Pipeline Previews

January 2013 | Volume 12 | Issue 1 | Feature | 128 | 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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FDA Approves Generic Betamethasone Valerate Foam 0.12%

Perrigo Company has announced that its partner, Cobrek Pharmaceuticals, has received FDA approval of an Abbreviated New Drug Application for betamethasone valerate foam 0.12%, the generic equivalent of Luxiq® Foam. Perrigo has manufactured the product and is preparing to commence commercial shipments on January 15, 2013, consistent with the date certain launch settlement. Cobrek was first to file, making the product eligible for 180 days of marketing exclusivity.

Betamethasone valerate foam 0.12% is indicated for the relief of corticosteroid-responsive skin conditions of the scalp (scalp psoriasis).

Ranbaxy Launches Absorica™ (Isotretinoin) Capsules

Ranbaxy Laboratories, Inc, has announced the launch of Absorica™ (Isotretinoin) Capsules in the US health care market. Absorica is indicated for the treatment of severe recalcitrant nodular acne in patients 12 years and older.

Typically, isotretinoin is taken with a high-fat meal to take advatange of its high lipophilicity and improve oral absorption. Absorica, however, is formulated using Ranbaxy’s patented Lidose® technology, which allows it to be taken at any time. Absorica is not interchangeable and not substitutable with generic products of Accutane.

Isotretinoin is marketed under the the iPLEDGE program, which requires prescribers to be registered and activated with the iPLEDGE program; limits prescriptions of isotretinoin to registered patients who meet all the requirements of iPLEDGE; limits dispension of isotretinoin to pharmacies registered and activated with iPLEDGE; and limits receipt of isotrentinoin by parmacies to isotretinoin from wholesalers registered with iPLEDGE.

Sandoz Launches Generic Version of TOPICORT® 0.25% Ointment

Sandoz has announced the FDA approval and US launch of its desoximetasone ointment USP, 0.25%, a generic equivalent of TOPICORT 0.25% Ointment.

Desoximetasone ointment is a topical corticosteroid used to relieve redness, swelling, and itching that result from various inflammatory skin diseases. Sandoz is marketing desoximetasone ointment in the 0.25% strength, the same strength that is marketed as TOPICORT 0.25% Ointment.

Quick-Release Medical Tape That Minimizes Neonatal Skin Injury

A research team from Brigham and Women’s Hospital (BWH), led by Jeffrey Karp PhD, BWH Division of Biomedical Engineering, Department of Medicine, senior study author in collaboration with the Institute for Pediatric Innovation, has invented a quick-release tape that has the strong adhesion properties of commercial medical tape but eliminates the danger of skin tissue tearing upon removal from neonatal skin.

The study detailing the tape design will be electronically published in the Proceedings of the National Academy of Sciences. The research was conducted in collaboration with Robert Langer PhD at the Massachusetts Institute of Technology.

The tape, which achieves strong adhesion when securing medical devices to skin, but could also easily peel off safely, utilizes a 3-layer design.

“Current adhesive tapes that contain backing and adhesive layers are tailored to fracture at the adhesive-skin interface. With adults, the adhesive fails, leaving small remnants of adhesive on the skin, while with fragile neonate skin, the fracture is more likely to occur in the skin, causing significant damage,” said Karp. “Our approach transitions the fracture zone away from the skin to the adhesive-backing interface, thus completely preventing any harm during removal.”

The approach incorporates an anisotropic adhesive interface between the backing and adhesive layers. The anisotropic properties of this middle layer means that it has different physical properties dependent on direction.

The researchers employed laser etching and a release liner to create the anisotropic interface resulting in a medical tape with high shear strength (for strong adhesion) and low peel force (for safe, quick removal). Once the backing is peeled off, any remaining adhesive left on the skin can safely be rolled off with a finger using a “push and roll” technique.

Certolizumab Pegol and Psoriatic Arthritis

RAPID™-PsA study is the first double-blind, placebo-controlled, phase 3 study of a biologic treatment in psoriatic arthritis (PsA) to include patients with and without prior anti–tumor necrosis factor (TNF) exposure. Data presented from this phase 3 study showed that compared with placebo, certolizumab pegol provided improvements in the signs and


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