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Efinaconazole 10% solution in the treatment of toenail onychomycosis

Discussion in 'General Issues and Discussion Forum' started by NewsBot, May 17, 2013.

  1. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
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    Efinaconazole 10% solution in the treatment of toenail onychomycosis: Two phase III multicenter, randomized, double-blind studies.
    Elewski BE, Rich P, Pollak R, Pariser DM, Watanabe S, Senda H, Ieda C, Smith K, Pillai R, Ramakrishna T, Olin JT.
    J Am Acad Dermatol. 2013 Apr;68(4):600-8.
     
  2. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Topical treatment of onychomycosis with efinaconazole solution 10%.
    Rich P.
    Cutis. 2013 Jun;91(6):305-7.
     
  3. Admin2

    Admin2 Administrator Staff Member

    Last edited by a moderator: Jun 24, 2014
  4. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Efinaconazole: First Global Approval
    Trina Patel, Sohita Dhillon
    Drugs; November 2013, Volume 73, Issue 17, pp 1977-1983
     
  5. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Efinaconazole (Jublia) for the treatment of onychomycosis
    Aditya K Gupta and Fiona C Simpson
    Expert Review of Anti-infective Therapy 22 May
     
  6. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Efinaconazole 10% Solution in the Treatment of Onychomycosis of the Toenails.
    Warren S. Joseph, Tracey C. Vlahovic, Radhakrishnan Pillai, and Jason T. Olin
    Journal of the American Podiatric Medical Association: September 2014, Vol. 104, No. 5, pp. 479-
     
  7. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Efinaconazole Topical Solution, 10%.
    Richard A. Pollak
    Journal of the American Podiatric Medical Association: November 2014, Vol. 104, No. 6, pp. 568-573.
     
  8. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    The efficacy and safety of efinaconazole 10% solution for treatment of mild to moderate onychomycosis: a pooled analysis of two phase 3 randomized trials.
    Gupta AK, Elewski BE, Sugarman JL, Ieda C, Kawabata H, Kang R, Pillai R, Olin JT, Watanabe S.
    J Drugs Dermatol. 2014 Jul;13(7):815-20.
     
  9. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Efinaconazole topical solution, 10%: the benefits of treating onychomycosis early.
    Rich P.
    J Drugs Dermatol. 2015 Jan;14(1):58-62.
     
  10. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Efinaconazole Topical Solution, 10%: Factors Contributing to Onychomycosis Success
    Richard A. Pollak, William J. Jo Siu, Yoshiyuki Tatsumi and Radhakrishnan Pillai
    J. Fungi 2015, 1(2), 107-114; doi:10.3390/jof1020107
     
  11. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Transungual delivery of efinaconazole: its deposition in the nail of onychomycosis patients and in vitro fungicidal activity in human nails.
    Sakamoto M, Sugimoto N, Kawabata H, Yamakawa E, Kodera N, Pillai R, Tatsumi Y.
    J Drugs Dermatol. 2014 Nov;13(11):1388-92.
     
  12. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
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    Efinaconazole Topical Solution, 10%
    Bryan Markinson and Bryan Caldwell
    Journal of the American Podiatric Medical Association: September 2015, Vol. 105, No. 5, pp. 407-411
     
  13. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Report of a case of a dermatophytoma successfully treated with topical efinaconazole 10% solution.
    Cantrell W, Canavan T, Elewski B.
    J Drugs Dermatol. 2015 May;14(5):524-6.
     
  14. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
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    Efinaconazole topical solution, 10%: formulation development program of a new topical treatment of toenail onychomycosis.
    Bhatt V, Pillai R.
    J Pharm Sci. 2015 Jul;104(7):2177-82. doi: 10.1002/jps.24459
     
  15. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
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    Prognostic Factors for Complete Cure Following Treatment of Mild and Moderate Toenail Onychomycosis With Efinaconazole Topical Solution 10.
    Jellinek NJ, Korotzer A.
    J Drugs Dermatol. 2015 Aug;14(8):871-5.
     
  16. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
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    Efinaconazole and Tavaborole.
    Poulakos M et al
    J Pharm Pract. 2017 Apr;30(2):245-255. doi: 10.1177/0897190016630904.
     
  17. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
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    Efinaconazole solution 10% for treatment of toenail onychomycosis in Latino patients.
    Cook-Bolden FE, Lin T.
    Cutis. 2017 Apr;99(4):286-289.
     
  18. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Is Severity of Disease a Prognostic Factor for Cure Following Treatment of Onychomycosis?
    Elewski BE, Cantrell W, Lin T.
    J Drugs Dermatol. 2018 Feb 1;17(2):175-178.
     
  19. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Topical efinaconazole: A promising therapeutic medication for tinea unguium.
    Noguchi et al
    J Dermatol. 2018 Oct;45(10):1225-1228.
     
  20. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Efficacy of long-term treatment with efinaconazole 10% solution in patients with onychomycosis, including severe cases: A multicenter, single-arm study.
    Iozumi K et al
    JDermatol. 2019 Aug;46(8):641-651
     
  21. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Efinaconazole Topical Solution 10%: Formulation and Efficacy Assessment in the Treatment of Toenail Onychomycosis
    Atefeh Naeimifar Aniseh Samadi Saman Ahmad Nasrollahi Azam Fattahi Zeinab Ghasemi Shadi Azizzadeh‐Roodpishi Shiva Malakooti Amir Hooshang Ehsani Alireza Firooz Yahya Dowlatiy
    Mycoses:11 February 2020
     
  22. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients.
    Shofler D et al
    Clin Podiatr Med Surg. 2020 Apr;37(2):401-407
     
  23. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
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    Press Release:
    FDA Approves Ortho Dermatologics' Labeling For JUBLIA® (efinaconazole) Topical Solution, 10%, In Patients As Young As Six Years Old
    APRIL 29, 2020
    LAVAL, Quebec, April 29, 2020 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for JUBLIA® (efinaconazole) topical solution, 10%, a treatment for onychomycosis, a fungal infection of the toenails, which extends the age range included in the product's label to children six years of age and older.1 JUBLIA was first approved in June 2014 in patients 18 years and older.

    JUBLIA® (efinaconazole) topical solution, 10%

    "Onychomycosis is increasingly being seen in pediatrics - representing 15 percent of all nail dystrophies in children,"2 said Bill Humphries, president, Ortho Dermatologics. "With nearly six years of real-world use since its initial approval to treat adults in 2014, JUBLIA has a demonstrated safety and efficacy profile, and we are pleased the FDA has recognized it as a valuable treatment option for children with toenail fungal infections."

    The safety, pharmacokinetics and efficacy of JUBLIA in patients ages six to 16 years old were evaluated in a multicenter, open-label, single-arm Phase 4 study that enrolled 62 patients with mild-to-severe onychomycosis. The primary objectives were to evaluate the safety of JUBLIA over the 52 weeks of the study in pediatric subjects with at least mild onychomycosis of the toenails, as well as the pharmacokinetics of JUBLIA at four weeks in pediatric subjects 12 to 16 years with moderate-to-severe onychomycosis of the toenails. Efficacy assessments included mycologic cure (fungus-free), complete cure (completely clear nails and fungus-free), and clinical efficacy (<10 percent toenail involvement).3

    In the study, JUBLIA was shown to be well tolerated in the pediatric population. The most common treatment-related side effect was ingrown nails. The systemic exposure to JUBLIA in this pediatric population was comparable to that previously reported in adults. The efficacy assessments showed that by week 52, 65 percent of patients achieved mycologic cure, with a 36.7 percent mycologic cure rate observed as early as week 12. A total of 40 percent of patients had complete cure by week 52, and half of patients achieved clinical efficacy by the study conclusion.3

    "Aside from being a cause of discolored toenails, onychomycosis may cause patients to experience nail discomfort in their shoes and during general activity. In certain populations, it can also potentially lead to a secondary infection," said Tracey Vlahovic, DPM, clinical professor, Department of Podiatric Medicine, and adjunct professor, Department of Microbiology, Temple University School of Medicine. "The expanded labeling for JUBLIA further demonstrates the safety and efficacy of this treatment option, which I look forward to adding to my treatment regimen for pediatric patients."

    Onychomycosis is a chronic fungal nail infection caused predominantly by dermatophyte fungi that typically occurs under the toenail, though fingernails may also be affected. The condition typically begins as a small white or yellow spot beneath the nail, and causes nail discoloration, thickening and/or distortion, pain, detachment of the nail from the nail bed and irregular surface changes. Once onychomycosis begins, it can persist indefinitely if not treated and may cause permanent nail damage.

    Through the company's access program, most eligible, commercially insured patients will pay as little as $0 for both the 4 and 8 mL sizes of JUBLIA.

    For more information on JUBLIA, visit www.jubliarx.com.

    Important Safety Information for JUBLIA® (efinaconazole) Topical Solution, 10%,

    INDICATION
    JUBLIA® (efinaconazole) Topical Solution, 10% is a prescription medicine used to treat fungal infections of the toenails.

    IMPORTANT SAFETY INFORMATION

    JUBLIA is for use on nails and surrounding skin only. Do not use JUBLIA in your mouth, eyes, or vagina. Use it exactly as instructed by your doctor.
    The safety and efficacy of JUBLIA have not been established in children under six years old.
    Before you use JUBLIA, tell your doctor about all your medical conditions, including if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed, because it is not known whether JUBLIA can harm an unborn fetus or nursing infant.
    Tell your doctor about all medications you are taking, and whether you have any other nail infections.
    JUBLIA is flammable. Avoid heat and flame while applying JUBLIA to your toenail.
    JUBLIA may cause irritation at the treated site. The most common side effects include: ingrown toenail, redness, itching, swelling, burning or stinging, blisters, and pain. Tell your doctor about any side effects that bother you or do not go away.
     
  24. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients
    David Shofler et al
    Clin Podiatr Med Surg. 2020 Apr;37(2):401-407
     
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