partners to establish a manufacturing solution for large scale production of rectal artesunate that will satisfy GMP requirements and be eligible for review by the WHO prequalification programme.
At the same time, TDR will continue to support implementation research which refines the indication, tests and scale-up delivery mechanisms to demonstrate impact in Africa and elsewhere.
For more information, please contact:
Melba Gomes E-mail:gomesm@who.int