July 2014 | Volume 13 | Issue 7 | Feature | 877 | Copyright © 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.
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ONRELTEA™ Topical Gel (Brimonidine gel 0.33%)
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.
Exuviance® Launches Triple Microdermabrasion
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 retailers nationwide.
FDA Approval Of Jublia® for the Treatment of Onychomycosis
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 (DLSO).
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) Improves Psoriasis
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)