Symbiomix Therapeutics announced the U.S. Food and Drug Administration (FDA) has approved its lead product Solosec™ (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women.

Following approval on September 15, 2017, Solosec is anticipated to be commercially available in early 2018.

Solosec™ has been designated as a Qualified Infectious Disease Product (QIDP) by the U.S. Food and Drug Administration (FDA) for the treatment of BV. QIDP designation creates incentives for the development of new drugs intended to treat serious or life threatening infections and makes Solosec™ eligible for certain benefits including at least 10 years of market exclusivity.

The FDA approval was supported by a comprehensive set of studies, including two pivotal trials in BV and an open label safety study, which found efficacy for single-dose secnidazole 2g. All treatment-emergent adverse events were mild or moderate in intensity; no serious adverse events were reported, and no patients discontinued treatment due to adverse events. [6,7]

Indication

SOLOSECTM (secnidazole) 2g oral granules is a 5-nitroimidazole antimicrobial agent indicated for the treatment of bacterial vaginosis in adult women.

Important Safety Information

SOLOSEC is contraindicated in patients with a history of hypersensitivity to secnidazole, other ingredients of the formulation, or other nitroimidazole derivatives.

Vulvo-vaginal candidiasis may develop with SOLOSEC and require treatment with an antifungal agent.

Potential risk of carcinogenicity in patients taking single-dose of SOLOSEC to treat bacterial vaginosis is unclear. Chronic use should be avoided.

SOLOSEC may pass into breast milk. Patients should discontinue breastfeeding for 96 hours after administration of SOLOSEC.

SOLOSEC is a single-dose therapy for oral use. The entire contents of SOLOSEC packet should be sprinkled onto applesauce, yogurt or pudding and consumed once within 30 minutes without chewing or crunching the granules. SOLOSEC is not intended to be dissolved in any liquid.

In clinical studies, the most common adverse events occurring in (≥2%) of patients receiving SOLOSEC 2g oral granules were vulvovaginal candidiasis (9.6%), headache (3.6%),nausea (3.6%), dysgeusia (3.4%), vomiting (2.5%), diarrhea (2.5%), abdominal pain (2.0%), andvulvovaginal pruritus (2.0%).