Lupin Solosec gets USFDA nod to treat trichomoniasis, bacterial vaginosis in adolscents

Mumbai: Drugmaker, Lupin Pharmaceuticals Inc., has recently announced that the U.S. Food and Drug Administration (USFDA) has approved the company's supplemental New Drug Application (sNDA) to expand the use of SOLOSEC (secnidazole) in the treatment of bacterial vaginosis (BV) for female patients 12 years of age and older and in the treatment of trichomoniasis for all patients 12 years of age and older.

Bacterial vaginosis is a common vaginal infection and trichomoniasis is the most common non-viral, curable sexually transmitted infection in the U.S.

SOLOSEC is designed to be easy to take and one oral dose contains a complete course of treatment. The entire contents of SOLOSEC packet should be sprinkled onto applesauce, yogurt or pudding and consumed once within 30 minutes without chewing or crunching the granules. 

The FDA's approval expands the indication for SOLOSEC to treat adolescents and builds upon our commitment to support women's health. This expansion brings to health care professionals a treatment option for both BV and Trichomoniasis in Adolescents which provides a complete course of therapy in a single dose, one which helps to address gaps in care related to adherence , and may reduce risk factors associated with BV and trichomoniasis, such as other sexually transmitted diseases (STIs)," said Tom Merriam, Executive Director - Specialty, Lupin. "We are optimistic about this new treatment option for both healthcare practitioners and their adolescent patients."

Read also: Lupin gets USFDA nod to expand Solosec use for Trichomoniasis

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle East regions.  

Read also: Lupin, Exeltis ink agreement for Bacterial Vaginosis, Trichomoniasis drug SOLOSEC