Solosec (secnidazole 2g oral granules; Lupin) is now available for the treatment of bacterial vaginosis (BV) in adults. The treatment is the first single-dose oral therapy for this indication.
Solosec is a potent, next-generation, 5-nitroimidazole antimicrobial drug that comes in a single-dose granule form and is intended for consumption by sprinkling on food such as yogurt or pudding; it should not be dissolved in any liquid. The mixture should be consumed within 30 minutes without chewing or crunching the granules.
The Food and Drug Administration (FDA) initially approved Solosec in September 2017 based on 2 pivotal trials in BV and an open-label safety study. In both major trials, a statistically significant greater percentage of patients experienced clinical response with Solosec vs those treated with placebo at 21 to 30 days following a single dose (Trial 1 [n=144]: 67.7% vs 17.7%; Trial 2 [n=189]: 53.3% vs 19.3%).
In addition, more patients treated with Solosec had a greater Nugent score cure (Trial 1: 40.3% vs 6.5%; Trial 2: 43.9% vs 5.3%) and more were considered therapeutic responders (Trial 1: 40.3% vs 6.5%; Trial 2: 34.6% vs 3.5%).
“There is a clear need for an effective, single-dose oral treatment option that normalizes BV symptoms without the use of creams or week-long regimens to improve adherence,” said Nick Hart, President – Specialty, Lupin Pharmaceuticals, Inc.
The FDA designated Solosec as a Qualified Infectious Disease Product (QIDP) for the treatment of BV making it eligible for ≥10 years of US market exclusivity.
Solosec is supplied as oral granules in single 2g unit-of-use, child-resistant packets.
For more information call (844) 765-6732 or visit Solosec.com.