Solosec: First Single-Dose Oral Therapy for Bacterial Vaginosis

The first single-dose oral therapy is now available for the treatment of bacterial vaginosis (BV) in adults. Solosec (secnidazole 2g oral granules; Lupin) is a potent, next-generation, the 5-nitroimidazole antimicrobial drug that comes in a single-dose granule form intended for consumption by sprinkling on food such as yogurt or pudding. However, it should not be dissolved in any liquid. The mixture should be consumed within 30 minutes without chewing or crunching the granules.

Secnidazole is a nitroimidazole antimicrobial drug that displays selectivity against many anaerobic Gram-positive and Gram-negative bacteria and protozoa It enters the bacterial cell as an inactive prodrug where the nitro group is reduced by bacterial enzymes to radical anions. It is believed that these radical anions interfere with bacterial DNA synthesis of susceptible isolates.

The safety data reflect exposure to 589 patients, of whom 518 received a 2 g dose of SOLOSEC. SOLOSEC was evaluated in three clinical trials of patients diagnosed with bacterial vaginosis: two placebo-controlled trials (Trial 1 n=215, Trial 2 n=189) and one uncontrolled safety trial (Trial 3 n=321).

Initially, Solosec was approved by The Food and Drug Administration (FDA) 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, 67.7% vs 17.7% and in Trial 2, 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%).

There was no clinically significant drug interaction between secnidazole and the combination oral contraceptive, ethinyl estradiol plus norethindrone and can be co-administered with combination oral contraceptives (e.g., ethinyl estradiol plus norethindrone).

"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.

Bacterial vaginosis (BV) is a disease of the vagina caused by excessive growth of bacteria. Common symptoms include increased vaginal discharge that often smells like fish. The discharge is usually white or gray in color. Burning with urination may occur.