January 2014 | Volume 13 | Issue 1 | Feature | 93 | 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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FDA Approves Anti-Fungal Luzu® Cream, 1%
Valeant Pharmaceuticals North America LLC, has received notice that the New Drug Application for Luzu® (luliconazole) Cream, 1% has been approved by the FDA. Luzu® Cream, 1% is indicated for the topical treatment interdigital tinea pedis, tinea cruris, and tinea corporis, caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients 18 years of age and older. These are very common skin diseases caused predominantly by dermatophyte fungi.
Luzu® (luliconazole) Cream, 1% is the first topical azole antifungal agent approved to treat tinea cruris and tinea corporis with a one-week, once-daily treatment regimen. All other approved treatments require two weeks of treatment. Interdigital tinea pedis is approved with a two-week, once-daily treatment. US approval is the first regulatory approval in North America. Luliconazole has been approved in Japan since 2005.
Luzu® has been extensively studied in the US, with three positive pivotal studies that were the basis for approval. These studies were conducted in 679 subjects with either tinea pedis or tinea cruris.
For the two pivotal studies in tinea pedis with a treatment duration of two weeks, the primary endpoint was stringently defined as complete clearance 4-weeks post-treatment. In Study 1, 26% of subjects treated with Luzu® were completely cleared, compared to only 2% of subjects treated with vehicle. In Study 2, 14% of subjects treated with Luzu® were completely cleared, compared to only 3% of subjects treated with vehicle.
For the pivotal study in tinea cruris, complete clearance was assessed 3-weeks post-treatment. After 1 week of treatment, 21% of subjects treated with Luzu® were completely cleared, compared to only 4% of subjects treated with vehicle.
New Turbo Safety Needle for the Eclipse MicroPen™
Eclipse Aesthetics, LLC, makers of the popular Eclipse MicroPen™ has launched its new fluid resistant vented Turbo Safety Needle. The Eclipse MicroPen™ is a surgical grade micro-needling device designed for the improvement of stretch marks, acne scars, fine lines and wrinkles.
Micro-needling is a clinically proven, non-ablative skin treatment that allows for treatment to deeper parts of the skin while leaving much of the top layers intact for faster healing. Through Controlled Induction Therapy (CIT) of the skin’s self-repair process, Eclipse MicroPen™ creates thousands of precise and purposed micro injuries under the top layer of the skin within seconds.
All of these tiny controlled micro injuries trigger new collagen and tissue fibers to the treated area, as well as directing new blood flow to the skin. Additionally, topical treatments have difficulty penetrating the lower levels of skin and the micro-needling allows temporary penetration for topical treatments. The treatment results in the reduction of wrinkles, fine lines and scarring while minimally damaging the top layer of the skin.
Depending on the size of the area treated, number of areas and the severity of damage on the skin, the procedure typically takes 15-30 minutes. Patients see improvements in scars, wrinkles, skin discoloration, stretch marks, and large pores often after one treatment. More importantly, there is little or no downtime following the procedure with the Eclipse MicroPen™.
Eclipse touts certain features of the MicroPen™, including its needle cartridge housing that eliminates cross-contamination risk by blocking migration of fluids; a vented port to reduce vacuum pressure which could contribute to the formation of broken capillaries; and 12 sterile 32-gauge precision sharp surgical grade needles for rapid healing and minimized discomfort results.
Apremilast Releases Positive Study Results at ACR 2013
Positive results in three separate pivotal phase III trials for psoriatic arthritis and a favorable phase II study in Behçet’s syndrome involving the novel oral phosphodiesterase-4 inhibitor apremilast were released at the annual meeting of the American College of Rheumatology by Dr. Alvin F. Wells. Dr. Wells reported that apremilast resulted in clinically meaningful improvement in psoriatic arthritis symptoms, physical function, and associated skin psoriasis at 16 weeks in the PALACE 4 trial. Moreover, the improvement remained durable through 52 weeks in the phase III clinical trial.
PALACE 4 compared apremilast against placebo as a first-line treatment in 527 patients with psoriatic arthritis not previously treated with a disease-modifying antirheumatic drug. This was a population with active disease: a mean baseline 11 swollen and 20 tender joints; a Health Assessment Questionnaire Disability Index score averaging 1.07; and a 50% prevalence of dactylitis, with a mean severity score of 2.0. Sixty-five percent of patients had enthesitis, with a median Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) of 3.0. Participants had a mean 16-year history of psoriasis and a 3.4-year duration of psoriatic arthritis.
The primary study endpoint was attainment of an American College of Rheumatology 20% improvement (ACR20) response at 16 weeks. This was achieved in 29.2% of patients randomized