About Solosec
ACOG Treatment Guidelines
ACOG adds Solosec to BV guidelines3*†
Secnidazole has comparable efficacy to a 7-day metronidazole regimen for the treatment of BV.3
ACOG states that the choice of therapy should be individualized based on:
Patient Preference
Patient Preference
9 out of 10 patients who responded to a recent survey were satisfied, very satisfied, or extremely satisfied with the result of their Solosec treatment4‡
9 out of 10 patients who responded to a recent survey were satisfied, very satisfied, or extremely satisfied with the result of their Solosec treatment4‡
Cost
Cost
Commercially insured patients may pay as little as $25 for Solosec with co-pay card§
Commercially insured patients may pay as little as $25 for Solosec with co-pay card§
Convenience
Convenience
Solosec can be taken at any time of day, without regard to the timing of meals2
Solosec can be taken at any time of day, without regard to the timing of meals2
Adherence
Adherence
Solosec delivers a full course of antibiotic therapy in just one oral dose2
Solosec delivers a full course of antibiotic therapy in just one oral dose2
Ease of Use
Ease of Use
Solosec is a single oral dose taken mixed with applesauce, yogurt, or pudding—no intravaginal creams or multiple days of pills2,3,5
Solosec is a single oral dose taken mixed with applesauce, yogurt, or pudding—no intravaginal creams or multiple days of pills2,3,5
History of Response or Adverse Reactions to Previous Treatments3
History of Response or Adverse Reactions to Previous Treatments3
In pivotal studies, treatment with Solosec of patients with recurrent BV showed similar efficacy compared to the overall population studied.6,7¶
In pivotal studies, treatment with Solosec of patients with recurrent BV showed similar efficacy compared to the overall population studied.6,7¶
* American College of Obstetricians and Gynecologists
† From the January 2020 ACOG Practice Bulletin regarding clinical management guidelines for vaginitis in non-pregnant patients.
‡ More than 4,000 Solosec kits were distributed to healthcare professionals, including a Solosec voucher, patient brochure, dosing card, and instruction card on how to participate in a brief voluntary survey. 1,888 Solosec vouchers were redeemed and 85 surveys were completed (N=85) in a nonscientific survey conducted by Lupin Pharmaceuticals. Numbers have been rounded.4
§ Per fill. Not valid for any person eligible for reimbursement of prescriptions, in whole or in part, by any state or federally funded program, including Medicare, Medigap, or Medicaid, or where prohibited, taxed or otherwise restricted by law. Cash-pay patients may pay as little as $75. Eligibility requirements and terms and conditions apply. See solosechcp.com/savings for details.
¶ Study 1 enrolled 215 nonpregnant female patients aged 19-54 years. Efficacy was assessed at the test of cure (TOC) visit after 21-30 days, following initial treatment with a single dose of Solosec.6 Study 2 enrolled 189 nonpregnant female patients aged 18-54 years. Efficacy was assessed after 7-14 days in an interim visit and at the TOC visit after 21-30 days, following initial treatment with a single dose of Solosec.7
Solosec Clinical Study 1
In pivotal studies, Solosec demonstrated statistically and clinically significant efficacy in the treatment of BV2,6,7
Study 1 Design
In Study 1, Solosec was statistically superior to placebo in all primary and secondary efficacy endpoints2,6
Clinical Cure Rate in Study 12,6*†
* 188 women were included in the mITT group. Reasons for exclusion from the mITT group included baseline STIs (n=13 women), Nugent score < 4 at start of study (n=14), and clinically significant baseline laboratory abnormality that led to a diagnosis of chronic myeloid leukemia (n=1). Patients missing ≥ 1 of the clinical assessments were considered non-responders/not cured2,6
† Clinical cure defined as normal vaginal discharge, negative 10% KOH whiff test, and clue cells <20% of total epithelial cells on microscopic examination at the TOC/EOS visit.6
Secnidazole and Metronidazole Noninferiority Study
Secnidazole 2 g oral granules in France8
Treatment of Bacterial Vaginosis: A Multicenter, Double-Blind, Double-Dummy, Randomized Phase III Study Comparing Secnidazole and Metronidazole8
- Secnidazole formulation may differ from Solosec
- Not a pivotal trial for Solosec approval
The single-dose secnidazole was non-inferior to the multiple-dose metronidazole regimen8*
* Clinical cure defined as the normalization of the three Amsel criteria. 95% CI Secnidazole-Metronidazole [-0.098; 0.052].8
No Alcohol Restriction
Solosec has no alcohol restriction; in vitro drug alcohol studies showed it does not interact with aldehyde dehydrogenase2
Watch the video to understand the mechanisms at work:
Patient Satisfaction
What surveyed patients said about Solosec4*:
9 out of 10 patients who responded to a recent survey4*:
Were satisfied, very satisfied, or extremely satisfied with the result of their Solosec treatment4
Would recommend to a friend with BV that they speak to their doctor about Solosec4
8 out of 10 patients4*:
Found it easy to take their Solosec dose4
Would request Solosec again if diagnosed with BV in the future4
Found it useful, very useful, or extremely useful to know that Solosec has no alcohol restriction4†
* More than 4,000 Solosec kits were distributed to healthcare professionals, including a Solosec voucher, patient brochure, dosing card, and instruction card on how to participate in a brief voluntary survey. 1,888 Solosec vouchers were redeemed and 85 surveys were completed (N=85) in a nonscientific survey conducted by Lupin Pharmaceuticals. Numbers have been rounded.4
† In vitro drug alcohol studies show Solosec does not interact with aldehyde dehydrogenase.2
BV Treatment Options
With Solosec, patients may benefit from a single oral dose BV treatment regimen
Current BV-indicated treatments*
The comparative efficacy of Solosec and the listed treatments has not been adequately studied. This is not a complete list of attributes for each product that may be important to a clinical decision. For the most updated information, consult the PI for each product.
* Solosec® is a registered trademark owned by Lupin Inc.; Flagyl® is a registered trademark of G.D. Searle & Go; Tindamax® is a registered trademark of Mission Pharmacal Company and is not associated with Edenbridge Pharmaceuticals LLC; Clindesse® is a registered trademark of Perrigo Pharma International D.A.C., a Perrigo company; Metrogel® is manufactured by Teva Pharmaceuticals USA; Nuvessa® is a registered trademark of Chemo Research, S.L.
† In vitro drug alcohol studies showed Solosec does not interact with aldehyde dehydrogenase2
‡ Combination oral contraceptive ethinyl estradiol plus norethindrone2
§ QIDP= Qualified Infectious Disease Product. FDA QIDP designation established in 2012. Granted to certain antibacterial and anti-fungal drugs for human use intended to treat serious or life-threatening infections. Designation not applicable to or available to drugs or marketing applications approved before 2012.
Dosing and Administration
Solosec is designed to be easy to take5
Solosec is designed to be easy to take5
Open the packet and sprinkle the entire contents of the packet onto applesauce, yogurt, or pudding2
Stir and mix2
Consume all of the mixture within 30 minutes. DO NOT CHEW OR CRUNCH THE GRANULES2
Note: Patients can drink a glass of water after taking Solosec to help with swallowing, if needed. Do not try to dissolve the medicine in water or any other liquid2
Note: Patients can drink a glass of water after taking Solosec to help with swallowing, if needed. Do not try to dissolve the medicine in water or any other liquid2
FAQs
Frequently asked questions about Solosec:
What do the granules look like?
Watch the video below to see how the Solosec granules will appear to your patients, and how they're taken mixed with food:
How long does Solosec stay in the body?
Solosec has a prolonged elimination half-life of 17 hours and stays in the body for 5 days following a single dose.2,14
MEAN PLASMA CONCENTRATION OVER TIME2, 14, 15
This is a representation of two products' pharmacokinetic profiles.
MEAN PLASMA CONCENTRATION OVER TIME2,14,15
This is a representation of two products' pharmacokinetic profiles.
What lifestyle restrictions and dosing schedule guidelines should my patients be aware of when taking Solosec?
Solosec can be taken at any time of the day2
Breastfeeding is not recommended. Patients should discontinue breastfeeding for 96 hours after administration of SOLOSEC.
With Solosec, there is no restriction on drinking alcohol2
- In vitro drug alcohol studies showed Solosec does not interact with aldehyde dehydrogenase2
Solosec can be taken without regard to the timing of meals2
There are no food restrictions during Solosec treatment.2
Do patients need to use back-up birth control while on Solosec?
Solosec was shown not to interact with a common oral contraceptive: combination ethinyl estradiol and norethindrone.2
What side effects should I instruct my patients to watch for?
The most common adverse reactions observed in clinical trials (incidence ≥2%) were vulvovaginal candidiasis, headache, nausea, dysgeusia, vomiting, diarrhea, abdominal pain, and vulvovaginal pruritus.2
Vulvo-vaginal candidiasis may develop with Solosec and require treatment with an antifungal agent.2
How can my patients save on Solosec?
Lupin Pharmaceuticals, Inc. offers a co-pay card program that can help patients save at the pharmacy.
References:
- Data on File – IQVIA Monthly & Weekly TRx Data in SMART, U.S. Edition – Weekly and Monthly NPA Data (Assessed as of May 2020). Prepared May 2020.
- SOLOSEC [prescribing information]. Baltimore, MD: Lupin Pharmaceuticals, Inc.; 2019.
- American College of Obstetricians and Gynecologists. ACOG Practice Bulletin: Clinical Management Guidelines for Obstetricians-Gynecologists, Number 215. Obstet Gynecol 2020:135(1):e1-e17.
- Data on file. Experience Program: Post Treatment Patient Survey data (May 2019-Sep 2019). Prepared September 2019. (LPSO-23506). Lupin Pharmaceuticals, Inc.
- Data on File, Physician Research. Advantage Healthcare, Inc. Prepared December 23, 2014.
- Hillier SL, Nyirjesy P, Waldbaum AS, et al. Secnidazole treatment of bacterial vaginosis: a randomized controlled trial. Obstet Gynecol. 2017;130(2):379-386.
- 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 [published correction appears in Am J Obstet Gynecol. 2018;219(1):110]. Am J Obstet Gynecol. 2017;217(6):678.e1-678.e9. doi: 10.1016/j.ajog.2017.08.017.
- Bohbot JM, Vicaut E, Fagnen D, Brauman M. Treatment of bacterial vaginosis: a multi-center, double-dummy, randomized phase III study comparing secnidazole and metronidazole. Infect Dis Obstet Gynecol. 2010;2010:1-6.
- Flagyl Extended Release [prescribing information]. Chicago, IL: G.D. Searle LLC; 2018.
- Tinidazole Tablets [prescribing information]. Buffalo Grove, IL: G.D. PACK Pharmaceuticals, LLC; 2013.
- Clindesse [prescribing information]. Allegan, MI: Pharmacia & Upjohn Company, LLC; 2014.
- Metrogel [prescribing information]. Sellersville, PA: Teva Pharmaceuticals USA; 2005.
- Nuvessa [prescribing information]. Madrid, Spain: Chemo Research SL; 2017.
- Nyirjesy P, Schwebke JR. Secnidazole: next-generation antimicrobial agent for bacterial vaginosis treatment. Future Microbiol. 2018;13:507-524. doi:10.2217/fmb-2017-0270.
- Metronidazole Oral Capsules 500 mg [prescribing information]. Chicago, IL: G.D. Searle LLC; 2018.
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LUPIN'S PLEDGE ON PRIVACY ("PLEDGE")
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CATEGORIES OF PERSONAL DATA
As most of our website content is informational and does not require account creation or registration, individuals may access many parts of our websites and online resources without disclosing any Personal Data. However, where we do collect Personal Data, we do so online through websites and other online resources. We also offer online resources in collaboration with other online service providers, from which we may receive Personal Data about users of such resources. These online collaborations are governed by agreements that require Personal Data to be protected appropriately. There are three methods that we use to collect Personal Data on our Website:
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INTENDED USE OF PERSONAL DATA
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STATEMENT ON CHILDREN
In general, our websites and online resources are not directed at children and most of the online services that we offer are designed for individuals who are 18 years of age or older. Where requests for information about a medication are permitted by law, individuals requesting information about a medication that is indicated for use in children must be 18 years or age or older.
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YOUR CHOICES
You may choose not to provide any Personal Data to us online by electing not to enter any Personal Data into a form or data field on our websites, and by not using any personalized services provided by our online resources. However, some of our online resources require users to identify themselves in order to use personalized services or advanced features, which will not be available without such data.
Some of our websites may request your permission to use and disclose Personal Data about you in order to add you to our contact lists, to enable you to list yourself in a directory or social media resources, and to identify and offer additional services and promotions that we believe you might find interesting. You can limit the use of Personal Data about you by checking or un-checking options provided at the time that you enter that information or that we may offer to you in the future. Additionally, you may change your communications preferences (such as to opt-out of communications you requested previously) by using the opt-out link provided in our electronic communications or by contacting us at ComplianceOffice@Lupin.com.
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NON-DISCLOSURE OF INFORMATION
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Cookies & Other Tracking Technologies.
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We may combine information from Cookies with Personal Data, including data obtained from third parties.
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YOUR CALIFORNIA PRIVACY RIGHTS
If you are a California resident, California law may provide you with additional rights regarding our use of your personal information. California's "Shine the Light" law (Civil Code Section § 1798.83) permits users of our Website that are California residents to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes. To make such a request, please send an email to ComplianceOffice@Lupin.com or write to us at: 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108.
SECURITY AND CONFIDENTIALITY
We use commercially reasonable technical and organizational measures to help secure Personal Data against loss, misuse, and alteration appropriate to the type of Personal Data processed. If a breach of your Personal Data occurs, we will notify you of the breach if required under applicable law.
YOU UNDERSTAND THAT NO DATA TRANSMISSION OVER THE INTERNET OR DEVICE CAN BE GUARANTEED TO BE 100% SECURE. WHILE WE STRIVE TO PROTECT PERSONAL DATA, WE DO NOT GUARANTEE THE SECURITY OF PERSONAL DATA AND YOU PROVIDE PERSONAL DATA AT YOUR OWN RISK.
RECORD RETENTION
We generally retain Personal Data for only as long as reasonably needed for the specific business purpose or purposes for which it was collected and the duration of your use of our websites. In some cases, we may be required to retain information for a longer period of time based on laws or regulations that apply to our business, such as applicable rules on statute of limitations or for other necessary business purposes. Where possible, we aim to anonymize the information or remove unnecessary identifiers from records that we may need to keep for periods beyond the original retention period.
LINKS TO OTHER SITES
This Website Privacy Pledge applies only to Lupin's websites. The Site may link to, or be linked to, websites not owned or controlled by us. We are not responsible for third-parties' privacy policies or practices. This Policy does not apply to any third-party websites or to any data that you provide to third parties. You should read the privacy policy for each website that you visit.
CONTACT
We aim to constantly improve the tools available to you to manage the data that you provide to us. We may update this policy periodically. We reserve the right to modify, add or remove portions of this Website Privacy Pledge at our discretion. If we decide to change this Pledge, we will post those changes at this site on our homepage so you always will know what information we gather, how we might use that information, and whether we will disclose it to anyone. Please refer to this page from time to time to review these and other new features or updates. This policy was last updated on May 4, 2020.
Terms of Use
Please carefully read these Terms of Use and our Privacy Policy before using our Website. By using the Lupin Website, you agree to follow and be bound by these Terms of Use and our Privacy Policy without modification. In the case of any violation of these Terms of Use, Lupin reserves the right to seek all remedies available at law and in equity for such violation. Because we will continue to implement new technologies and improve the services and features we provide on our Website, this statement is subject to change without prior notice. For that reason, we encourage you to review this statement periodically. By using our Website, you agree to the Terms of Use in effect at that time.
Use of Website
The Lupin Website may contain other proprietary notices and copyright information, the terms of which must be observed and followed. Information on this Website may contain technical inaccuracies or typographical errors. Information may be changed or updated without notice. Lupin reserves the right to refuse service in its discretion, including, without limitation, if Lupin believes that customer conduct violates applicable law or is harmful to the interests of Lupin.
Submitted Information
No information or material provided to Lupin by you through our Website may contain vulgar, obscene, threatening or otherwise unlawful language or material. Lupin will not release your name or otherwise publicize the fact that you submitted materials or other information to us unless we obtain your permission to use your name or we are required to do so by law. Please review our Privacy Policy for a complete description of how we handle personal information submitted to us. Lupin Information Lupin has made a conscious effort to display and describe information about Lupin on the site accurately so that you can get a good idea of our business. Furthermore, Lupin is constantly improving its information. The materials on this Website are for your general educational information only. Lupin does not practice medicine or provide medical services or advice, and the information on this Website should not be considered medical advice. You should always rely on your health care professional for diagnosis and treatment.
Trademarks
Lupin's names and logos referenced on the Website are trademarks of Lupin in India and other countries and may not be used in connection with any product or service in any manner that is likely to cause confusion among customers or in any manner that disparages or discredits Lupin.
All other trademarks not owned by Lupin that appear on this Website are the property of their respective owners, who may or may not be affiliated with, connected to, or sponsored by Lupin. If you use the materials or trademarks on this Website in a way that is not clearly allowed by these Terms of Use, you are violating your agreement with us and may be violating copyright, trademark, and other laws. In that case, we automatically revoke your permission to use this Website. Title to the materials remains with us or with the authors of the materials contained on this Website. All rights not expressly granted are reserved.
Change to Term of Use
Lupin reserves the right to update the Terms of Use statement at any time. Any changes or updates will be effective immediately upon posting to this Website. Your use of this Website constitutes acceptance of our Terms of Use. If you do not agree to the terms, please exit from this Website immediately.
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