Lupin Pharmaceuticals, Inc., the U.S. based wholly-owned subsidiary of Lupin Limited (Lupin), announced today that the U.S. Food and Drug Administration (FDA) has accepted their supplemental New Drug Application (sNDA) for Solosec® (secnidazole) for the treatment of trichomoniasis in adults and adolescents.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of June 30, 2021. Trichomoniasis vaginalis is the most common non-viral, curable sexually transmitted infection (STI) in the U.S., affecting an estimated 3 to 5 million people.1 Solosec® 2 g oral granules is currently FDA-approved to treat bacterial vaginosis (BV) in adult women.
“The FDA acceptance of our application for Solosec® to treat trichomoniasis is an important milestone for our company and for patients who are in need of new options for the treatment of trichomoniasis,” said Jon Stelzmiller, President – Specialty, Lupin Pharmaceuticals, Inc. “We look forward to working with the FDA during their review of our file for this new indication.”
If approved for trichomoniasis, Solosec® could be the only single-dose oral prescription treatment for both BV and trichomoniasis.
The Solosec sNDA is based, in part, on trial results that showed a clinically and statistically significant response rate, or microbiological cure, in patients treated with Solosec® as compared to placebo (p<0.001). In the Per-Protocol population, the cure rate was 94.9% (56/59) for Solosec® versus 1.7% (1/60) for placebo (p<0.001). Solosec® was generally well-tolerated.
The most commonly reported adverse events were vulvovaginal candidiasis (2.7%) and nausea (2.7%). No serious adverse events were observed in the trial. The data were presented at the 2020 Infectious Diseases Society for Obstetrics & Gynecology (IDSOG) Virtual Annual Meeting.
Trichomoniasis is the most common non-viral sexually transmitted infection (STI) in the U.S., and is caused by a protozoan parasite called Trichomonas Vaginalis (T. vaginalis).2 An estimated 3 to 5 million people have the infection,1 with African American women having a nearly ten times higher risk of being affected compared with non-Hispanic white women.
Trichomoniasis is four-to-five times more prevalent in women compared to men.3 Signs and symptoms in women can include itching, burning, redness or soreness of the genitals, discomfort with urination and vaginal discharge.2 However, most infected persons (70%-85%) have minimal or no symptoms, and untreated infections might last for months to a year.2,4,8 Trichomoniasis is associated with a two- to three-fold increased risk of HIV infection,5,6 as well as adverse reproductive health outcomes, including infertility and preterm birth.
Solosec (secnidazole) 2g oral granules is the first and only single-dose oral prescription treatment option to treat bacterial vaginosis (BV), a common vaginal infection, in adult women.9 Solosec® is easy to take and one oral dose contains a full course of treatment. Women who are prescribed Solosec® may sprinkle the entire packet of granules onto applesauce, yogurt, or pudding and eat the entire mixture, without chewing the granules, within 30 minutes. One dose delivers a complete treatment and Solosec® can be taken at any time of the day, without regard to the timing of meals.9 There is no need to avoid any foods or drinks, including alcohol, with Solosec®. Laboratory studies show Solosec® does not inhibit the enzyme that processes alcohol in the body.9 Because Solosec® is taken in one oral dose, it may be preferred by women who wish to avoid a multi-day treatment regimen.
Source: Company Press Release