FDA approves first single dose oral secnidazole (Solosec) for Bacterial Vaginosis

The US Food and Drug Administration (FDA) approved first and only single dose oral therapy, secnidazole 2 gms (Solosec, Symbiomix Therapeutics) for treatment of women with bacterial vaginosis (BV), the most common U.S. gynecologic infection in women aged 14 to 49 years, according to the Centers for Disease Control and Prevention.

The antibiotic is manufactured by Symbiomix Therapeutics, Newark, NJ.

The single dose 2 gm secnidazole comes in the form of packaged granules, the entire contents of the packet should be sprinkled onto applesauce, yogurt or pudding and consumed once within 30 minutes without chewing or crunching the granules. It cannot be consumed by dissolving it in any liquid.

The current treatment regimen is prescribed for at least twice a day for 7 days, which has resulted in only 50% of the patient taking the full course of antibiotics. Incomplete treatment of BV leads put the patient at high risk of contracting other sexually transmitted diseases like chlamydia, gonorrhea, herpes, trichomaniasis and HIV. It also results in preterm births and low birth weight.

David L. Stern, CEO of Symbiomix, “The FDA’s approval of this first-of-its-kind treatment is an important milestone for Symbiomix and most importantly, millions of women suffering from BV. The approval of Solosec™ represents a critical moment in our efforts to bring innovative medicines to the women’s health market. Solosec is the first new oral antibiotic to treat BV in more than a decade and will provide women with a new treatment option. We look forward to making this treatment available to patients in the first quarter of 2018.”

The FDA’s approval comes in wake of successful results of two pivotal clinical trials involving a total of 333 nonpregnant women up to age 54. The patients were assessed based on 3 endpoints namely: clinical responder, therapeutic responder and Nugent score cure (Nugent score < 3).

In both the trials significant more number of patients attained clinical and therapeutic cure as compared to placebo. Adverse effects were mild or moderate and includes Vulvovaginal candidiasis, headache, nausea, dysgeusia, vomiting, abdominal pain and diarrhea. The drug label warns that Vulvovaginal candidiasis may require antifungal treatment.

The FDA designated Solosec as a Qualified Infectious Disease Product (QIDP) for the treatment of BV and granted it Fast Track designation, which made Solosec eligible for priority review and at least 10 years of U.S. market exclusivity.

The label also warns against chronic use, animal studies have demonstrated its carcinogenic potential after long use. It is also contraindicated in pregnancy and lactation.

The FDA Drug label.

New release by Symbiomix Therapeutics