Title: Nonprescription Drugs and Dermatologic and Ophthalmic Drugs Joint Advisory Committee Meeting Overthe
1 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
2Agenda
- Marketing History
- Clinical Experience
- Consumer Experience
- Consumer Research
- Labeling Recommendations
- Conclusions and Recommendations
Schering-Plough HealthCare Products
3Schering-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
4Antifungal 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
5Clinical 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
6Clinical 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
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7Consumer 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
8Consumer 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
9Consumer 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
10Consumer 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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11Consumer 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
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12Consumer 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
13Recommended 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
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14Complications 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
15Recommended 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
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16Conclusions 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