Feb 1, 2021   SOURCE: PR NewsWire

Lupin Announces Partnership with Phil, Inc. in Support of SOLOSEC® (secnidazole)

MUMBAI, India and BALTIMORE, Feb. 1, 2021 /PRNewswire/ -- Lupin Pharmaceuticals Inc. (Lupin), global pharmaceutical company, announced today a partnership with Phil, Inc., which helps deliver cost-effective next-generation access solutions for patients who are prescribed Solosec® (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women.

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Solosec® is the only single 2g oral dose therapy for the most common vaginal infection in the U.S. among adult women. This treatment is designed to deliver a full course of therapy in just one packet.(1) In November, Lupin announced that the U.S. Food and Drug Administration (FDA) has accepted its 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.

"With the addition of Solosec® to the Phil platform, we are able to provide a convenient channel for physicians to prescribe Solosec® and enhance the patient experience," said Jon Stelzmiller, President - Specialty, Lupin Pharmaceuticals, Inc. "We are proud that Lupin has been at the forefront of advancing affordable healthcare for women globally for decades and we are committed to helping prevent and manage women's health conditions, including BV."

"Phil offers a systemic solution for a systemic problem," Deepak Thomas, Founder and CEO of Phil, Inc., said in a statement. "Because the underlying challenges in this space are experienced not just at the pharmacy but may extend to other stakeholders including prescribers and manufacturers, Phil aims to address these issues in their entirety."

Solosec® is designed to be a single dose treatment for patients with BV. (1) Because Solosec® is taken in one oral dose, it may be preferred by people who do not want to use a vaginal cream or take pills over multiple days. (1-3) Studies reveal that the longer and more complex a drug regimen is, the more it may lead to poor adherence and treatment failure. ([4,5]) The single dose of Solosec® stays in the body and continues to treat BV for four days without any alcohol restriction; in vitro drug alcohol studies show Solosec® does not inhibit the enzyme that metabolizes alcohol. (1) Solosec® was also shown not to interact with a common oral contraceptive: combination ethinyl estradiol and norethindrone. (1)

INDICATION

Solosec® (secnidazole) 2 g oral granules is a 5-nitroimidazole antimicrobial agent indicated for the treatment of bacterial vaginosis 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 click here for full Prescribing Information.

Solosec® is a registered trademark owned by Lupin, Inc. NP-SOL-0176

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 -



       
              Shweta Munjal        
     
              Arvind Bothra                    
     
              Manjira Sharma


       Head - Corporate Communications 
     Head - Investor Relations and Corporate M&A 
     General Manager - Corporate Communications


       Email: shwetamunjal@lupin.com   
     Email: arvindbothra@lupin.com               
     Email: manjirasharma@lupin.com

    ---

About Phil

Phil Inc., headquartered in San Francisco, California, is a leading provider of Digital Patient Access Solutions. By addressing patient access challenges using online technologies, as opposed to traditional call-center models, Phil Inc. partners with pharmaceutical manufacturers to deliver pioneering digital access to Specialty and Specialty-Lite therapies. Phil Inc's access solutions may improve patient outcomes by lowering cost and improving speed to therapy, while freeing up prescribers and pharmacists to focus on delivering care.

References:

(1) SOLOSEC [prescribing information]. Baltimore, MD: Lupin Pharmaceuticals, Inc; 2019.

(2) American College of Obstetricians and Gynecologists. ACOG Practice Bulletin: Clinical Management Guidelines for Obstetricians-Gynecologists, Number 215. Obstet Gynecol 2020:135(1):e1-e17.

(3) Data on File, Physician Research. Advantage Healthcare, Inc. Prepared December 23, 2014.

(4) 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.

(5) Bartley JB, Ferris DG, Allmond LM, Dickman ED, Dias JK, Lambert J. Personal digital assistants used to document compliance of bacterial vaginosis treatment. Sex Transm Dis. 2004;31(8):488-491.

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SOURCE Lupin Pharmaceuticals, Inc.