Lupin Announces SOLOSEC® (secnidazole) Achievement of Preferred Status on Express Scripts National Preferred Formulary, One of the Largest Commercial Formularies in the U.S.

News provided by

Lupin Pharmaceuticals, Inc.

Apr 22, 2020, 07:23 ET

BALTIMORE, Maryland, April 22, 2020 /PRNewswire/ -- Lupin Pharmaceuticals Inc. (Lupin), the U.S. based wholly owned subsidiary of Lupin Limited, announced today that Solosec® (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women has received preferred coverage effective immediately on the Express Scripts National Preferred, Flex, and Basic commercial formularies. As a preferred medication, Solosec® will be available at a lower out-of-pocket cost to the represented Express Scripts plan members compared to BV medications which are non-preferred or excluded.

Solosec® 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].

"As one of the largest pharmacy benefit managers in the U.S., Express Scripts' decision to include Solosec® as a preferred agent on its national formularies is a significant step toward ensuring access to it for BV patients," said  Ms. Vinita Gupta, CEO of Lupin Limited. "We believe our pricing and access strategy prioritizes patients by providing a novel, first-of-its-kind BV treatment at pricing designed to reduce barriers to treatment with Solosec®."

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 [4,5] – all of which make completing treatment a challenge [2,3]. 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[6]. 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 Jon Stelzmiller, President - Specialty, Lupin. "We are proud that Lupin has been at the forefront of advancing safe and affordable healthcare for women globally for decades and is committed to helping prevent and manage women's health conditions with serious consequences, including BV," he added.

Indication

SOLOSEC® (secnidazole) 2g oral granules is a 5-nitroimidazole antimicrobial agent indicated for the treatment of bacterial vaginosis (BV) 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 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.

© 2020 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. Data on File.
4. 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.
5. 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.
6. 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.















SOURCE Lupin Pharmaceuticals, Inc.

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