Lupin announces USFDA acceptance for bacterial vaginosis drug

Lupin on Thursday announced that the USFDA has approved the company's supplemental New Drug Application to expand the use of SOLOSEC (secnidazole) in the treatment of bacterial vaginosis.

The drug will be used 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.

Secnidazole oral granules is the first and only single-dose oral prescription approved to treat both bacterial vaginosis (BV), a common vaginal infection. The drug is designed to be easy to take and one oral dose contains a complete course of treatment.

Tom Merriam, executive director - Specialty of Lupin 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).

Lupin is a transnational pharmaceutical company. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs.

Lupin's consolidated net profit jumped 24.47% to Rs 545.52 crore on a 3.57% rise in total revenue from operations to Rs 4160.93 crore in Q3 FY22 over Q3 FY21. Consolidated profit before tax (PBT) dropped 68.16% to Rs 167.08 crore in Q3 FY22 from Rs 524.84 crore in Q3 FY21. Total tax rebate during the quarter stood at Rs 382 crore in Q3 FY22 as against a tax expense of Rs 83.49 crore in Q3 FY21.

Shares of Lupin were trading 0.07% higher at Rs 772.10 in early trade.

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