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healthcare professional talking with patient about solosec
healthcare professional talking with patient about solosec




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:


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Patient Preference

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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‡

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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‡

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Cost

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Cost

Commercially insured patients may pay as little as $25 for Solosec with co-pay card§

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Commercially insured patients may pay as little as $25 for Solosec with co-pay card§

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Convenience

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Convenience

Solosec can be taken at any time of day, without regard to the timing of meals2

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Solosec can be taken at any time of day, without regard to the timing of meals2

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Adherence

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Adherence

Solosec delivers a full course of antibiotic therapy in just one oral dose2

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Solosec delivers a full course of antibiotic therapy in just one oral dose2

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Ease of Use

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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

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Solosec is a single oral dose taken mixed with applesauce, yogurt, or pudding—no intravaginal creams or multiple days of pills2,3,5

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History of Response or Adverse Reactions to Previous Treatments3

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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¶

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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


 
solosec clinical study 1 enrollment of nonpregnant female patients secnidazole and metronidazole treatment comparison bar graph




 


In Study 1, Solosec was statistically superior to placebo in all primary and secondary efficacy endpoints2,6



Clinical Cure Rate in Study 12,6*†



solosec clinical cure rate study bar graph versus placebo solosec clinical cure rate study bar graph versus placebo


* 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*





secnidazole and metronidazole treatment comparison bar graph secnidazole and metronidazole treatment comparison bar graph



* 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*:



9 out of 10 women silhouette
9 out of 10 women silhouette



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*:



8 out of 10 women silhouette
8 out of 10 women silhouette


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Found it easy to take their Solosec dose4

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Would request Solosec again
if diagnosed with BV in the future4

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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*



solosec and current treatments for bacterial vaginosis comparison chart
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current treatments for bacterial vaginosis comparison chart
current treatments for bacterial vaginosis comparison chart




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









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Open the packet and sprinkle the entire contents of the packet onto applesauce, yogurt, or pudding2







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Stir and mix2



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Consume all of the mixture within 30 minutes. DO NOT CHEW OR CRUNCH THE GRANULES2

packet of solosec pouring into yogurt
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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

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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





packet of solosec pouring into yogurt

FAQs


Frequently asked questions about Solosec:




green carrot  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:





green carrot  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



MEAN PLASMA CONCENTRATION OVER TIME Graph 1
MEAN PLASMA CONCENTRATION OVER TIME Graph 2



This is a representation of two products' pharmacokinetic profiles.



solosec 2g and metronidazole 500mg pharmacokinetic profile over time graph

MEAN PLASMA CONCENTRATION OVER TIME2,14,15



MEAN PLASMA CONCENTRATION OVER TIME Graph 1
MEAN PLASMA CONCENTRATION OVER TIME Graph 2



This is a representation of two products' pharmacokinetic profiles.



solosec 2g and metronidazole 500mg pharmacokinetic profile over time graph




 

green carrot  What lifestyle restrictions and dosing schedule guidelines should my patients be aware of when taking Solosec?

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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.

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With Solosec, there is no restriction on drinking alcohol2


- In vitro drug alcohol studies showed Solosec does not interact with aldehyde dehydrogenase2

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Solosec can be taken without regard to the timing of meals2


There are no food restrictions during Solosec treatment.2


green carrot  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

green carrot  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

green carrot  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:

  1. 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.
  2. SOLOSEC [prescribing information]. Baltimore, MD: Lupin Pharmaceuticals, Inc.; 2019.
  3. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin: Clinical Management Guidelines for Obstetricians-Gynecologists, Number 215. Obstet Gynecol 2020:135(1):e1-e17.
  4. Data on file. Experience Program: Post Treatment Patient Survey data (May 2019-Sep 2019). Prepared September 2019. (LPSO-23506). Lupin Pharmaceuticals, Inc.
  5. Data on File, Physician Research. Advantage Healthcare, Inc. Prepared December 23, 2014.
  6. Hillier SL, Nyirjesy P, Waldbaum AS, et al. Secnidazole treatment of bacterial vaginosis: a randomized controlled trial. Obstet Gynecol. 2017;130(2):379-386.
  7. 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.
  8. 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.
  9. Flagyl Extended Release [prescribing information]. Chicago, IL: G.D. Searle LLC; 2018.
  10. Tinidazole Tablets [prescribing information]. Buffalo Grove, IL: G.D. PACK Pharmaceuticals, LLC; 2013.
  11. Clindesse [prescribing information]. Allegan, MI: Pharmacia & Upjohn Company, LLC; 2014.
  12. Metrogel [prescribing information]. Sellersville, PA: Teva Pharmaceuticals USA; 2005.
  13. Nuvessa [prescribing information]. Madrid, Spain: Chemo Research SL; 2017.
  14. 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.
  15. Metronidazole Oral Capsules 500 mg [prescribing information]. Chicago, IL: G.D. Searle LLC; 2018.