FDA approves Solosec oral granules for treatment of bacterial vaginosis
Symbiomix Therapeutics announced today that the FDA has approved Solosec 2-g oral granules as the first single-dose oral treatment option for adult women with bacterial vaginosis, the most common gynecologic infection in the U.S., according to a press release.
Solosec (secnidazole, Symbiomix) — a next-generation, 5-nitroimidazole antimicrobial agent — is the first oral antibiotic to be approved for bacterial vaginosis (BV) in more than a decade, according to David L. Stern, CEO of Symbiomix.
“We look forward to making this treatment available to patients in the first quarter of 2018,” he said in the release.
The FDA approval is based on data from a comprehensive set of studies, including two randomized, double blind trials in which 144 nonpregnant women aged 19 to 54 years (Trial 1) and 189 nonpregnant women aged 18 to 54 years (Trial 2) were randomly assigned to receive secnidazole 2-g oral granules or placebo. In the modified intent-to-treat population, 67.7% of patients in Trial 1 and 53.3% in Trial 2 who received secnidazole experienced a clinical response 21 to 30 days after the first dose vs. 17.7% in Trial 1 and 19.3% in Trial 2 who received placebo (P < .001). Similarly, 40.3% of patients in Trial 1 and 34.6% of patients in Trial 2 who received secnidazole achieved a therapeutic response vs. 6.5% in Trial 1 and 3.5% in Trial 2 who received placebo (P < .001).
All treatment-emergent adverse events were mild or moderate in severity, the release said. The most common adverse events in clinical studies included vulvovaginal candidiasis (9.6%), headache (3.6%), nausea (3.6%), dysgeusia (3.4%), vomiting (2.5%), diarrhea (2.5%), abdominal pain (2%) and vulvovaginal pruritus (2%). No patients discontinued treatment due to adverse events.
If left untreated, BV, which affects 21 million aged 14 to 49 years each year in the U.S., can increase the risk for sexually transmitted diseases, preterm birth and low birth weight, according to the release. The most commonly prescribed oral regimen for BV requires twice-daily dosing for 7 days. However, evidence has shown that adherence to the current leading regimen is approximately 50%, the release said.
“The approval of Solosec finally gives women the option of a single, well-tolerated, oral dose treatment for BV, a common infection [that] can have many health consequences,” Paul Nyirjesy, MD, professor of obstetrics and gynecology at Drexel University College of Medicine in Philadelphia, said in the release. “A single dose regimen may improve adherence and the likelihood of a successful cure.”
Symbiomix Therapeutics. FDA Approves Symbiomix Therapeutics’ Solosec (secnidazole) Oral Granules for the Treatment of Bacterial Vaginosis in Adult Women. 2017. https://symbiomix.com/fda-approves-symbiomix-therapeutics-solosec-secnidazole-oral-granules-treatment-bacterial-vaginosis-adult-women/. Accessed September 18, 2017.
Symbiomix Therapeutics. Highlights of Prescribing Information. 2017. http://www.solosec.com/pdf/symbiomix-full-prescribing-information.pdf. Accessed September 18, 2017.
Disclosures: Nyirjesy is an investigator in clinical trials for secnidazole. Stern is an employee of Symbiomix.