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Topical Antifungals for T. Pedis Labeling Issues

Topical Antifungals for T. Pedis Labeling Issues. Daiva Shetty, M.D. Division of Over-the-Counter Drug Products (HFD-560) Food and Drug Administration. Outline. Marketing Data Post-marketing Safety Data Labeling of Antifungal Drug Products Concepts for Efficacy Labeling . Marketing Data.

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Topical Antifungals for T. Pedis Labeling Issues

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  1. Topical Antifungals for T. PedisLabeling Issues Daiva Shetty, M.D. Division of Over-the-Counter Drug Products (HFD-560) Food and Drug Administration

  2. Outline • Marketing Data • Post-marketing Safety Data • Labeling of Antifungal Drug Products • Concepts for Efficacy Labeling

  3. Marketing Data

  4. Topical Antifungals for T. Pedis • 11 Rx and OTC NDA active ingredients • 7 OTC monograph active ingredients

  5. IMS Health Use Data • National Sales PerspectivesTM • National Disease and Therapeutic IndexTM (NDTITM)

  6. IMS HealthNational Sales PerspectivesTM • Volume of products • Rx and OTC • Measured in eaches (e.g., tubes or jars) • Does not provide • demographics • indications • amount of drug used

  7. IMS Health National Sales PerspectivesTM 2003 • EachesDollars • OTC 20.1 million $82 million • RX 15.7 million $418.6 million • IMS Health, National PerspectivesTM, 2003, Data Extracted April 2004

  8. National Sales PerspectivesTM 2003 *Products approved for tinea pedisIMS Health, National Sales Perspectives™, 2003, Data Extracted April 2004

  9. IMS Health National Disease and Therapeutic IndexTM • Drugs mentioned during visits to a panel of physicians • 2,000-3,000 office-based physicians • Prescribing patterns • Includes profiles and trends of • diagnoses • patients • treatment patterns • Does not capture patients who self diagnose and purchase OTC products

  10. National Disease and Therapeutic IndexTM 2003: Most Physician Recommended Antifungals for T. Pedis 400,000 24.5% 300,000 15.3% Uses 11.9% 200,000 10.8% 8.6% 100,000 0 Naftifine Econazole Clotrimazole/ Betamethasone Ciclopirox Terbinafine IMS Health, National Disease and Therapeutic IndexTM, 2003, Data extracted April 2004

  11. Post-Marketing Adverse Event Reporting System (AERS) Data

  12. AERS Postmarketing Data • Search of AERS data as of March 16, 2004 for 15 topical antifungal active ingredients (Rx and OTC) • Lack of Efficacy • Cellulitis Cases

  13. AERS Postmarketing Data • Limitations: • No AE reporting requirements for Monograph ingredients • Crude number • Ingredients are marketed in multiple formulations • Several indications for use • Causality not assessed

  14. AERS Data: Lack of Efficacy 4,741 Total AEs for 15 Active Ingredients 1,663 (35%) Lack of Efficacy • 484 Terbinafine (1992) • 297 Clotrimazole (1975) • 287 Miconazole (1973) • 138 Clotrimazole/betamethasone (1984)

  15. 13 Cases Reported as Cellulitis of 4,741 AEs • Ingredients # of reports • Terbinafine 5 • Miconazole 4 • Betamethasone + clotrimazole 1 • Ketoconazole 1 • Tolnaftate 1 • Undecylenic Acid 1

  16. Summary of 13 Cellulitis Cases

  17. Labeling Issues

  18. Labeling • Prescription Labeling • OTC Labeling • Monograph • NDA

  19. Prescription Labeling • Targeted at Healthcare Providers • Detailed Information: • Pharmacology • Microbiology • Preclinical Data • Clinical Efficacy and Safety Data • Indications • Contraindications • Warnings • Dosage and Administration

  20. Example Prescription Labeling:Indications and Usage • “Indicated for the topical treatment of the following dermal infections: Tinea pedis, tinea cruris and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis due to Candida albicans; and tinea versicolor due to Malassezia furfur.”

  21. Example Prescription Labeling:Directions for Use • “XXX should be applied to affected and immediately surrounding areas once to twice daily in patients with tinea pedis, tinea corporis, or tinea cruris. Tinea corporis, tinea cruris, and tinea (pityriasis) versicolor should be treated for 2 weeks and tinea pedis for 1 month to reduce the possibility of recurrence.”

  22. Example Prescription Labeling: Expectations of Treatment • “If a patient shows no clinical improvement after 4 weeks of treatment, the diagnosis should be reviewed.”

  23. OTC Monograph Labeling

  24. OTC Monograph Labeling

  25. OTC Monograph Labeling  use daily for 4 weeks. If condition persist longer, ask a doctor.

  26. OTC Monograph Labeling Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks.

  27. OTC NDA Labeling

  28. OTC NDA Labeling

  29. OTC NDA Labeling 4 weeks If condition persists longer, ask a doctor.

  30. OTC NDA Labeling • Directions •  adults and children 12 years and older •  wash the affected skin with soap and water and dry completely before applying • for athlete’s foot apply a thin layer over affected area twice daily (morning and night) for 4 weeks or as directed by a doctor. If condition persists longer, ask a doctor. Supervise children in the use of this product. Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. •  wash hands after each use •  children under 12 years: ask a doctor •  if condition persist longer, ask a doctor •  this product is not effective on scalp or nails 1 week If condition persists longer, ask a doctor.

  31. OTC NDA Labeling Stop use and ask a doctor if too much irritation occurs or gets worse

  32. Concepts for Efficacy Labeling

  33. Concepts for Efficacy Labeling • Most OTC products are indicated for acute symptom relief • Few have a lag time between the treatment initiation and the expected results • This information is presented in Drug Facts or in the Package Insert

  34. Example of Efficacy Labeling: Omeprazole • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect • it may take 1 to 4 days for full effect; although some people get complete relief of symptoms within 24 hours

  35. Example of Efficacy Labeling: Minoxidil • When using this product • it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results.

  36. Example of Package Insert Efficacy Labeling: Famotidine

  37. Considerations for Labeling Revisions • Should the following be in the label? • Efficacy rates • Time to symptom relief • Expected time to cure • When to see a doctor • Ancillary measures

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