Single-dose secnidazole demonstrated comparable efficacy to 7-day BID metronidazole regimen2
Secnidazole vs. Metronidazole for the Treatment of BV
(clinical cure at day 28[%])2*†
* A multicenter, double-blind, double-dummy randomized phase-III study comparing secnidazole and metronidazole.2
Clinical cure was defined as the normalization of the three Amsel criteria. 95% CI secnidazole-metronidazole [-0.098 ; 0.052].2
But as many as
50%
of patients DO NOT complete their full 7-day course of metronidazole.3
Your patients may be at increased risk for:
  • Pelvic Inflammatory Disease (PID)4
  • Acquisition of STIs (gonorrhea, chlamydia, HPV and HSV)5
  • Acquisition or transmission of HIV6
68%
of patients treated with SOLOSEC did not require any additional treatment for BV7
SOLOSEC demonstrated clinically and statistically significant efficacy in the treatment of BV.7,8
SOLOSEC: the only single-dose oral antibiotic for the treatment of BV1
2020 ACOG and 2021 CDC guidelines include single-dose SOLOSEC for the treatment of BV.10,11



Bacterial Vaginosis Study Design
  • This multi-center, prospective, randomized, comparative, double-blind, double-dummy, Phase-III, noninferiority study was designed to compare the efficacy of secnidazole versus metronidazole in patients with bacterial vaginosis.
  • Patients were randomized to metronidazole (reference treatment) or secnidazole (study treatment) in a 1:1 ratio. After randomization, patients received either a single 2 g dose of secnidazole or the reference treatment, that is, a seven-day course of 500 mg metronidazole twice daily.
  • The primary efficacy endpoint was the therapeutic success, that is, a composite of clinical and bacteriological cure, at day 28. Clinical cure was defined as the normalization of the three Amsel criteria and bacteriological cure was defined as a Nugent score ≤ 3.

SOLOSEC was superior to placebo in all primary and secondary endpoints.
Pivotal Study 1 Clinical Cure Rate*
p < 0.001
* Study design information below.
Study Overview:
  • Study 1 enrolled 215 nonpregnant female patients aged 19-54 years. 188 women were included in the modified intent to treat (mITT) group and were randomized to 1:1:1 to receive either secnidazole 1 g (N = 71), secnidazole 2 g (N = 72), or placebo (N = 72).
  • Reasons for exclusion from the mITT group included baseline STIs (n=13 women), Nugent score < 4 at start of study (n=14), and clinically significant baseline laboratory abnormality that led to a diagnosis of chronic myeloid leukemia (n=1). Patients missing ≥ 1 of the clinical assessments were considered non-responders/not cured.
Study Endpoints:
  • Efficacy was assessed at the test of cure (TOC) visit after 21-30 days in the mITT group, following initial treatment with a single dose of SOLOSEC.
  • The primary efficacy endpoint was clinical cure, defined as normal vaginal discharge, negative 10% KOH whiff test, and clue cells < 20% of total epithelial cells on microscopic examination at the TOC/EOS visit.
Safety Analysis
  • The safety and tolerability of secnidazole was also evaluated in all 215 patients who were treated with a single dose of the study drug. Secnidazole was well-tolerated. 19.4% of patients receiving 2 g secnidazole experienced an adverse event. All treatment-related, treatment-emergent adverse events were judged to be mild to moderate.

Study Overview:
  • Study 2 enrolled 189 nonpregnant female patients aged 18 – 54 years. Patients were randomized 2:1 to receive a single oral dose of secnidazole 2 g (N = 125) or matched placebo (N = 64).
  • Efficacy was assessed in the modified intent to treat (mITT) group at the interim visit after 7-14 days and at the test of cure (TOC) visit after 21-30 days, following initial treatment with a single dose of SOLOSEC.
  • The mITT group was the primary efficacy population. Patients were excluded from the mITT group if their Nugent score < 4 or if baseline laboratory tests revealed a positive infection for a separate sexually transmitted infection.
Study Endpoints:
  • The primary efficacy endpoint was the proportion of clinical outcome responders, defined as those with: (1) normal vaginal discharge; (2) negative 10% potassium hydroxide whiff test; and (3) < 20% clue cells of total epithelial cell count on microscopic examination of the vaginal wet mount, using saline at the test of cure/end of study visit (study days 21-30). In addition, based on FDA draft guidance issued in 2016, patients with baseline Nugent scores 7-10 were evaluated for clinical cure using the following clinical assessments on days 7-14: (1) resolution of the abnormal vaginal discharge; (2) negative KOH whiff test; and (3) clue cells < 20%. The investigator's clinical opinion regarding whether the patient required additional BV treatment was documented at the TOC visit.
  • Single-dose secnidazole was superior to placebo for all primary and secondary endoints in the mITT population. Significantly more patients receiving SOLOSEC required no additional BV treatment (68.0% [68/100] vs. 29.6% [16/54]; p < .001).
Safety Analysis
  • The safety and tolerability of secnidazole was also evaluated in all 189 patients who were treated with a single dose of the study drug. 34% of patients receiving 2 g secnidazole experienced an adverse event (AE). Most AEs were mild or moderate in intensity and nonserious, and none led to study discontinuation.
References:
1. SOLOSEC [prescribing information]. Baltimore, MD: Lupin Pharmaceuticals, Inc; 2021. 2. Bohbot JM, Vicaut E, Fagnen D, Brauman M. Treatment of bacterial vaginosis: a multi-center, double-dummy, randomized phase III study comparing secnidazole and metronidazole. Infect Dis Obstet Gynecol 2010;2010:1-6. 3. Bartley JB, Ferris DG, Allmond LM, Dickman ED, Dias JK, Lambert J. Personal digital assistants used to document compliance of bacterial vaginosis treatment. Sex Transm Dis 2004;31(8):488-491.23. 4. Ness RB, Kip KE, Hillier SL et al. A Cluster Analysis of Bacterial Vaginosis-Associated Microflora and Pelvic Inflammatory Disease. Am J Epidemiol 2005;162(6):585-590. 5. Chavoustie SE, Maribona AS, Hanna M. Bacterial Vaginosis and the Risk for Sexually Transmitted Infections. Contemp Ob Gyn 2020. Educational Supplement. 6. Thurman AR, Kimble t, Herold B et al. Bacterial Vaginosis and Subclinical Markers of Genital Tract Inflammation and Mucosal Immunity. Aids Res Hum Retrovir 2015;31(11):1139-1152. 7. Hillier SL, Nyirjesy P, Waldbaum AS, et al. Secnidazole treatment of bacterial vaginosis: a randomized controlled trial. Obstet Gynecol 2017;130(2):379-386. 8. Schwebke JR, Morgan FG Jr, Koltun W, Nyirjesy P. A phase-3, double-blind, placebo-controlled study of the effectiveness and safety of single oral doses of secnidazole 2 g for the treatment of women with bacterial vaginosis [published correction appears in Am J Obstet Gynecol 2018;219(1):110]. Am J Obstet Gynecol 2017;217(6):678.e1-678.e9. 9. Bradshaw CS, Morton AN, Hocking J, et al. High recurrence rates of bacterial vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence. J Infect Dis 2006; 193:1478–89. 10. Workowski KA, Bachmann LH, Chan PA, et al. CDC Sexually Transmitted Diseases Treatment Guidelines, 2021. MMWR Recomm Rep 2021;70(RR-04):1-192. 11. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin: Clinical Management Guidelines for Obstetricians-Gynecologists, Number 215. Obstet Gynecol 2020:135(1):e1-e17.