Drug Development Global Program

Expanding the toolbox of medicines for visceral leishmaniasis

Visceral leishmaniasis (VL), also known as kala-azar or black fever, is strongly associated with poverty and malnutrition. An estimated 200,000 to 400,000 new cases of VL occur worldwide each year with more than 90 percent of the burden falling in six countries—Bangladesh, Brazil, Ethiopia, India, South Sudan, and Sudan.1 The disease is transmitted through the nearly undetectable bite of infected sandflies, which are small enough to pass through most mosquito netting. VL affects the visceral organs, causing chronic fever, weight loss, and anemia. In more than 95 percent of cases, it is fatal if left untreated.

Paromomycin, an off-patent aminoglycoside antibiotic, is an established drug with an extensive history of use and a well-characterized safety profile. PATH and our partners worked to develop paromomycin intramuscular injection (PMIM) as an effective and safe treatment for VL. We also collaborated with leading clinical researchers and the Indian pharmaceutical company Gland Pharma to manufacture the treatment.

PMIM has been registered with the national drug development agencies of India (2006), Nepal (2012), and Uganda (2012). It is also included on the World Health Organization Model List of Essential Medicines. Registration for PMIM is ongoing in Bangladesh, Ethiopia, Kenya, and Sudan.

PATH is collaborating with partners to implement pharmacovigilance programs in Nepal and Bangladesh. These programs aim to strengthen patient safety and care associated with the use of VL drugs. The results of the pharmacovigilance activities are summarized in an ongoing newsletter series.

PATH is also conducting a multicenter demonstration study of the use of combination therapies (PMIM + miltefosine and PMIM + liposomal amphotericin B) for treatment of VL in government hospitals located in endemic districts of Nepal, with a goal of assessing the acceptability and compliance of these combination therapies in public health settings.

1. Leishmaniasis: burden page. World Health Organization website. Available at: http://www.who.int/leishmaniasis/burden/en/. Accessed July 18, 2016.