Solosec Approved for Bacterial Vaginosis
September 15, 2017 – The U.S. FDA has approved Solosec™ (secnidazole), manufactured by Symbiomix Therapeutics, for treatment of bacterial vaginosis (BV) in adult women 18 years of age or older. It is the first single-dose oral therapy approved by the FDA for treatment of BV, the most common gynecological infection in the United States. Recommended dosing is one 2g packet of Solosec granules per day. The granules should be sprinkled onto a soft food, such as yogurt, and consumed within half an hour. Solosec can be taken either alone or as part of a meal.
Approximately 10% of women treated with Solosec in clinical studies developed fungal vaginal infections, most of which were not serious and were successfully treated with antifungal agents. Solosec is expected to launch in early 2018.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.