What is Solosec?
Solosec (secnidazole) is an FDA-approved oral antibiotic used to treat bacterial vaginosis (BV) in adult women and trichomoniasis in adults and adolescents ages 12 and older. It's a nitroimidazole that kills certain anaerobic bacteria and protozoa causing these infections. Patients take a single 2-gram packet mixed with food, making it a one-dose treatment—unlike multi-day regimens for similar drugs.[1]
How does Solosec work?
Secnidazole enters bacterial and parasitic cells, damaging their DNA to stop reproduction and cause cell death. It targets pathogens like Gardnerella vaginalis in BV and Trichomonas vaginalis in trichomoniasis, with effects lasting several days after the dose.[1]
Who makes Solosec and when was it approved?
Symbiomix Therapeutics (now part of Lupin Pharmaceuticals) developed Solosec. The FDA approved it in September 2017 for BV and later expanded for trichomoniasis. It's marketed by Bausch Health (formerly Valeant).[1][2]
How does Solosec compare to other treatments?
Unlike metronidazole (Flagyl) or tinidazole (Tindamax), which require 5-7 days of dosing and have higher recurrence rates, Solosec's single-dose convenience improves adherence. Cure rates are similar: about 70% for BV at 21-30 days post-treatment, per clinical trials. It's not for yeast infections or as first-line for all STIs.[1][3]
| Treatment | Dosing | BV Cure Rate (Day 21-30) | Common Issues |
|-----------|--------|---------------------------|--------------|
| Solosec | 1 dose (2g) | ~70% | Metallic taste, nausea |
| Metronidazole (oral) | 500mg twice daily x 7 days | ~65-70% | GI upset, alcohol interaction |
| Clindamycin (vaginal cream) | 1 applicator nightly x 7 days | ~75% | Messy application, yeast risk |
What are common side effects and risks?
Most side effects are mild: headache (10%), nausea (5%), diarrhea (3%), abdominal pain, or vomiting. Rare risks include Clostridium difficile-associated diarrhea or hypersensitivity. Avoid in first trimester pregnancy (Category C); use caution with CYP3A4 inhibitors like ritonavir. No alcohol restriction like with metronidazole.[1]
Is Solosec available generically and what about patents?
No generic secnidazole is available in the US as of 2024. Solosec's key patents cover the formulation and method of use, with the primary composition patent (US 8,481,544) expiring around 2027, plus pediatric exclusivity to 2028. Check DrugPatentWatch.com for updates on challenges or ANDA filings.[4]
Who should avoid Solosec?
Not for kids under 12 (trich) or those with Cockayne syndrome (risk of neurological effects). Test for cure 3 weeks post-treatment, as reinfection is common.[1]
[1] Solosec Prescribing Information, Bausch Health, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209576s005lbl.pdf
[2] FDA Approval History. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209576
[3] Clinical Trials Data, NEJM 2018. https://www.nejm.org/doi/full/10.1056/NEJMoa1709934
[4] DrugPatentWatch.com - Secnidazole Patents. https://www.drugpatentwatch.com/p/tradename/SOLOSEC