Lupin Announces FDA Approval of SOLOSEC (secnidazole)

Mumbai, Baltimore, February 17, 2022: Lupin Pharmaceuticals Inc., (Lupin) today announced that the U.S. Food and Drug Administration 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. The supplemental adolescent approval enhances SOLOSEC’s strong position as the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV.

“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 adherence5, and may reduce risk factors associated with BV and trichomoniasis6-7, 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.”

DOSAGE AND ADMINISTRATION
SOLOSEC is a single-dose therapy for oral use. 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. SOLOSEC is not intended to be dissolved in any liquid. Avoid consumption of alcoholic beverages and preparations containing ethanol or propylene glycol during treatment with SOLOSEC and for at least 2 days after completing therapy.