Lupin Pharmaceuticals gets FDA approval for SOLOSEC sNDA

Lupin Pharmaceuticals has secured approval from the US Food and Drug Administration for its supplemental new drug application (sNDA) to expand the indication of SOLOSEC (secnidazole) in the treatment of bacterial vaginosis (BV) for female patients, aged 12 and more and in the treatment of trichomoniasis for all patients, aged 12 and more.

Bacterial vaginosis is a commonly prevailing vaginal infection, while trichomoniasis is a common non-viral, sexually transmitted infection in the US.

According to Lupin Pharmaceuticals, the supplemental adolescent approval boosts SOLOSEC’s position as the first and only single-dose oral prescription antimicrobial agent indicated for the treatment of trichomoniasis as well as bacterial vaginosis.

Tom Merriam — Lupin Pharmaceuticals Specialty Executive Director said: “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).”

Last month, Lupin Pharmaceuticals had signed an agreement with Exeltis USA to promote the latter’s antimicrobial drug Solosec in the US market.