Short-course fixed-dose combination with long shelf-life decreases risk of resistance emerging

Easy-to-use malaria treatment with high cure rates

With older antimalarial medicines becoming less effective due to growing drug resistance, in 2001 WHO recommended the use of artemisinin-based combination therapies as the primary type of malaria treatment.

However, there were no combinations of the recommended drugs. People had to take each drug separately, which is more complicated and increases the chances of drug resistance developing due to people not taking the full and correct dose of both medicines.

DNDand Farmanguinhos/Fiocruz partnered to combine two malaria drugs that had been widely used in Asia and Latin America for the last 20 years: artesunate and mefloquine. The partnership developed ASMQ – a tablet that is a fixed-dose combination of these two drugs. DNDi and its partners conducted several clinical trials to test its safety and effectiveness.

ASMQ is suitable for adults, children, and infants from 6 months of age, which is vital since children under five are most at risk of dying from malaria. ASMQ is easy-to-use because patients need to take just one dose per day for three days. Giving the medicine to infants and young children is easier because the tablets can be disintegrated in water. ASMQ has a three-year shelf-life in tropical conditions.

ASMQ offers a long period of protection after treatment and has a key role in the Greater Mekong Subregion, where there is increasing drug resistance. ASMQ was released at cost price to make it affordable and reach patients.

  • Indication: Malaria
  • Dosage: Single daily fixed-dose combination of artesunate & mefloquine for 3 days

Impact

  • Registered in 11 countries and territories in Asia, Latin America, and Africa
  • More than 1.2 million treatments distributed since 2008
  • Recommended first or second-line treatment in five countries in Latin America and four countries in South-East Asia
  • No patent: developed as a public good, so any generic company meeting quality standards can produce it
  • Included in the Essential Medicines List (EML) and Essential Medicines List for children (EMLc) in 2013
  • Technology transfer from Brazilian public sector laboratory Farmanguinhos/Fiocruz to Indian generic company Cipla in 2010
  • Cipla’s product was prequalified by WHO in 2012

History – the FACT project

In response to WHO’s recommendation of artesunate combination therapies to treat malaria, Médecins Sans Frontières, the WHO Special Programme for Research and Training in Tropical Diseases, and other partners established the Fixed-Dose-Artesunate Combination Therapy (FACT) project in 2002. When DNDi was created in 2003, it took over management of the FACT project.

FACT’s objective was to develop two fixed-dose combination therapies containing artemisinin for the treatment of malaria. The urgency of these goals was confirmed by WHO’s 2006 malaria treatment guidelines calling for an immediate halt to artemisinin monotherapy, to prevent the creation of drug resistance. ASMQ was first released in 2008.

‘At night his body was very hot – he was sweating and vomiting. He looked very sick, so I decided to bring him at the hospital. The doctors found he had malaria. There is a lot of malaria in my community because of the rain. I am very happy now because he was treated.’

Mother of three-year old Michele who was treated with ASMQ, Ahero district, Kisumu, Kenya

More information

Key scientific article:

Pharmacokinetics of co-formulated mefloquine and artesunate in pregnant and non-pregnant women with uncomplicated Plasmodium falciparum infection in Burkina Faso. Journal of Antimicrobial Chemotherapy, June 2014
by Valea I, Tinto H, Traore/Coulibaly M, Toe Niklas Lindegardh LC, Tarning J, Van Geertruyden JP, D’Alessandro U, Davies GR, Ward SA.

Press pack:

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*Project cost includes direct and indirect costs, but it does not include in-kind contributions.