The project finalises the development of an antimalarial in suppository
formulation for emergency treatment of life-threatening malaria. The intended
beneficiary is a patient living in or travelling to a malaria endemic country.
The drug is to be developed to provide therapeutic cover for patients with
severe disease, who can no longer take drugs by mouth, and who cannot access
injectable treatment, until they reach facilities where definitive therapy can
Survival from severe malaria depends upon speed of chemotherapy.
Patients with malaria who are not able to take fluids and medicines by mouth,
and who do not have ready access to treatment by reason of the distance at which
they live from a health facility, are at considerable risk of deteriorating and
dying before getting to a clinic where effective treatment is available. This is
how most lives are lost from acute Plasmodium falciparum infection,
particularly amongst infants and children, and especially in the rural areas of
sub-Saharan Africa, South East Asia and the Indian sub-continent. Therefore the
development, registration and introduction of a therapy that substitutes for an
injectable drug, allowing emergency treatment for patients unable to reach a
hospital, has a realistic prospect of saving lives of infants, children and
adults with malaria of a severity that is potentially life-threatening, and
where at present no treatment is available.
The project aims to develop a safe and effective emergency treatment for
acute life threatening malaria for patients in malaria endemic areas who cannot
access injectable treatment quickly, and therefore die.
- Development of a high quality, efficacious antimalarial drug for use in
European Union countries and the United States.
- Critical assessment of the efficacy of the drug as given in conditions of
use. Development and implementation of a safety register to monitor safety of
the drug in one site.
- A drug available for travellers who could have a very high case-fatality
rate from malaria.
- An added value to the development of oral artesunate-combination therapy for
malaria to halt the spread of drug resistance.
The development of a rectal formulation of artesunate, a semi-synthetic
derivative of artemisinin, for substantially reducing the risk of a fatal
outcome in patients (mainly infants and children) with life-threatening malaria
is a primary tool for reducing the burden of malaria in malaria endemic areas.
The drug will be placed on the National Essential Drugs’ list.
Special Programme for Research and Training in Tropical Diseases
World Health Organisation
Avenue Appia 20
1211 Geneva 27
Tel: +41 22 791 3813
Fax: +41 22 791 4774
|2||Birna Trap, Financial Coordinator||Euro Health Group|
DK-2860 Soborg, Copenhagen
|Tel: +45 39 696888|
Fax: +45 39 695888
|3||Robert Carter||Knoll Ag|
|Tel: +41 61 921 0505|
Fax: +41 61 921 2563
|4||Sornchai Looareesuwan Dean||Faculty of Tropical Medicine|
42/46 Rajvithi Road
|Tel: +66 2 247 1688|
Fax: +66 2 647 1688
|5||W. Bossert||R P Scherer GmbH|
DE-69402 Eberbach Baden
|Tel: +49 6271 843325|
Fax: +49 6271 843700
|6||John O Gyapong|
|Health Research Unit|
Ministry of Health
P O Box 184
|Tel: +233 21 230220|
Fax. +233 21 226739
|7||Peter Folb||Groote Schuur Hospital Observatory , Department of Pharmacology|
P O Box 7925
K 435 Old Main Building
|Tel: +27 21 406 6286|
Fax. +27 21 448 6181