FDA Approvals & News
New Dermal Filler Approved
The FDA has approved a new dermal filler that is a hyaluronic acid filler that is non-animal stabilized. Known as Captique, this filler is approved for treating moderate to severe facial wrinkles. Offered by Inamed Corporation and Genzyme Corporation, this filler is the first non-animal stabilized hyaluronic acid offered by Inamed Aesthetics and will complement many of the company’s other dermal filler products such as Zyderm, Zyplast, CosmoDerm and CosmoPlast collagen as well as Hylaform and Hylaform Plus.

New Sclerosant Approved
An abbreviated new drug application for sodium tetradecyl sulfate injection (Sotradecol Injection) for use as a sclerosant in treating varicose veins was cleared by the FDA.
This drug has been found to be effective in treating small, uncomplicated varicose veins of the lower extremities.
According to Bioniche Pharma Group Limited, the manufacturer of the product, there is no other FDA-approved sodium tetradecyl sulfate injection presently available in the United States.
Sotradecol was expected to be available starting last month in two strengths, 1% and 3% and available in 2-ml vials.

SBLA Filed for Psoriatic Arthritis Treatment
The FDA has accepted a Supplemental Biologics Licensee Application (sBLA) for Centocor’s drug infliximab (Remicade), an anti-tumor necrosis factor alpha therapy.
The sBLA was accepted based on results from two, double-blind, placebo-controlled trials, IMPACT and IMPACT 2. The results from these trials were presented this past October at two rheumatology meetings.
In the IMPACT study, 104 patients were randomized to receive 5 mg/kg of infliximab or placebo. The results indicated the following:
• At week 16, 65% of those receiving infliximab therapy achieved ACR 20, a measure of arthritic involvement.
• Of the 38 people who had psoriasis that could be evaluated, 68% achieved a 75% or greater improvement from baseline, which was PASI 75.
• Significant improvements were maintained through 1 year.
In the IMPACT 2 study, which was a Phase III, multi-center, randomized, double-blind, placebo-controlled trial, patients were also treated with 5 mg/kg of infliximab. The results of this trial include the following:
• At week 14, more than half of the patients in the infliximab treatment group experienced significant improvement of both their arthritis and psoriasis — 58% of the infliximab group achieved ACR 20, compared with 11% of the placebo group. Also, nearly 64% of the infliximab group attained a 75% improvement in PASI, compared with 2.3% of the placebo group. These results were achieved even in cases where methotrexate wasn’t used concomitantly and irregardless of the level of joint involvement at baseline.
• At week 24, 27% of patients treated with infliximab had a
70% improvement of arthritis symptoms, compared with only 2% in the placebo group.
• Also at week 24, 39% of patients experienced a
90% improvement in psoriasis, compared with 0% in the placebo group.
Infliximab is the only agent approved in North America for the treatment of both rheumatoid arthritis and Crohn’s disease.

Treatment for Sebaceous Hyperplasia Approved
Candela Corporation has received clearance from the FDA to market the Smoothbeam diode laser as a treatment for sebaceous hyperplasia. The laser’s wavelength is absorbed by water in the skin, and the laser incorporates a dynamic cooling device to help protect the patient’s skin. The indication for sebaceous hyperplasia is the fifth indication for the Smoothbeam. Other indications include facial acne, back acne, acne scars and wrinkles.

FDA Clears Gentlewaves
The FDA cleared the GentleWaves Light Emitting DIode (LED) Photomodulation System for the non-invasive treatment of periorbital wrinkles and rytids. According to Light BioScience, the manufacturer, this is the first LED device to receive marketing approval for a medical claim associated with cosmetic improvement of aging and sun-damaged skin.
Approval was based on the FDA’s review of data from a multi-center clinical study of 54 patients. The study showed that after eight treatments, more than 50% of the patients showed measurable improvement in periorbital wrinkle reduction. Of those with severe wrinkles (category 6 to 8), 94% exhibited measurable improvement.
GentleWaves uses specially coded arrays of LEDs to modulate the activity of living cells. The device delivers very low-intensity, non-thermal light energy to stimulate collagen and reverse the appearance of photoaging.

New Educational Program for Eczema Patients and Caregivers
Novartis Pharmaceuticals Corporation launched Treat Eczema Now, a nationwide public education initiative designed to help patients and physicians overcome barriers to effective long-term control of eczema.
Grammy Award-winning country music singer LeAnn Rimes, who was diagnosed with eczema when she was only 2 years old, is leading the charge as the spokesperson for this educational initiative. This is the first time she has spoken publicly about her experience with eczema.
According to The Eczema Survival Guide, a comprehensive new report developed
by the National Eczema Association for Science and Education (NEASE) in
conjunction with Novartis Pharmaceuticals, the majority of physicians (91%) believe prescription medications are effective in managing eczema. In contrast to this finding, 64% of eczema patients say they are dissatisfied with their prescription medication.
Through the Treat Eczema Now initiative, Novartis hopes to help bridge the patient/physician communication gap around effective disease management, with educational tools such as the Eczema Survival Guide, which patients can access at www.TreatEczemaNow.com or by calling toll-free at (877) MY-ECZEMA.
The Eczema Survival Guide is a comprehensive resource for eczema patients, including information on the epidemiology of the disease, the latest insights on treatment paradigms, as well as patient perspectives on the physical and emotional toll of the disease.
The goal of the guide is to help facilitate an effective dialogue between patients and their doctors so they can work together to identify the most appropriate treatment strategy.
Patients can download the guide at www.TreatEczemaNow.com. Also through this site, patients can access information about eczema and treatments, as well as learn about tips for coping with the disease. In addition, patients are welcomed to learn more about LeAnn Rimes’ struggle with her mild to moderate eczema.

New Rosacea Grading System
The National Rosacea Society has introduced the first standard grading system for the study and clinical assessment of rosacea, which was developed by a consensus committee and review panel of 17 rosacea experts. The new guidelines were published recently in the Journal of the American Academy of Dermatology.
The new system provides grading criteria and guidelines for the primary and secondary features of rosacea, as defined in the standard classification system, and establishes a global assessment by standard subtype that includes the physicians’ scoring of severity and the patient’s own evaluation.
The primary signs and symptoms of rosacea are transient erythema, nontransient erythema, papules and pustules, and telangiectasia. The grading system recommends that the physician rates these signs as absent, mild, moderate or severe. The physician should similarly rate the secondary signs and symptoms, which include ocular manifestations, burning or stinging, plaques, dry appearance and phymatous changes. Doctors should also note whether edema and peripheral location are present or absent.
The system also calls for a global assessment of the patient’s condition into the four standard subtypes outlined in the standard classification system. These include:
• Subtype 1 — erythematotelangiectatic rosacea, characterized by flushing, persistent central facial erythema, and in some cases telangiectasia
• Subtype 2 — papulopustular rosacea, characterized by persistent erythema with papules or pustules
• Subtype 3 — phymatous rosacea, characterized by thickening skin and enlargement, most commonly of the nose
• Subtype 4 — ocular rosacea, which may include eye irritation, blepharitis, watery or bloodshot appearance, and other ocular manifestations.

In Brief...
Barrier Therapeutics announced…positive results from its confirmatory Phase III clinical trial for Sebazole, a topical 2% ketoconazole formulated in a waterless gel for once-daily application, for the treatment of seborrheic dermatitis. The company plans to file an NDA to the FDA for Sebazole by mid-2005. This study, a double-blind, vehicle-controlled study of once-a-day Sebazole treatment compared to the vehicle alone, enrolled 459 patients at 24 U.S. centers. Results found 25.8% of the Sebazole group reached the primary endpoint, compared to 13.9% of the vehicle group.

Consumer Reports launched… a new prescription drug comparison Web site, Best Buy Drugs Web site, 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.

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.