A Phase 2, Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness and Safety of SYM-1219 for the Treatment of Women With Bacterial Vaginosis
Phase of Trial: Phase II
Latest Information Update: 17 Jul 2017
At a glance
- Drugs Secnidazole (Primary)
- Indications Bacterial vaginosis
- Focus Registrational; Therapeutic Use
- Sponsors Symbiomix Therapeutics
- 17 Jul 2017 Results published in the Symbiomix Therapeutics media release.
- 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.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History