FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

Solosec (secnidazole)

Indication:

Treatment of bacterial vaginosis.

Mechanism:

Nitroimidazole derivative. 5-nitroimidazole enters the bacterial cell as an inactive prodrug, where the nitro group is reduced by bacterial enzymes to radical anions that interfere with bacterial DNA synthesis in susceptible isolates.

Dosage:

1 packet (2 grams) of granules PO once daily, without regard to timing of meals. Sprinkle granules onto applesauce, yogurt, or pudding and consume within 30 minutes without chewing or crunching the granules.

Approval:

Approval was based on 2 randomized, placebo-controlled studies that evaluated the efficacy of secnidazole in treatment of bacterial vaginosis. Efficacy was assessed by clinical outcomes evaluated 21-30 days following a single dose of secnidazole. In both trials, a statistically significant greater percentage of patients experienced clinical response (trial 1: 67.7%; trial 2: 53.3%), Nugent score cure (trial 1: 40.3%; trial 2: 43.9%), and therapeutic response tTrial 1: 40.3%; trial 2: 34.6%) at 21-30 days following a single dose of secnidazole compared with placebo.

References:

Schwebke JR, et al. 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. Am J Obstet Gynecol. 2017 Sep 1.

Bohbot JM, et al. Treatment of bacterial vaginosis: a multicenter, double-blind, double-dummy, randomised phase III study comparing secnidazole and metronidazole. Infect Dis Obstet Gynecol. 2010. Published online 2010 Sep 15.

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