Nonprescription Drugs and Dermatologic and Ophthalmic Drugs Joint Advisory Committee Meeting Overthe

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Nonprescription Drugs and Dermatologic and
Ophthalmic Drugs Joint Advisory Committee
Meeting Over-the-CounterAntifungal Drug
ProductsTreatment of Tinea pedisMay 6, 2004

• Schering-Plough HealthCare Products

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Agenda

• Marketing History
• Clinical Experience
• Consumer Experience
• Consumer Research
• Labeling Recommendations
• Conclusions and Recommendations

Schering-Plough HealthCare Products
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Schering-Plough

• has been a leader in research and marketing
  of Rx and over-the-counter (OTC) topical
  antifungals for the treatment of tinea for more
  than 40 years

Schering-Plough HealthCare Products
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Antifungal Products

• Marketed since 1960s
• Developed tolnaftate and clotrimazole
• Products represent 44 of the OTC antifungal
  market in units sold
• Brands include
• Lotrimin Ultra Cream Lotrimin
  AF
• Tinactin
  Aftate
• Dr. Scholls
• Antifungal agents include
• Butenafine hydrochloride Tolnaftate
• Clotrimazole
  Miconazole nitrate

Schering-Plough HealthCare Products
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Clinical Experience

• Clinical trials of a variety of designs have
  demonstrated the safety and efficacy of these
  products at current dosing levels
• Even though study endpoints have changed
  dramatically over the past four decades,
  significant clinical efficacy has consistently
  been demonstrated

Schering-Plough HealthCare Products
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Clinical Efficacy Endpoints

• Complete cure endpoint definition is an
  unrealistic parameter of efficacy based on
  natural course of healing
• Effective treatment is a more appropriate
  descriptor of efficacy
• Negative mycology (negative culture and KOH)
• Minimal erythema and scaling

Schering-Plough HealthCare Products
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Consumer Experience

• All antifungal ingredients had successful Rx
  clinical experience
• More than 230,000,000 units sold OTC since 1991
• Extensive patient and consumer experience
  confirms that these products are very effective
• Complaints regarding lack of efficacy are
  extremely low 2 per million units sold over past
  5 years
• Consumer experience confirms satisfaction with
  current OTC products

Schering-Plough HealthCare Products
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Consumer Research Data

• Consumer Tracking Studies conducted annually for
  past 10 years provide excellent view of consumer
  experience with condition and treatment
• Most recent study - October 2003
• Approximately 350 consumers, 18-64 yrs old
• Suffered from athletes foot in the past 12
  months
• 70 male, 30 female
• Research is conducted via an internet survey

Schering-Plough HealthCare Products
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Consumer Research Data

• Consumers purchase OTC topical antifungals driven
  by need for symptom relief
• Universally treated by consumers 95
• 80 purchase 4-week products
• 20 purchase lt 4-week products
• Intense itching and burning are primary treatment
  drivers
• 69 rate symptoms as very bothersome/bothersome
  

Schering-Plough HealthCare Products
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Consumer Research Data

• Relief begins within a matter of a few days
  following initiation of treatment
• Provides fast relief 60
• Consumers tend to discontinue use after relief of
  symptoms
• Average treatment period 7.3 days!

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Consumer Research Data

• Shorter treatment options have not dramatically
  changed consumer treatment behavior
• 1997 Study 8.8 days average treatment
• 2003 Study 7.3 days average treatment
• Only 6 report treatment of gt14 days
• More than 50 treat 5 days or less on average
• Overall consumer satisfaction with OTC
  antifungals is strong 86
• 42 report experiencing athletes foot less often
  now than 2 years ago

Schering-Plough HealthCare Products
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Consumer Research DataConclusions

• Consumers are highly satisfied with performance
  of currently marketed OTC topical antifungals
• Consumers consistently experience fast relief of
  symptoms
• Therefore, most consumers do not use their
  product for the entire duration of the labeled
  treatment period

Schering-Plough HealthCare Products
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Recommended Enhanced Labeling

• Therapeutic success can be enhanced by an
  additional label statement under Directions to
  reinforce the need to use for the full treatment
  period
• ? use daily as directed for the full
• treatment time, even if symptoms improve

Schering-Plough HealthCare Products
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Complications Related to Tinea Pedis

• Occurrence of other infections, such as
  cellulitis, is extremely rare
• No published literature associating cellulitis
  and topical antifungals
• FDA reports only 13 cases of cellulitis
  associated with Rx and OTC topical antifungal
  use over the past 30 years
• Some cases are related to non-tinea uses

Schering-Plough HealthCare Products
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Recommended Enhanced Labeling

• Concerns of other infections can be addressed
  through an additional Warning statement
• Stop use and ask a doctor if
• ? there is no improvement in 14 days
• or condition worsens

Schering-Plough HealthCare Products
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Conclusions and Recommendations

• Current products are very effective in treating
  tinea pedis as demonstrated by clinical trials
  and consumer satisfaction
• Products are extremely safe based on extensive Rx
  and OTC marketing history
• Effective Treatment is the appropriate clinical
  endpoint to evaluate product efficacy
• Labeling should be enhanced to improve consumer
  compliance and treatment success

Schering-Plough HealthCare Products