Lupine announces privileged status of SOLOSEC® (secnidazole) on Express Scripts National Preferred Formulary, one of the largest commercial forms in the United States

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Baltimore, Maryland, April 22, 2020 / PRNewswire / – Lupine Pharmaceuticals Inc. (Lupine), the wholly-owned United States-based subsidiary of Lupine Limited, today announced that Solosec® (secnidazole) 2 g oral granules for the treatment of bacterial vaginosis (BV) in adult women received preferential coverage effective immediately on the Express Scripts National Preferred, Flex and Basic commercial forms. As the preferred drug, Solosec® will be available at a lower cost to Express Scripts plan members represented compared to BV drugs which are not preferred or excluded.

Solosec® is the only 2 g single oral dose treatment for the most common vaginal infection in the United States in women of childbearing potential. This next-generation treatment is designed to deliver a complete treatment in one package[1,2].

“As one of the largest pharmacy benefit managers in the United States, Express Scripts’ decision to include Solosec® as a preferred agent on its national formulas is an important step in ensuring access for patients with BV ”, said Ms. Vinita Gupta, CEO of Lupine Limited. “We believe our pricing and access strategy puts patients first by offering them a new, first-of-its-kind BV treatment at a price 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 force them to choose between days of messy pills or creams, abstain from alcohol and use some form of birth control. extra. [4,5] – all this makes completing treatment a challenge [2,3]. In fact, studies show that the longer and more complex a drug regimen, the more it can lead to poor adherence and treatment failure.[6]. It only takes a packet of Solosec® to complete the treatment [1] and the single dose stays in the body and continues to treat BV for four days without alcohol restriction: in vitro studies on medicinal alcohol show that Solosec® does not inhibit the enzyme that metabolizes alcohol[1].

“With over four million women treated for BV each year in the United States and only 50 percent performing 5-7 day treatments, there is a clear need for an effective single-dose oral treatment option that normalizes symptoms of BV without using creams or one-week regimens to improve adherence, ”said Jon Stelzmiller, President – Specialty, Lupine. “We are proud that Lupine has been at the forefront of promoting safe and affordable health care for women around the world 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 an antimicrobial agent based on 5-nitroimidazole 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, to other components of the formulation or to other nitroimidazole derivatives.
  • Vulvovaginal candidiasis may develop with SOLOSEC and require treatment with an antifungal agent.
  • The potential risk of carcinogenicity in patients taking a single dose of SOLOSEC to treat bacterial vaginosis is not clear. Chronic use should be avoided.
  • SOLOSEC® can pass into breast milk. Patients should discontinue breast-feeding for 96 hours after administration of SOLOSEC®.
  • SOLOSEC® is a single dose therapy for oral use. The entire content of SOLOSEC® the sachet should be sprinkled over 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® The 2 g 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 Lupine Pharmaceuticals, Inc. at 1-844-SOLOSEC (1-844-765-6732) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for full prescribing information.

About Lupine Pharmaceuticals, Inc.

Lupine Pharmaceuticals, Inc. is the United States-based wholly owned subsidiary of Lupine Limited, and is the 3rd largest pharmaceutical company in the United States based on total number of prescriptions Together, all entities owned by Lupine combine to form 8e the world’s largest generic pharmaceutical company in terms of sales. Lupine Pharmaceuticals, Inc. is dedicated to providing high quality drugs in many treatment areas. The branded pharmaceutical division of Lupine Pharmaceuticals Inc. is the supplier of products designed to help prevent and manage women’s health problems with serious health consequences.

© 2020 Lupine Pharmaceuticals, Inc. All rights reserved.

Solosec® is a registered trademark owned by Lupine Inc.

THE REFERENCES










1. SOLOSEC® [prescribing information]. Baltimore, MD: Lupine Pharmaceuticals, Inc; 2017.
2. Broumas AG, Basara LA. Potential patient preference for the 3-day treatment of bacterial vaginosis: responses to the 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. Guidelines for the treatment of sexually transmitted diseases 2015. www.cdc.gov/std/tg2015 .… Updated June 4, 2015. Accessed February 1, 2018.
5. Bilardi J, Walker S, McNair R et al. Women’s management of recurrent bacterial vaginosis and clinical care experience: 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 on the efficacy and safety of single oral doses of 2 g secnidazole 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 Lupine Pharmaceuticals, Inc.

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