Paromomycin Phase IIIb trial in VL successfully completed in Bangladesh
PATH (Program for Appropriate Technology in Health)'s Drug Development programme has reported the successful completion of a Phase IIIb trial in Bangladesh for the antibiotic, paromomycin intramuscular injection (PMIM), developed to treat visceral leishmaniasis (VL). The trial investigated the safety and efficacy of PMIM monotherapy among 120 patients residing in VL-endemic areas of the country. It enrolled its first patient in January 2011 and was carried out at two sites through government-run public health centres. Findings from this study will support efforts to register PMIM in Bangladesh and ultimately contribute to the national VL elimination strategy.
Paromomycin, an off-patent aminoglycoside antibiotic, is an established drug with an extensive history of use and a well characterised safety profile. OneWorld Health developed PMIM as an effective, inexpensive and safe treatment for VL, and worked with leading clinical researchers and Gland Pharmaceuticals to manufacture the treatment. The cost of a course of treatment with PMIM as a monotherapy for 21 days is less than US$20, which is significantly lower than other currently-approved VL therapies. PMIM is recommended by the World Health Organization as a preferred combination therapy to treat VL in South Asia. PMIM is also registered with the drug regulatory agencies of India, Nepal and Uganda. A number of studies are evaluating PMIM for use in combination with other treatments as a key tool in global VL elimination strategy.