About Visceral Leishmaniasis
VL is a systemic infection caused by various species of Leishmania parasites. The infection is transmitted by sandflies and causes chronic fever, weight loss, splenomegaly, hepatomegaly and anemia. Left untreated, VL is nearly always fatal. VL currently occurs in 62 countries, primarily in the developing world. Of the approximately 500,000 new cases of VL occurring annually, 90% are found in just five countries: India, Bangladesh, Nepal, Sudan and Brazil. South Asia carries 70% of all estimated new VL cases per year worldwide, with India alone carrying 50% of all new cases. The most affected state in India is Bihar, but VL is also endemic in the states of Jharkand, West Bengal, and Uttar Pradesh.
About Paromomycin Phase 3 Clinical Trial
The approval of Paromomycin IM Injection in India is based on data from a large Phase 3 multi-center, randomized, controlled study of 667 adult and pediatric patients conducted in Bihar State, India over a 17-month period from June 2003 until November 2004. Paromomycin was shown to cure 94.6% of patients with VL, with an acceptable side effect profile. The most common adverse reaction among patients treated with Paromomycin was mild pain at the injection site.
About Paromomycin IM Injection
An off-patent aminoglycoside antibiotic, paromomycin is an established drug with an extensive and well-characterized safety profile. Paromomycin IM Injection is now available from Gland Pharmaceuticals (Hyderabad, India) for the first time as a new treatment of VL in India as a once-a-day injection for 21 days. The cost of Paromomycin IM Injection is significantly lower than other currently approved VL therapies.
About the Institute for OneWorld Health
The Institute for OneWorld Health, the first US non-profit
pharmaceutical company, develops safe, effective and affordable
medicines for people with