|[March 22, 2014]
Galderma Announces Positive Results of Phase 3 Trials of Investigational Ivermectin 1% Targeting Papulopustular Rosacea
DENVER --(Business Wire)--
Galderma Laboratories, L.P. today announced the results of two pivotal
phase 3 trials of ivermectin 1%, an investigational drug being evaluated
for the treatment of papulopustular (inflammatory) rosacea. The data
were presented at a Late-Breaking session of the 72nd annual
meeting of the American Academy of Dermatology (AAD). The results of the
studies, in which 910 subjects applied ivermectin 1% cream once daily
for 12 weeks, demonstrate that ivermectin is safe and effective.
Both pivotal studies of ivermectin 1% cream significantly met their
co-primary efficacy endpoints of treatment success as defined by
Investigator Global Assessment (IGA) rating of clear skin, and change in
inflammatory lesion count. In the studies, ivermectin 1%
showed comparable tolerability and safety to its vehicle. Onset (News - Alert)of
treatment effect was observed at week four in both studies.
"Currently, there are a limited number of safe and efficacious topical
medications available to treat chronic papulopustular rosacea," said
Stuart Raetzman, Chief Executive Officer of Galderma Laboratories, L.P.
and Vice President North America. "We at Galderma are hopeful that the
positive phase 3 data from the ivermectin 1% studies will lead to an
additional effective treatment option for our healthcare provider
Both pivotal studies were phase 3 randomized, double-blind, 12-week
vehicle controlled parallel-group studies assessing the efficacy and
safety of ivermectin 1% cream in subjects with papulopustular rosacea.
Both pivotal studies met their co-primary efficacy endpoints. The effect
was significant (p<0.001) in all primary and sensitivity analyses at
Week 12 (ITT (News - Alert)-LOCF). Onset of treatment effect was observed at week 4 in
each study. The first co-primary endpoint was success rate
(percent of subjects ratedclear or almost clear on the IGA rating
scale) at Week 12. In Study 1, 173 subjects (38.4%) were assessed as
success with ivermectin 1% versus 27 subjects (11.6%) with vehicle
(p<0.001). Statistical significance was observed from Week 4 with
success in 49 (10.9%) and 13 (5.6%) patients for ivermectin 1% and
vehicle, respectively. The results were consistent between the studies.
The second co-primary endpoint was reduction in inflammatory lesions,
and both studies also demonstrated that ivermectin 1% was significantly
superior to vehicle in reducing lesion counts, with statistical
significance apparent at week 2 and continuing for the duration of the
study. Trial patients using ivermectin 1% also showed an average
reduction of more than 20 lesions versus a reduction of 12 and 13.4
lesions respectively in the control groups.
In both studies, ivermectin 1% showed comparable tolerability and safety
to the control group vehicle. In Studies 1 and 2 in the ivermectin 1%
cream group, 4.2% and 2.6% respectively of patients that reported
adverse events (AEs) were considered to have AEs related to study
treatment. In the vehicle group, 7.8% and 6.5% of reported AEs were
treatment-related AEs respectively. There were no treatment-related
serious AEs. The most common related AE in Study 1 was sensation of skin
burning (1.8% in ivermectin 1%, 2.6% for vehicle) and the most common
related AEs in Study 2 were pruritus and dry skin (0.7% and 0.9%
Rosacea is a chronic, inflammatory and vascular disorder affecting the
face. Redness, visible blood vessels, bumps, and blemishes typically
appear in the middle of the face (forehead, nose, cheeks) after age 30
in men and women. Rosacea affects an estimated 16 million Americans.
Triggers for the condition may include spicy foods, alcohol, emotional
stress, sun exposure, and hot baths. Because of the physical
manifestation of rosacea on the face, the condition can cause
embarrassment, anxiety and frustration, and can have a negative impact
on the patients' social life. Stinging, burning, sensitivity
of the skin is common, and in some cases, the eyes can become red, dry
and itchy. If left untreated, rosacea may worsen. If people suspect that
they might have rosacea, they should visit their dermatologist or
healthcare provider for diagnosis and treatment.
Galderma is a global company founded in 1981 committed to delivering
innovative medical solutions to meet the dermatological needs of people
throughout their lifetime while serving healthcare professionals around
the world. The company has 33 wholly-owned affiliates with a worldwide
network of distributors and more than 5,000 employees. Galderma's
extensive product portfolio is available in 80 countries and treats a
range of dermatological conditions including: acne, rosacea,
onychomycosis, psoriasis & steroid-responsive dermatoses, pigmentary
disorders, skin cancer and medical solutions for skin senescence.
With approximately 19% of revenues invested each year to discover and
develop new products and access innovative technologies, the company is
one of the world's leading investors in dermatology R&D. Five
state-of-the-art R&D centers and five manufacturing sites are dedicated
to providing a wide range of innovative medical solutions which meet the
highest standards of safety and efficacy.
For more information, please visit: www.GaldermaUSA.com.
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