FDA Approvals & News
New Psoriasis Treatment
A Class I corticosteroid cream has been approved by the FDA to treat plaque-type psoriasis affecting up to 10% of body surface area. Fluocinonide 0.1% cream (Vanos) is indicated for once or twice daily application.
In double-blind, randomized clinical trials with this drug, participants applied fluocinonide 0.1% twice a day for 2 weeks. In 31% of cases, patients’ lesions were cleared or almost cleared with this therapy. The most common adverse events experienced were headache and burning at the application site.
Vanos will be available in 30-gram and 60-gram tubes, and Medicis expects to begin making this therapy available to dermatologists beginning next month.

Skin Rejuvenation Device Approved
Candela recently received approval from the FDA for its Ellipse I2PL system, an intense pulsed light device that has integrated the company’s I2PL patented technology.
The device is indicated for treatment of vascular and pigmented abnormalities. The Ellipse I2PL was unveiled in late February at the American Academy of Dermatology meeting in New Orleans.

Generic version of Sporanox
The first generic of itraconazole (Sporanox) has now been launched. Eon received approval for its abbreviated new drug application of the drug last May but could not launch the drug until now because of a temporary restraining order issued by Janssen, which was part of a patent infringement lawsuit.

Early-Stage Trials with Potential Hookworm Vaccine
The FDA has approved a human hookworm vaccine for Phase I safety trials. This vaccine is the first of its kind for hookworm, which affects an estimated 740 million people, especially in poverty-stricken areas of the tropics and subtropics. The project is being sponsored by the Albert B. Sabin Vaccine Institute with funding from the Bill and Melinda Gates Foundation. The research will be conducted at George Washington University Medical Center.

New Web Sites
The Dermatology Nurses’ Association launched an on-line Career Center to help match qualified dermatology nurses with employers. The Center is available on the Association’s Web site, www.dnanurse.org. The Career Center is a participating member of the HEALTHeCAREERS Network, an online pool of more than 50 healthcare association career centers.

GlaxoSmithKline introduced a new Web site for healthcare professionals in the area of dermatology. The site, www.derm-professional.com, offers clinical and prescribing information about GlaxoSmithKline Consumer Healthcare dermatology products, including alclometasone dipropionate (Aclovate), fluticasone propionate (Cutivate) and oxiconazole nitrate (Oxistat). Through this site, you can access study results on these products, dosage and administrations recommendations, safety profiles and guidelines for treating specialty populations with these products.
Visitors to the site can request product samples, access relevant links, browse educational materials and expand knowledge through visually engaging mechanism of action multi-media clips.

Consumer Reports launched a new prescription drug comparison Web site, Best Buy Drugs, that will allow patients free access to compare the cost and effectiveness of a variety of commonly prescribed drugs. The Web site can be found at www.crbestbuydrugs.org.

The National Patient Safety Foundation announced the launch of an interactive Web site that contains three education modules. The site was developed under a grant from the Agency for Healthcare Research and Quality. The physician’s module (www.npsf.org/html/mcw/physicians.html) offers continuing medical education credits, and the nurse’s module (www.npsf.org/html/mcw/nurses.html) offers continuing education units. Both are offered through the Medical College of Wisconsin. The patient’s module (www.npsf.org/html/patients_web.html) provides information on medication safety, pediatric care, medical device safety and anesthesia patient safety.

In Brief...
TaroPharma…is now marketing and distributing hydroquinone USP 4% (Lustra) and hydroquinone USP 4% and sunscreen (Lustra-AF) through a licensing agreement with Medicis Pharmaceutical Corporation. Indicated for the gradual treatment of UV-induced dyschromia and discoloration that have resulted from oral contraceptive use, pregnancy, hormone replacement therapy or skin trauma, these medications will be supplied in 2-oz tubes.

PhotoMedex Inc. and Procyte Corporation…announced that the companies entered into a definitive merger agreement. PhotoMedex will acquire ProCyte in a stock-for-stock transaction valued at approximately $24.4 million. This acquisition will allow PhotoMedex to expand its presence in dermatology. ProCyte develops and markets therapeutic and daily-use skincare and procedure-based products to dermatologists. Many of ProCyte’s products incorporate the company’s patented GHK Copper Peptide technology. The products are used to improve healing after procedures, such as laser resurfacing, laser hair removal and microdermabrasion, and also to reduce hyperpigmentation, fine lines and wrinkles.

Sirius Laboratories Announced…the appointment of Garry R. Barnes as the company’s new President and Chief Executive Operating Officer. Former President, Frank Pollard, has been appointed to Vice Chairman. Mr. Barnes will be responsible for creating a new dynamic for Sirius Laboratories, focusing on the company’s future growth and aligning the company’s capabilities with industry demand. Mr. Pollard will develop new additions to the company’s brands and will restructure the current roster of products.