A Phase 3, Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness and Safety of SYM-1219 2 Grams for the Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis

Trial Profile

A Phase 3, Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness and Safety of SYM-1219 2 Grams for the Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Mar 2017

At a glance

  • Drugs Secnidazole (Primary)
  • Indications Bacterial vaginosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Symbiomix Therapeutics
  • Most Recent Events

    • 23 Mar 2017 According to a Symbiomix Therapeutics media release, the US Food and Drug Administration has accepted for filing the company's New Drug Application (NDA) for Solosec. In accordance with the FDA's priority 6-month review designation, the agency has established a user-fee goal date under the Prescription Drug User Fee Act of September 17, 2017. The NDA was supported by a comprehensive set of non-clinical and clinical studies, including the two pivotal trials (SYM-1219-201 and SYM-1219-301).
    • 19 Jan 2017 According to a Symbiomix Therapeutics media release, company has submitted new drug application (NDA) for Solosec (secnidazole oral granules) for the treatment of bacterial vaginosis to the US Food and Drug Administration (FDA), based on data from SYM-1219-201 and SYM-1219-301 trials.
    • 26 May 2016 According to a Symbiomix Therapeutics media release, the company plans to file an NDA for secnidazole in the fourth quarter of 2016.
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