Differin
Anti-Acne Medication Cleared by FDA
FORT WORTH, Texas, June 3, 1996
Galderma Laboratories announced that it has
received marketing clearance for Differin(TM) (adapalene gel) Gel, 0.1%, a new
topical prescription anti-acne medication.
Differin(TM) Gel is a new synthetic retinoid analogue with advanced receptor
selective activity and potent anti-inflammatory and comedolytic properties.
Differin(TM) Gel is the first new retinoid for the treatment of acne since oral
isotretinoin (Accutane(R), Roche) was introduced in 1982, and the first new
topical retinoid since tretinoin (Retin-A(R), Ortho) in 1972(a). In controlled
clinical trials, Differin(TM) Gel was shown to effectively reduce the number
and severity of acne lesions after 12 weeks of therapy and has demonstrated
greater effectiveness than the highest strength of topical tretinoin gel
(0.025% gel). Furthermore, the patients on Differin(TM) Gel experienced
significantly less skin dryness and skin irritation(b). Stinging, burning,
peeling and skin redness associated with retinoid therapy have been a barrier
to patients remaining on their tretinoin acne medication and achieving
successful treatment outcomes.
"Retinoid therapy has been recognized for more than 20 years to be
excellent acne therapy, but due to the side effects it has always been a
double-edged sword limiting its use in many patients," said James Leyden,
M.D., professor of dermatology, University of Pennsylvania and a Differin(TM)
Gel clinical investigator. "However, the benefit is that Differin(TM) Gel
is quite effective and tolerance is very good, even continuing to improve with
treatment."
Some adverse effects such as erythema, scaling, dryness, pruritus and burning
will occur in 10%-40% of patients. Pruritus or burning immediately after
application also occurs in approximately 20% of patients. The following
additional adverse experiences were reported in approximately 1% or less of
patients: skin irritation, burning/stinging, erythema, sunburn and acne flares.
These are most commonly seen during the first month of therapy and decrease in
frequency and severity thereafter.
In addition to its excellent tolerability, Differin(TM) Gel offers other
benefits:
- It quickly penetrates deeply into hair follicles, where it can exert its
anti-inflammatory and comedolytic effects (prevention/reduction of
blackheads/whiteheads).
- It is a white, odorless, oil-free and alcohol-free gel that is specifically
formulated for the special needs of patients with acne.
Galderma Laboratories plans to make Differin(TM) Gel available to pharmacies in
the third quarter of 1996.
Galderma Laboratories, a joint venture of L'Oreal and Nestle, is a leading
research-based pharmaceutical company dedicated to developing novel
prescription and over-the-counter treatments for dermatological diseases.
Devoted exclusively to dermatology, the company is focused on treatments for
disease areas including acne, rosacea, psoriasis, eczema and skin infections.
Galderma Laboratories is an international skin care products company with its
U.S. headquarters located in Fort Worth. (a) Plewig, Gerd and Albert M.
Kligman. Acne and Rosacea. New York: Springer-Verlag, p. 556.
(b) A comparison of the efficacy and safety of adapalene gel 0.1% and tretinoin
gel 0.025% in the treatment of acne and vulgaris: A multicentre trial. A
Shalita, MD, JS Weiss, MD, DK Chalker, MD, et al.; Journal of the American
Academy of Dermatology, March 1996.
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