July 2014 | Volume 13 | Issue 7 | Features | 877 | Copyright © July 2014
Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department
may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In
addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.
Galderma Canada Inc., has announced that ONRELTEA™ topical
gel (Brimonidine gel 0.33%) has been approved by Health
Canada and is now available for Canadian patients 18 and older
to treat the facial erythema (redness) of rosacea. ONRELTEA is
the first and only Health Canada-approved topical prescription
specifically designed to treat the facial redness of rosacea.
Galderma claims that ONRELTEA starts to relieve facial redness
within 30 minutes with maximum effect at about 3 hours.
Galderma states that ONRELTEA may work by constricting the
dilated facial blood vessels to reduce the redness of rosacea.
The approval of ONRELTEA was based on data collected from
more than 550 patients enrolled in two phase 3 clinical studies
of one-month duration. The results from both studies showed
that adults who used ONRELTEA demonstrated significantly
greater improvement in the facial redness of rosacea than vehicle
gel. A long-term study was also conducted involving 276
subjects who used ONRELTEA for up to 12-months.
NeoStrata Company, Inc., has released a new skin renewal treatment
called Exuviance Triple Microdermabrasion. NeoStrata
states that Exuviance Triple Microdermabrasion employs a
unique blend of physical, chemical, and enzymatic rejuvenators
for instant, dramatic skin resurfacing results.
The potent exfoliator also contains Papaya Enzymes along with
10% Glycolic Acid to help dissolve impurities, unclog congested
pores, loosen dead skin cells, and resurface dull and dry patches.
NeoStrata also claims that the Exuviance Triple Microdermabrasion
stimulates cell renewal, encouraging skin to renew
itself. With regular use, once or twice a week, NeoStrata assures
customers that they will notice clearer, brighter, more
even toned skin and will even see increased performance of
other skincare products.
Exuviance Triple Microdermabrasion, $72 will be available in
August 2014 at Exuviance.com, ULTA, and select prestige beauty
FDA Approval Of Jublia
Valeant Pharmaceuticals International, Inc. has announced
FDA approval of the New Drug Application (NDA) for Jublia® (efinaconazole 10% topical solution), the first topical triazole
antifungal agent developed for distal lateral subungual onychomycosis
Valeant explains that Jublia® is applied daily to the nail with a
novel bottle that has a built-in flow-through brush applicator. It
dries quickly and there is no need to remove excess product.
There are no concerns for systemic side effects such as drugdrug
interactions or acute liver injury.
Valeant states that Jublia® has been extensively studied prior
to its approval, pointing specifically to the two positive pivotal
studies that were the basis for approval that were published
last year in the Journal of the American Academy of Dermatology. These international studies were conducted in 1,655
subjects with onychomycosis, including subjects in Canada.
For the pivotal studies, the primary endpoint was complete
cure at Week 52, which required that the target nail show no
clinical involvement and no evidence of fungus present by both
KOH testing and a negative fungal culture. In Study 1, 17.8% of
subjects treated with Jublia® were completely cured, compared
to only 3.3% of subjects treated with vehicle. In Study 2, 15.2%
of subjects treated with Jublia® were completely cured, compared
to only 5.5% of subjects treated with vehicle.
Adverse events that were reported were generally mild and
transient and were similar between subjects treated with Jublia ® and vehicle. The most commonly reported adverse events
in patients treated with Jublia® were application site dermatitis
and application site vesicles.
Phase III Data Shows Secukinumab (AIN457)
Novartis has announced results from the Phase III FEATURE and
JUNCTURE studies showing secukinumab (AIN457), a selective
interleukin-17A (IL-17A) inhibitor, met both co-primary endpoints
at Week 12 based on Psoriasis Area and Severity Index (PASI)