{"id":381314,"date":"2020-11-16T01:04:40","date_gmt":"2020-11-16T06:04:40","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=381314"},"modified":"2020-11-16T01:04:40","modified_gmt":"2020-11-16T06:04:40","slug":"lupin-announces-fda-filing-acceptance-of-supplemental-new-drug-application-for-solosec-secnidazole-for-the-treatment-of-trichomoniasis","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/lupin-announces-fda-filing-acceptance-of-supplemental-new-drug-application-for-solosec-secnidazole-for-the-treatment-of-trichomoniasis\/","title":{"rendered":"Lupin Announces FDA Filing Acceptance of Supplemental New Drug Application for Solosec\u00ae (secnidazole) for the Treatment of Trichomoniasis"},"content":{"rendered":"
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PR Newswire<\/p>\n<\/p><\/div>\n

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\n MUMBAI, India<\/span> and BALTIMORE<\/span>, Nov. 16, 2020<\/span> \/PRNewswire\/ — 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\u00ae<\/sup> (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<\/span>. 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<\/sup> Solosec\u00ae<\/sup> 2 g oral granules is currently FDA-approved to treat bacterial vaginosis (BV) in adult women.<\/p>\n

\n \"lupin_pharmaceuticals_Logo\"\n <\/div>\n

“The FDA acceptance of our application for Solosec\u00ae<\/sup> 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<\/span>,<\/b>President \u2013 Specialty, Lupin Pharmaceuticals, Inc<\/b>. “We look forward to working with the FDA during their review of our file for this new indication.”\u00a0 <\/p>\n

If approved for trichomoniasis, Solosec\u00ae<\/sup> could be the only single-dose oral prescription treatment for both BV and trichomoniasis.<\/p>\n

The Solosec\u00ae<\/sup> 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\u00ae<\/sup> as compared to placebo (p<0.001). In the Per-Protocol population, the cure rate was 94.9% (56\/59) for Solosec\u00ae <\/sup>versus 1.7% (1\/60) for placebo (p<0.001). Solosec\u00ae<\/sup> 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. \u00a0<\/p>\n

\n About Trichomoniasis<\/b>\n <\/p>\n

Trichomoniasis\u00a0is 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<\/sup> An estimated 3 to 5 million people have the infection,1\u00a0<\/sup>with African American women having a nearly ten times higher risk of being affected compared with non-Hispanic white women.3<\/sup> Trichomoniasis is four-to-five times more prevalent in women compared to men.3<\/sup>\u00a0Signs and symptoms in women can include itching, burning, redness or soreness of the genitals, discomfort with urination and vaginal discharge.2<\/sup>\u00a0However, most infected persons (70%-85%) have minimal or no symptoms, and untreated infections might last for months to a year.2,4,8<\/sup>\u00a0Trichomoniasis is associated with a two- to three-fold increased risk of HIV infection,5,6<\/sup> as well as adverse reproductive health outcomes, including infertility and preterm birth.7<\/sup> Up to 53% of women with HIV infection also have\u00a0T. vaginalis, which is associated with a significantly increased risk of contracting pelvic inflammatory disease.8<\/sup> Routine screening of asymptomatic women with HIV infection for T. vaginalis<\/i> is recommended because of the adverse events associated with asymptomatic trichomoniasis and HIV infection.8<\/sup>\u00a0Patients receiving care in high-prevalence settings (e.g., sexually transmitted disease clinics) and asymptomatic patients at high risk for infection (e.g., persons with multiple sex partners, history of sexually transmitted diseases\/infections) may also be considered for screening.8<\/sup><\/p>\n

\n About Solosec\u00ae<\/sup><\/b>\n <\/p>\n

Solosec\u00ae<\/sup> (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<\/sup><\/sup> Solosec\u00ae<\/sup>\u00a0is easy to take and one oral dose contains a full course of treatment.9,10<\/sup> Women who are prescribed Solosec\u00ae<\/sup>\u00a0may 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\u00ae<\/sup>\u00a0can be taken at any time of the day, without regard to the timing of meals.9\u00a0<\/sup>There is no need to avoid any foods or drinks, including alcohol, with Solosec\u00ae<\/sup>. Laboratory studies show Solosec\u00ae<\/sup>\u00a0does not inhibit the enzyme that processes alcohol in the body.9<\/sup>\u00a0Because Solosec\u00ae<\/sup>\u00a0is taken in one oral dose, it may be preferred by women who wish to avoid a multi-day treatment regimen.11<\/sup><\/p>\n

\n INDICATION<\/b>\n <\/p>\n

Solosec\u00ae<\/sup> (secnidazole) 2 g oral granules is a 5-nitroimidazole antimicrobial agent indicated\u00a0for the treatment of BV in adult women.<\/p>\n

\n DOSAGE AND ADMINISTRATION<\/b>\n <\/p>\n

Solosec\u00ae<\/sup> is a single-dose therapy for oral use. The entire contents of Solosec\u00ae<\/sup>\u00a0packet should be sprinkled onto applesauce, yogurt or pudding and consumed once within 30 minutes without chewing or crunching the granules. Solosec\u00ae<\/sup> is not intended to be dissolved in any liquid.<\/p>\n

\n IMPORTANT SAFETY INFORMATION<\/b>\n <\/p>\n