Differin® (adapalene) Gel, 0.1%

143 Pages·2016·2.99 MB·English

®
Differin (adapalene) Gel, 0.1%
For the treatment of acne
Nonprescription Drugs Advisory Committee
April 15, 2016
CC-1
®
Differin (adapalene) Gel, 0.1%
Howard Marsh, MD
Vice President, Medical Affairs
Galderma
CC-2
Acne is a Common and Chronic Condition
 Affects more than 85% of teenagers but can
occur in most age groups
 Frequently persists into adulthood
 Chronic and recurring condition
 70% of acne sufferers don’t consult their doctor
ZaengleinAL, et al. J Am AcadDermatol. 2016:http://dx.doi.org/10.1016/j.jaad.2015.12.037.
Nielsen Research Survey of Acne Sufferers. 2015.
CC-3
Acne is Highly Visible
CC-4
Acne Has High Psychological Burden
 Acne sufferers can feel:

Self-conscious

Depressed

A lack of confidence

Embarrassment and shame

Socially isolated or withdrawn
HalvorsenJA, et al. J Invest Dermatol.2011;131:363-370
Alexis A, et al. J Drugs Dermatol. 2014;13:330-340.
UhlenhakeE, et al. J CosmetDermatol.2010;9:59-63.
CC-5
Acne is an OTC Condition
 Five active ingredients are allowed for
nonprescription use under the Monograph system
 Benzoyl peroxide and salicylic acid make up 99%
of the OTC acne drug market

Others include sulfur, resorcinol and resorcinol
monoacetate
 No new OTC acne active ingredients since the
1980s
CC-6
What is Adapalene?
 A new chemical entity discovered by Galderma
in 1984
 A third generation retinoid designed to be stable
in the presence of light and oxygen
 Anti-inflammatory and inhibits comedo formation
CC-7
Czernielewski J, et al. J EurAcadDermatolVenerol.2001;15:S5-12.
Seven FDA Approved Adapalene
Formulations
 Differin (adapalene) Gel, 0.1% was approved in 1996
 Approved in 4 other dosage forms and strengths:

0.1% cream, lotion and solution

0.3% gel
 Approved in 2 combination products:

Adapalene 0.1% and 0.3% in combination with benzoyl
peroxide 2.5%
CC-8
Differin Gel Meets General Criteria
for OTC Drugs
 The consumer must be able to self-diagnose
the condition to be treated
 The consumer must be able to read and
understand the product labeling to ensure proper
usage
 The product must be effective when used as
recommended
 The drug must be safe for self-use
CC-9
Consumers Can Self-Diagnose
and Self-Treat Acne
 Self-diagnosed and self-treated by consumers
for decades
 Topical acne drugs are currently marketed OTC
and have been for decades
CC-10