Solosec™ (secnidazole) 2g Oral Granules Now Available in U.S. Pharmacies

First and only single-dose oral therapy for bacterial vaginosis – the most common vaginal infection – approved by the U.S. FDA in 2017

BALTIMORE--(BUSINESS WIRE)--Lupin Pharmaceuticals Inc., the U.S. wholly owned subsidiary of Lupin Limited, announced today that Solosec™ (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women is now available to patients across the United States. Solosec™, the first new oral antibiotic to treat BV in more than a decade, is the only single 2g oral dose therapy for the most common vaginal infection in the U.S. among women of childbearing age. This next-generation treatment is designed to deliver a full course of therapy in just one packet. [1,2]

BV affects 21 million women ages 14 to 49 annually. However, women of any age can get BV, even if they have never had sex. [3] Common signs and symptoms associated with BV include unusual vaginal discharge that can be white or gray; watery; or have a strong fish-like odor. Although many healthcare professionals and patients do not consider BV to be very serious, if left untreated, BV can have more severe consequences with increased risk of contracting sexually transmitted diseases, including chlamydia, trichomaniasis, gonorrhea, herpes and HIV, increase the risk of pelvic inflammatory disease (PID), which may affect fertility, or can lead to pre-term birth and low birth weight. [4,5,6]

New, single oral-dose Solosec™ was designed to be a simpler solution for patients with BV. [1] Many women have expressed frustration and dissatisfaction with current treatments, which require that they choose between multiple days of pills or messy creams, abstain from drinking alcohol, and use a backup form of birth control [7,8] – all of which make completing treatment a challenge [2,5]. In fact, studies reveal that the longer and more complex a drug regimen is, the more it may lead to poor adherence and treatment failure. [9] It only takes one packet of Solosec™ to complete treatment [1] and the single dose stays in the body and continues to treat BV for four days without an alcohol restriction: in vitro drug alcohol studies show Solosec™ does not inhibit the enzyme that metabolizes alcohol. [1]

“With more than four million women treated for BV in the U.S. annually, and only 50 percent completing 5- to 7-day treatments, there is a clear need for an effective, single-dose oral treatment option that normalizes BV symptoms without the use of creams or week-long regimens to improve adherence,” said Nick Hart, President - Specialty, Lupin Pharmaceuticals, Inc. “We are proud that Lupin has been at the forefront of advancing safe and affordable healthcare for women globally for decades, and we are committed to helping prevent and manage women’s health conditions with serious consequences, including BV.”

The FDA approval of Solosec™ was supported by a comprehensive set of studies, including two pivotal trials in BV and an open label safety study, which found efficacy for single-dose secnidazole 2g. Across both studies, Solosec™ was generally well tolerated with a low incidence of side effects. [9,11] 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 at least 10 years of U.S. market exclusivity.

Lupin Pharmaceuticals provides a cost savings program to help ensure that appropriate patients who are prescribed Solosec™ have access through the Solosec™ Savings Program where eligible patients will pay as little as $25 for treatment.

Indication

SOLOSEC™ (secnidazole) 2g oral granules is a 5-nitroimidazole antimicrobial agent indicated for the treatment of bacterial vaginosis in adult women.

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 in patients taking single-dose of SOLOSEC to treat bacterial vaginosis is unclear. Chronic use should be avoided.
• SOLOSEC may pass into breast milk. Patients should discontinue breastfeeding for 96 hours after administration of SOLOSEC.
• 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.
• In clinical studies, the most common adverse events occurring in (≥2%) of patients receiving SOLOSEC 2g oral granules were vulvovaginal candidiasis (9.6%), headache (3.6%), nausea (3.6%), dysgeusia (3.4%), vomiting (2.5%), diarrhea (2.5%), abdominal pain (2.0%), and vulvovaginal pruritus (2.0%).

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 click here for full Prescribing Information.

About Solosec™

Solosec™ (secnidazole) 2g oral granules is a potent, next-generation, 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties that enable delivery in a single dose for bacterial vaginosis (BV), the most common gynecologic infection. Solosec™ is the first and only single-dose oral therapy approved by the U.S. Food and Drug Administration (FDA) for BV in adult women. Solosec™ has been shown to be efficacious and well tolerated in clinical trials for the treatment of BV. [1,2] Additional information on Solosec™ and BV can be found at www.Solosec.com, along with a step-by-step video on how to complete the treatment.

About Lupin Pharmaceuticals, Inc.

Lupin Pharmaceuticals, Inc. is the U.S. wholly owned subsidiary of Lupin Limited, and is the 4^th largest pharmaceutical company in the U.S. based on prescriptions filled. Together, all Lupin-owned entities combine to make up the 7^th largest pharmaceutical company in the world in total sales. Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality medications trusted by healthcare professionals and women across many treatment areas. Lupin Pharmaceuticals Inc.’s branded pharmaceuticals division, headquartered in Baltimore, MD, is the provider of numerous products designed to help prevent and manage women’s health conditions with serious health consequences.

© 2018 Lupin Pharmaceuticals, Inc. All rights reserved.

Solosec™ is a trademark owned by Lupin Inc.

REFERENCES
1.	SOLOSEC [prescribing information]. Baltimore, MD: Lupin Pharmaceuticals, Inc; 2017.
2.	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.
3.	Koumans E.H., Sternberg M, Bruce C, et al. (2007) “The Prevalence of Bacterial Vaginosis in the United States, 2001-2004: Associations with Symptoms, Sexual Behaviors, and Reproductive Health.” Sex Transm Dis. 34(11): 864-869.
4.	https://www.cdc.gov/std/bv/stdfact-bacterial-vaginosis.htm.
5.	Data on File.
6.	Brotman RM. Vaginal microbiome and sexually transmitted infections: an epidemic perspective. J Clin Invest. 2011;121(12):4610-4617.
7.	Centers for Disease Control and Prevention. Bacterial Vaginosis. 2015 Sexually Transmitted Diseases Treatment Guidelines. www.cdc.gov/std/tg2015.… Updated June 4, 2015. Accessed Feb 1, 2018.
8.	Bilardi J, Walker S, McNair R, et al. Women’s management of recurrent bacterial vaginosis and experience of clinical care: a qualitative study. PLoS One. 2016;11(3):e0151794. Doi:10.1371/journal.pone.0151794. eCollection 2016. Accessed August 23, 2017.
9.	Schwebke JR, Morgan FG Jr, Koltun W, Nyirjesy P. A phase-3, double-blind, placebo-controlled study of the effectiveness and safety of single oral doses of secnidazole 2 g for the treatment of women with bacterial vaginosis. Am J Obstet Gynecol. 2017;217(6):678. e1- 678.e9. doi: 10.1016/j.ajog.2017.08.017.
10.	Chavoustie SE, Eder SE, Koltun WD, et al. Experts explore the state of bacterial vaginosis and the unmet needs facing women and providers. Int J Gynaecol Obstet. 2017;137:107-109.
11.	Hillier SL, Nyirjesy P, Waldbaum AS, et al. Secnidazole treatment of bacterial vaginosis: a randomized controlled trial. Obstet Gynecol. 2017 Aug;130(2):379-386.