Lupin Announces FDA Filing Acceptance of Supplemental New Drug Application for Solosec® (secnidazole) for the Treatment of Trichomoniasis

MUMBAI, India and BALTIMORE, Nov. 16, 2020 /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^® (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.  

About Trichomoniasis

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.³ 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.⁷ Up to 53% of women with HIV infection also have T. vaginalis, which is associated with a significantly increased risk of contracting pelvic inflammatory disease.⁸ Routine screening of asymptomatic women with HIV infection for T. vaginalis is recommended because of the adverse events associated with asymptomatic trichomoniasis and HIV infection.⁸ Patients 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

About Solosec^®

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.^9,10 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.¹¹

INDICATION

Solosec^® (secnidazole) 2 g oral granules is a 5-nitroimidazole antimicrobial agent indicated for the treatment of BV in adult women.

DOSAGE AND ADMINISTRATION

Solosec^® is a single-dose therapy for oral use. The entire contents of Solosec^® packet should be sprinkled onto applesauce, yogurt or pudding and consumed once within 30 minutes without chewing or crunching the granules. Solosec^® is not intended to be dissolved in any liquid.

IMPORTANT SAFETY INFORMATION

• Solosec^® is contraindicated in patients with a history of hypersensitivity to secnidazole, other ingredients of the formulation or other nitroimidazole derivatives.
• Vulvo-vaginal candidiasis may develop with Solosec^® and require treatment with an antifungal agent.
• Potential risk of carcinogenicity is unknown and has not been studied. Carcinogenicity has been seen in rodents chronically treated with nitroimidazole derivatives, which are structurally related to secnidazole. Chronic use should be avoided.
• Breastfeeding is not recommended. Patients should discontinue breastfeeding for 96 hours after administration of Solosec^®.
• Most common adverse reactions observed in clinical trials (incidence ≥ 2%) were vulvovaginal candidiasis, headache, nausea, dysgeusia, vomiting, diarrhea, abdominal pain and vulvovaginal pruritus.

To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-844-SOLOSEC (1-844-765-6732) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see accompanying full Prescribing Information.

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Solosec^® is a registered trademark owned by Lupin Inc.

About Lupin Pharmaceuticals, Inc.

Lupin Pharmaceuticals, Inc. is the U.S. based wholly-owned subsidiary of Lupin Limited and is the 3rd largest pharmaceutical company in the U.S. based on total prescriptions. Together, all Lupin-owned entities combine to make up the 8th largest generic pharmaceutical company in the world by revenue size. Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality medications across many treatment areas. Lupin Pharmaceuticals, Inc.'s branded pharmaceuticals division, is the provider of products designed to help prevent and manage women's health conditions with serious health consequences.

Please visit www.lupin.com/US/ for more information.

© 2020 Lupin Pharmaceuticals, Inc. All rights reserved.

Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:

This release contains forward-looking statements that involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Many of these risks, uncertainties and other factors include failure of clinical trials, delays in development, registration and product approvals, changes in the competitive environment, increased government control over pricing, fluctuations in the capital and foreign exchange markets and the ability to maintain patent and other intellectual property protection. The information presented in this release represents management's expectations and intentions as of this date. Lupin expressly disavows any obligation to update the information presented in this release.

For further information or queries please contact -

Caren Begun
Green Room Communications
Email: [email protected]
Tel: +1 201 396 8551

References:

¹ American College of Obstetricians and Gynecologists. Vaginitis in Nonpregnant Patients. ACOG Practice Bulletin No. 215. Obstet Gynecol 2020;135(1):e1-17.

² Centers for Disease Control and Prevention. Trichomoniasis - CDC Fact Sheet. Available at: https://www.cdc.gov/std/trichomonas/stdfact-trichomoniasis.htm. Accessed November 12, 2020.

³ Flagg EW, Meites E, Phillips C, Papp J, Torrone EA. Prevalence of Trichomonas vaginalis Among Civilian, Noninstitutionalized Male and Female Population Aged 14 to 59 Years: United States, 2013 to 2016. Sex Transm Dis. 2019;46(10):e93–e96. doi:10.1097/OLQ.0000000000001013.

⁴ Daugherty M. Prevalence of Trichomonas vaginalis Infection Among US Males, 2013-2016. Clinical Infectious Diseases. 2019 Feb.; 68(3): 460–46.

⁵ McClelland, RS. Infection with Trichomonas vaginalis increases the risk of HIV-1 acquisition. Journal of Infectious Diseases. 2007 Mar 1;195(5):698-702.

⁶ Van Der Pol, B. Trichomonas vaginalis infection and human immunodeficiency virus acquisition in African women. Journal of Infectious Diseases. 2008 Feb;197(4):548-54.

⁷ Sobel JD, Mitchell C. Trichomoniasis. UpToDate. Available at: https://www.uptodate.com/contents/trichomoniasis. Accessed September 10, 2020.

⁸ Centers for Disease Control and Infection. 2015 Sexually Transmitted Diseases Treatment Guidelines. Trichomoniasis. Available at: https://www.cdc.gov/std/tg2015/trichomoniasis.htm. Accessed November 12, 2020.

⁹ SOLOSEC [prescribing information]. Baltimore, MD: Lupin Pharmaceuticals, Inc; 2017.

¹⁰ Data on File, Physician Research. Advantage Healthcare, Inc. Prepared December 23, 2014

¹¹ Broumas AG, Basara LA. Potential patient preference for 3-day treatment of bacterial vaginosis: responses to new suppository form of clindamycin. Adv Ther. 2000;17(3):159-166.

SOURCE Lupin Pharmaceuticals, Inc.