Secnidazole

Lupin Announces FDA Approval of Supplemental New Drug Application for SOLOSEC® (secnidazole) in Adolescents for both the Treatment of Bacterial Vaginosis in Females and Trichomoniasis

Retrieved on: 
Thursday, February 17, 2022

"The FDA's approval expands the indication for SOLOSEC to treat adolescents and builds upon our commitment to support women's health.

Key Points: 
  • "The FDA's approval expands the indication for SOLOSEC to treat adolescents and builds upon our commitment to support women's health.
  • Vulvovaginal candidiasis may develop with SOLOSEC and require treatment with an antifungal agent.
  • To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-844-SOLOSEC (1-844-765-6732) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
  • SOLOSEC is a registered trademark of Lupin Inc. and LUPIN is a registered trademark of Lupin Pharmaceuticals, Inc.

Lupin Signs Promotional Agreement with Exeltis on SOLOSEC® (secnidazole) expanding access for Adult Women Suffering with Bacterial Vaginosis and Adults with Trichomoniasis

Retrieved on: 
Thursday, January 27, 2022

Exeltis' overarching goal is to support and care for women throughout every stage of life.

Key Points: 
  • Exeltis' overarching goal is to support and care for women throughout every stage of life.
  • [1]
    SOLOSEC (secnidazole) 2 g oral granules is an antimicrobial agent indicated for the treatment of bacterial vaginosis in adult women and trichomoniasis in adults.
  • SOLOSEC is a registered trademark of Lupin Inc. and LUPIN is a registered trademark of Lupin Pharmaceuticals, Inc.
  • The prevalence of bacterial vaginosis in the United States, 2001-2004; associations with symptoms, sexual behaviors, and reproductive health.

Lupin Announces FDA Approval of Supplemental New Drug Application for SOLOSEC® (secnidazole) for the Treatment of Trichomoniasis

Retrieved on: 
Thursday, July 1, 2021

[1] SOLOSEC was approved in the U.S. in 2017 for the treatment of bacterial vaginosis (BV) in adult women.

Key Points: 
  • [1] SOLOSEC was approved in the U.S. in 2017 for the treatment of bacterial vaginosis (BV) in adult women.
  • The supplemental approval makes SOLOSEC the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV.
  • Research demonstrates that approximately 70% of women with trichomoniasis are PCR positive for BV,[2]" said Jon Stelzmiller, President Specialty, Lupin Pharmaceuticals, Inc.
  • SOLOSEC(secnidazole) 2 g oral granules is an antimicrobial agent indicatedfor the treatment of BV in adult women and trichomoniasis in adults.

Lupin Announces SOLOSEC® (secnidazole) Achievement of Preferred Status on Express Scripts National Preferred Formulary, One of the Largest Commercial Formularies in the U.S.

Retrieved on: 
Wednesday, April 22, 2020

As a preferred medication, Solosec will be available at a lower out-of-pocket cost to the represented Express Scripts plan members compared to BV medications which are non-preferred or excluded.

Key Points: 
  • As a preferred medication, Solosec will be available at a lower out-of-pocket cost to the represented Express Scripts plan members compared to BV medications which are non-preferred or excluded.
  • "We believe our pricing and access strategy prioritizes patients by providing a novel, first-of-its-kind BV treatment at pricing designed to reduce barriers to treatment with Solosec."
  • SOLOSEC (secnidazole) 2g oral granules is a 5-nitroimidazole antimicrobial agent indicated for the treatment of bacterial vaginosis (BV) in adult women.
  • SOLOSEC is contraindicated in patients with a history of hypersensitivity to secnidazole, other ingredients of the formulation, or other nitroimidazole derivatives.