"Secnidazole"

Secnidazole (Solosec) - To treat bacterial vaginosis Solosec (secnidazole) Oral Granules * Skip to main page content * Skip to search * Skip to topics menu * Skip to common linksHHS U.S. Department of Health and Human Services U.S. Food and Drug Administration * Follow FDA * En EspañolSearch FDASubmit search * Popular Content * Home * Food * Drugs * Medical Devices * Radiation-Emitting Products * Vaccines, Blood & Biologics * Animal & Veterinary * Cosmetics * Tobacco Products * Home * Drugs * Drug Approvals and Databases * Drugs@FDASolosec (secnidazole) Oral Granules * Share * Tweet * Linkedin * Pin it * More sharing options * Linkedin * Pin it * Email * Print SolosecCompany: Symbiomix Therapeutics, LLCApplication No.: 209363Approval Date: 09/15/2017Persons

Efficacy of single-dose oral secnidazole for the treatment of trichomoniasis in women co-infected with trichomoniasis and bacterial vaginosis: a post hoc subgroup analysis of phase 3 clinical trial data. Bacterial vaginosis (BV) and trichomoniasis are the most common causes of vaginitis. Both infections are associated with increased risk of acquisition and transmission of HIV and other sexually transmitted infections as well as adverse reproductive health outcomes. Co-infection is common, with rates ranging from 60% to 80%. We evaluated the efficacy of single-dose oral secnidazole 2 g for the treatment of trichomoniasis in a subgroup of women co-infected with BV and trichomoniasis. Post hoc analysis of data from a phase 3 randomised, double-blind, placebo-controlled, delayed-treatment study. 10

Efficacy and Safety of Single Oral Dosing of Secnidazole for Trichomoniasis in Women: Results of a Phase 3, Randomized, Double-Blind, Placebo-Controlled, Delayed-Treatment Study. Trichomonas vaginalis is the most prevalent nonviral sexually transmitted infection. We evaluated the efficacy and safety of secnidazole vs placebo in women with trichomoniasis. Women with trichomoniasis, confirmed by a positive T. vaginalis culture, were randomized to single-dose oral secnidazole 2 g or placebo. The primary endpoint was microbiological test of cure (TOC) by culture 6-12 days after dosing. At the TOC visit, participants were given the opposite treatment. They were followed for resolution of infection afterward and offered treatment at subsequent visits, if needed. Fifty patients per group (N = 100

Secnidazole An official website of the United States government Here's how you know Log inAccess keysNCBI HomepageMyNCBI HomepageMain ContentMain NavigationBookshelfSearch databaseBooksAll DatabasesAssemblyBiocollectionsBioProjectBioSampleBooksClinVarConserved DomainsdbGaPdbVarGeneGenomeGEO DataSetsGEO ProfilesGTRHomoloGeneIdentical Protein GroupsMedGenMeSHNLM and EffectsSummary of Use during LactationNo information is available on the clinical use of secnidazole during breastfeeding and no studies have evaluated adverse effects of secnidazole on the infant during breastfeeding, but presumably they are similar to those of the closely related drug, metronidazole, such as increased risk of oral and rectal Candida infections.As with metronidazole, concern has been raised

An Integrated Efficacy and Safety Analysis of Single-Dose Secnidazole 2 g in the Treatment of Bacterial Vaginosis. Bacterial vaginosis (BV) is the most common gynecologic infection in women aged 14 to 49 years. Currently recommended treatments require extended dosing and are thus associated with poor adherence. A single-dose oral granule formulation of secnidazole 2 g (SOLOSEC™ [secnidazole of secnidazole 2 g. This is an integrated analysis of efficacy and safety results from these studies, pivotal study 1 and pivotal study 2. By combining the results of the two studies, relevant information is presented especially when considering the effect of secnidazole on patients with recurrent episodes of BV and the difference in effect on patients of black race. Single-dose secnidazole 2 g

Secnidazole Treatment of Bacterial Vaginosis: A Randomized Controlled Trial To evaluate secnidazole as a single oral dose treatment for bacterial vaginosis in a phase 2 randomized, double-blind, placebo-controlled study. In a phase 2, randomized, double-blind, dose-ranging, placebo-controlled study, women with bacterial vaginosis who met all Amsel criteria (discharge; pH 4.7 or greater; 20 % or greater clue cells; positive whiff test) were randomized one to one to one at 24 U.S. centers to 1 or 2 g secnidazole compared with placebo. The primary endpoint was clinical cure (normalization of discharge, amine odor, and clue cells) 21-30 days after treatment. Secondary endpoints included microbiologic cure, defined as a Nugent score of 0-3, and therapeutic cure, defined as meeting criteria for both

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 A novel single oral dose granule formulation of secnidazole 2 g, a 5-nitroimidazole with a longer half-life (∼17 hours) than metronidazole (∼8 hours), is being developed to treat bacterial vaginosis. We sought to evaluate the effectiveness and safety of single-dose secnidazole 2 g compared to placebo for the treatment of women with bacterial vaginosis. In all, 189 women with bacterial vaginosis were randomized 2:1 to receive a single oral dose of secnidazole 2 g (N = 125) or matched placebo (N = 64) at 21 centers in the United States. The primary endpoint was the proportion of clinical outcome responders, defined as those with: (1

Susceptibility of clinical isolates of Trichomonas vaginalis to metronidazole and secnidazole-an in vitro study. Nitroimidazoles (metronidazole [MTZ] and tinidazole [TNZ]) are the only drugs recommended for treatment of infections. MTZ resistance occurs in 4% to 10% of cases of vaginal trichomoniasis (R. D. Kirkcaldy et al., Emerg Infect Dis 18:939-943, 2012; J. R. Schwebke and F . J. Barrientes, Antimicrob Agents Chemother 50:4209-4210, 2006) and TNZ resistance in 1% of cases (J. R. Schwebke and F. J. Barrientes, Antimicrob Agents Chemother 50:4209-4210, 2006). Emerging nitroimidazole-resistant trichomoniasis is concerning, because few alternatives to standard therapy exist. We assessed the prevalence of aerobic MTZ and secnidazole resistance among isolates collected

The efficacy of proanthocyanidins and secnidazole in the treatment of chronic periodontitis after scaling and root planing therapy. The aim of this study is to evaluate the clinical and microbiological effect of the systemic antibiotic therapy of proanthocyanidins and secnidazole on periodontitis. Seventy-five subjects with chronic periodontitis were randomly divided into two treatment groups (secnidazole or proanthocyanidins) and one placebo control group (25 cases each). Plaque index (PI), gingival index (GI), gingival bleeding index (BI), probing pocket depth (PPD), and clinical attachment level (CAL) were carried out at baseline, post-treatment and 3 months after treatment. Microbial analysis was performed at baseline and post-treatment. The results show that the two treatment groups had

Two Phase 1, Open‐Label, Single‐Dose, Randomized, Crossover Studies to Assess the Pharmacokinetics, Safety, and Tolerability of Orally Administered Granules of Secnidazole (2 g) in Healthy Female Volunteers Under Different Administration Conditions Bacterial vaginosis (BV) is the most common vaginal infection in reproductive-age women and a significant risk factor for sexually transmitted diseases and pregnancy complications. Standard 5- to 7-day antimicrobial treatments for BV are associated with high rates of recurrence and adverse events. SYM-1219 is a novel granule formulation containing 2 g of secnidazole, developed as an oral, single-dose BV treatment. Two phase 1, open-label, single-center, randomized, crossover trials (studies 102 and 103) assessed the pharmacokinetics and safety

Susceptibility of bacterial vaginosis (BV)-associated bacteria to secnidazole compared to metronidazole, tinidazole and clindamycin Secnidazole, a 5-nitroimidazole with a longer half-life, is structurally related to metronidazole and tinidazole. For treatment of bacterial vaginosis (BV), secnidazole is a suitable single-dose oral drug having a longer serum half-life than metronidazole . The objective of this study was to evaluate the antimicrobial susceptibility of vaginal isolates of facultative and anaerobic bacteria to secnidazole, metronidazole, tinidazole and clindamycin. A total of 605 unique BV-related bacteria and 108 isolates of lactobacilli recovered from the human vagina of US women during the years 2009-2015 were tested for antimicrobial susceptibility by the agar dilution CLSI

Thorough QT/QTc Evaluation of the Cardiac Safety of Secnidazole at Therapeutic and Supratherapeutic Doses in Healthy Individuals SYM-1219, a novel oral granule formulation of secnidazole, is under development as single-dose treatment for bacterial vaginosis. This 4-way, randomized, crossover study evaluated the effects of SYM-1219 on electrocardiographic (ECG) parameters in 52 healthy subjects . Subjects were administered single doses of SYM-1219, 2 g (proposed therapeutic dose), 6 g (supratherapeutic dose), placebo, and moxifloxacin (positive control). Serial digital 12-lead ECGs were recorded pre- and postdose; blood samples were taken to determine plasma secnidazole concentrations. A high-precision QT technique measured ECGs. The primary end point was change from baseline QTcF (∆QTcF); data

Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole This is a multi-centered, randomized, open-label, parallel, phase IV clinical trial comparing the effectiveness and cost-effectiveness of oral multi-dose metronidazole (MTZ) and oral single-dose secnidazole (SEC) for the treatment of Trichomonas vaginalis in both women and men . This is a multi-centered, randomized, open-label, parallel, phase IV clinical trial comparing the effectiveness and cost-effectiveness of oral multi-dose metronidazole (MTZ) and oral single-dose secnidazole (SEC) for the treatment of Trichomonas vaginalis in both women and men. Our goal is to refine T. vaginalis treatment for women and men by examining the effectiveness (Aim 1) and cost-effectiveness (Aim 2

Lack of a Pharmacokinetic Interaction Between SYM-1219 Granules Containing 2 Grams of Secnidazole and a Combined Oral Contraceptive in a Phase 1, Randomized, Open-Label Study in Healthy Female Volunteers. Bacterial vaginosis (BV) is a serious infection that is the most common vaginal infection in women of childbearing potential. SYM-1219 is a novel, granule formulation containing 2 g of secnidazole that is being developed as a single, oral dose to treat women with BV. Because many of the women diagnosed with BV use hormonal contraception, the effect of SYM-1219 on the pharmacokinetics (PK) of commonly prescribed oral contraceptive drugs, ethinyl estradiol (EE2), and norethindrone (NET) was evaluated. This two-period, randomized, open-label study examined effects in 54 healthy female

Safety and Effectiveness of secnidazole (Solosec) in Trichomoniasis: A Systematic Review and Meta-Analysis of randomized controlled trials. PROSPEROInternational prospective register of systematic reviews Print | PDFSafety and Effectiveness of secnidazole (Solosec) in Trichomoniasis: A Systematic Review and Meta-Analysis of randomized controlled trials.Zheng Xue Hai, Tan Ying Feng, Xu Jun Yu registration. Further detail is provided here.CitationZheng Xue Hai, Tan Ying Feng, Xu Jun Yu, He Yu Xia, Wang Fei Fei, Zhao Pei xiong. Safety and Effectiveness of secnidazole (Solosec) in Trichomoniasis: A Systematic Review and Meta-Analysis of randomized controlled trials.. PROSPERO 2023 CRD42023470115 Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023470115Review

Suppressive Antibacterial Therapy With Once-Weekly Secnidazole Granules to Prevent Recurrent Bacterial Vaginosis; A Pilot Study The purpose of this study is to test the effectiveness Secnidazole to treat recurrent BV. Secnidazole is approved for one-time use in acute BV. In this study, the drug will be used for recurrent BV, and given weekly for 18 weeks. A single-center prospective pilot study with once-weekly oral secnidazole granule treatment of acute condition for two-weeks followed by prophylactic treatment of asymptomatic responders with once-weekly secnidazole for 16 weeks, followed by no therapy for 12 weeks. The final follow-up evaluation is at week 28.Eligible women with a current symptomatic bacterial vaginosis infection (> or = 3 Amsel criteria) and a history of at least 2 previous

twice daily for 7 days.Where adherence to multiple doses is a serious concern, WHO suggests one of the following options:• metronidazole 2 g orally as a single dose; or• tinidazole 2 g orally as a single dose (except during pregnancy).Remarks:• Secnidazole 2 g orally as a single dose (except during pregnancy) or ornidazole 1.5 g orally as a single dose (except during pregnancy) could be used is not available, adherence to multiple doses is a serious concern, or if vaginal creams are preferred, WHO suggests one of the following options:• metronidazole 0.75% gel intravaginally for 7 days; • tinidazole 2 g orally as a single dose (except during pregnancy);• clindamycin 300 mg twice daily for 7 days; • clindamycin 2% gel (5 g) intravaginally once daily for 7 days; or• secnidazole 2 g orally as a single

of the disease, reduces post infectiouscomplications, and limits onward transmission.61–63Tinidazole and metronidazole are the most effectiveagents to treat giardiasis. Other 5-nitroimidazole drugssuch as secnidazole or ornidazole have milder side effectsthan metronidazole, but are unlicensed in the UK andharder to obtain.62,63,67Nitroimidazole monotherapy of-fers 45–95% cure, however cases refractory

giardiasis. Other 5-nitroimidazole drugssuch as secnidazole or ornidazole have milder side effectsthan metronidazole, but are unlicensed in the UK andharder to obtain.62,63,67Nitroimidazole monotherapy of-fers 45–95% cure, however cases refractory to treatmentare increasing.62,67,68(Table 2) Refractory Giardiasis isseen in up to 70% of patients with travel associated di-arrhoea returning from the Indian