Pipeline Previews

April 2013 | Volume 12 | Issue 4 | Feature | 494 | Copyright © 2013

Abstract

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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Amino Acid Derivative forDeep Lines and Wrinkles

NeoStrata Company, Inc, has announced the launch of SKIN ACTIVE Line Lift featuring breakthrough professional-strength Aminofil, a novel tyrosine amino acid derivative (N-acetyl tyrosinamide) that delivers a volumizing effect in the deep skin matrix to visibly reduce deep facial lines and wrinkles. New 2-step Line Lift joins the Company’s SKIN ACTIVE line of advanced comprehensive antiaging skin care products available exclusively through professional dermatology offices.

The SKIN ACTIVE Line Lift duo is a 2-step treatment. Applied together twice daily, it targets deep expression lines, such as glabellar lines, crow’s feet, lip lines, and nasolabial lines. Line Lift contains NeoStrata’s proprietary SynerG 13.0 formulations featuring Aminofil, NeoCitriate, and NeoGlucosamine®. The company purports that these ingredients work together to help build glycosaminoglycans, including hyaluronic acid and collagen to volumize the deep skin matrix.

A progressive series of studies was conducted with Aminofil including a 16-week, double-blind, vehicle-controlled clinical study of SKIN ACTIVE Line Lift. In the study, Line Lift outperformed the vehicle with statistical significance (P<.05) on all clinically graded parameters, which included crow’s feet, nasolabial, glabellar, and undereye areas. Doctors and patients observed visible improvements in targeted deep lines and wrinkles as early as 4 weeks with continued improvement through week 16. Patients observed that these lines and wrinkles were less noticeable, appeared to be lifted, and that skin looked and felt firmer.

The study included women with moderate photodamage and rhytides on at least one of the following: glabellar area, nasolabial folds, and/or crow’s feet (n=70). The subjects, Caucasian women aged 40 to 65 years, applied steps 1 and 2 or their vehicles twice daily after cleansing for 16 weeks. Nonmedicated cleanser was used and daytime moisturizer SPF 20 and night moisturizer were standardized.

BTG Submits Varicose Vein Treatment to FDA for Review

BTG International submitted a new drug application to the FDA for Varisolve, polidocanol endovenous microfoam (PEM) a microfoam injection that treats varicose veins through slerotherapy. The Varisolve microfoam contains gas-filled bubbles that are designed to chemically scar the inner tissue of varicose veins, but which are not deactivated and diluted by blood as quickly as liquid treatments.

Results of the US phase 3 trial of PEM in 2012 showed “a high degree of statistical significance,” according to BTG. In an earlier European phase 3 trial, 90% of patients exhibited symptoms at 3 months and less than 10% at 1 year. Also, unlike surgical methods, PEM treatment allowed for simpler application and recovery.

Stiefel’s Alternate Fixed-Dose Duac® (clindamycin 1% and benzoyl peroxide 3%) Closer to Approval in Europe

Stiefel has announced that it has received positive recommendation by MHRA (Medicine and Healthcare products Regulatory Agency, UK) for the approval of a new fixed-dose combination of Duac® (clindamycin 1% and benzoyl peroxide 3%) gel for the topical treatment of mild to moderate acne vulgaris, particularly inflammatory lesions, in adults and adolescents aged 12 years and older.This new fixed-dose combination of Duac is an extension to the parent product Duac (clindamycin 1% and benzoyl peroxide 5%), which is currently approved and available in more than 50 countries around the world, including the United States, Europe, Asia, Australia, Latin America, and Canada.

The regulator’s recommendation positively concludes the European regulatory procedure and instigates the process of granting national licences to make it available in 15 European countries.

This recommendation is based on review of the data on quality, safety, and efficacy of this new fixed-dose combination. The safety and efficacy was evaluated in a phase 3 study of 1,319 patients with mild to moderate acne. The study compared the new fixed-dose combination with each of the individual components (clindamycin 1% or benzoyl peroxide 3% or vehicle) applied once daily for 12 weeks.

This new fixed-dose combination of Duac (clindamycin 1% and benzoyl peroxide 3%) was first approved in Canada in April 2012, but is not approved or licensed in the United States.

FDA Approves Galderma Laboratories’ Epiduo® Acne Treatment

Galderma Laboratories, L.P., has announced that the FDA has approved Epiduo® (adapalene 0.1%/benzoyl peroxide 2.5%) Gel to

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