Overview
Malaria is a protozoan disease that places an enormous burden on human health in endemic areas around the world. The 2020 World Health Organization malaria report indicates a 60% decrease in the global malaria fatality rate between 2000 to 2019. Despite this, malaria remains a significant cause of morbidity and mortality; 90% of deaths from malaria occur in Africa. Individuals at the highest risk for malaria are those in disease naïve populations, children under age 5, refugees in Central and Eastern Africa, nonimmune civilian and military travelers, pregnant women, and immigrants traveling to their place of origin. Mefloquine, commonly known as Lariam, is an antimalarial drug used for the prevention and treatment of malaria caused by infection with Plasmodium vivax and Plasmodium falciparum. The drug was initially discovered by the Walter Reed Army Institute of Research (WRAIR) during a malaria drug discovery program between 1963 until 1976. It was approved by the FDA in 1989, and was first marketed by Hoffman Laroche. This drug has been the subject of widespread controversy due to concerns regarding neurotoxic effects; product information warns of potential serious neuropsychiatric effects.
Indication
Mefloquine is indicated for the treatment of mild to moderate cases of malaria caused by Plasmodium falciparum and Plasmodium vivax. It is effective against chloroquine-resistant forms of Plasmodium falciparum. Mefloquine is also indicated for the prophylaxis of malaria caused by Plasmodium falciparum and Plasmodium vivax, including chloroquine-resistant forms of Plasmodium falciparum.
Associated Conditions
- Malaria caused by Plasmodium falciparum
- Malaria caused by plasmodium vivax
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2021/04/19 | Phase 2 | Completed | |||
2020/04/15 | Phase 2 | Completed | Burnasyan Federal Medical Biophysical Center | ||
2015/11/24 | Phase 1 | Completed | |||
2015/08/14 | Phase 1 | Completed | ORIYOMI OMOTOYOSI AKINYOTU | ||
2015/07/02 | Phase 2 | Completed | U.S. Army Medical Research and Development Command | ||
2015/07/02 | Phase 2 | Completed | U.S. Army Medical Research and Development Command | ||
2014/12/24 | Phase 4 | Completed | |||
2014/03/12 | Phase 4 | Completed | Instituto Nacional de Salud. Peru | ||
2013/11/06 | Phase 4 | Completed | Global Emerging Infections Surveillance and Response System | ||
2013/09/11 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Physicians Total Care, Inc. | 54868-5434 | ORAL | 250 mg in 1 1 | 1/12/2010 | |
Hikma Pharmaceuticals USA Inc. | 0054-0025 | ORAL | 250 mg in 1 1 | 1/14/2021 | |
H.J. Harkins Company, Inc. | 52959-803 | ORAL | 250 mg in 1 1 | 2/8/2012 | |
Teva Pharmaceuticals USA, Inc. | 0555-0171 | ORAL | 250 mg in 1 1 | 2/16/2023 | |
A-S Medication Solutions | 50090-2396 | ORAL | 250 mg in 1 1 | 5/31/2016 | |
Rebel Distributors Corp | 21695-449 | ORAL | 250 mg in 1 1 | 2/22/2006 | |
Rebel Distributors Corp | 21695-561 | ORAL | 250 mg in 1 1 | 8/5/2011 | |
NuCare Pharmaceuticals,Inc. | 68071-4702 | ORAL | 250 mg in 1 1 | 2/17/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
LARIAM mefloquine 250mg tablets | 43321 | Pharmaco Australia Ltd | Medicine | A | 1/27/1993 |
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