The print issue of the publication will be available in the June 21, 2007, issue of the NEJM. The article, "Injectable Paromomycin for Visceral Leishmaniasis in India," was authored by Shyam Sundar, M.D., T.K. Jha, M.D., Chandreshwar P. Thakur, M.D., Prabhat K. Sinha, M.D., and Sujit K. Bhattacharya, M.D., Principal Investigators in the Phase 3 clinical trial. The article is accessible online, and can be found at www.nejm.org under the "Current Issue" section of the Web site.
The researchers conducted a randomized, controlled, phase 3 study comparing Paromomycin, an aminoglycoside, and amphotericin B, the present standard of care in Bihar, India. Paromomycin was shown to be noninferior to amphotericin B with a final cure rate of 94.6% vs. 98.8% for amphotericin. Paromomycin also had an acceptable safety profile, which included mild injection-site pain in 55% of patients and transient increases in liver function values in 6% of patients. The NEJM reports that Paromomycin may be advantageous because of the shorter duration of its administration (21 days versus 30 days for amphotericin B), its demonstrated safety and efficacy in pediatric patients (96%) and in patients who failed to be cured with other medicines (98%).
The NEJM article concluded, "The healthcare delivery system in India is well suited to the intramuscular administration of Paromomycin under directly observed therapy, and the local manufacture of Paromomycin in India, potentially at a very low cost, makes this an approachable therapy in the setting of limited resources."
Earlier this year, the World Health Organization (WHO) selected
Paromomycin IM Injection for inclusion on its Model List for
Essential Medicines. The WHO List of Essential Medicines provides a
model for countries to select medicines addressing public heal