FDA Approvals and News
Cellulite Treatment Cleared
The FDA has given the green light for Syneron’s VelaSmooth device for the temporary reduction in the appearance of cellulite.
In addition to granting 510(k) pre-marketing clearance for VelaSmooth, the FDA also created a new product code for the device.
Using a combination of technologies, the VelaSmooth incorporates elos (electro-
optical synergy), which is bi-polar radiofrequency and infrared light. Additionally, the VelaSmooth uses tissue mobilization/suction to recontour the skin’s surface. These technologies enable non-invasive treatment by deep heating of the tissue, which in turn causes dermal collagen contraction and redistribution of tissue water. In addition, the VelaSmooth device disrupts the fibrous bands that surround the fat.
Patients will typically need to undergo 8 to 10 30-minute sessions with VelaSmooth to obtain acceptable results.

Home Acne Treatment Device Approved
The FDA has approved a new non-prescription, hand-held, battery-operated device for treating individual mild to moderate acne blemishes.
Approval was based on data from a double-blind, placebo-controlled clinical trial of 51 patients. In the study, 90% of the blemishes treated with the device had either faded or disappeared within 24 hours. The median time to improvement was 12.8 hours for the treatment group vs. 35.6 hours for those receiving placebo. In addition, the median times to resolution were 89.7 hours vs. 140.1 hours, respectively.
The device, which is dubbed the Zeno Zit Zapper, delivers a dose of controlled heat (121 degrees Fahrenheit) but is not considered a laser or a medication.
The technology is thought to work by destroying Propionibacterium acnes and by increasing blood flow to the area surrounding the blemish.
It is most effective when used on an emerging blemish. Treatment time takes 2.5 minutes, and blemishes should be treated two to four times at least 1 hour apart during the first 4 to 12 hours of the blemish’s appearance.
The Zeno device is compatible with other prescription and non-prescription acne treatments.

First-in-Class Antibiotic Approved
The FDA has approved tigecycline (Tygacil), the first antibiotic approved in a new class called glycylcyclines.
This injectable antibiotic has a broad spectrum of antimicrobial activity, including activity against the drug-resistant bacteria methicillin-resistant Staphylococcus aureus (MRSA). Tygacil is indicated for the treatment of complicated skin and skin structure infections in adults, in addition to complicated intra-abdominal infections, and was given an accelerated review by FDA due to the problems with growing antibacterial resistance and a lack of new antibiotics under study/on the market.
This drug can be used at the onset of treatment when the specific bacteria present are not yet known. Also, patients with impaired renal function do not need dosage adjustments with Tygacil, and the drug is dosed every 12 hours.
Tygacil is approved for adults with complicated skin and skin structure infections that are caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus grp. (including S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes, and Bacteroides fragilis.

Expanded Indication for Psoriatic Arthritis Drug
Etanercept (Enbrel), a tumor necrosis factor (TNF) blocker, has received approval from the FDA for an expanded indication for treating psoriatic arthritis. In addition to etanercept’s previous indication to treat signs and symptoms of psoriatic arthritis, which was approved in 2002, the expanded approval means that the drug is now also indicated for the improvement of physical function in patients who have psoriatic arthritis. Etanercept is the first drug to obtain this expanded indication.
Etanercept was shown to inhibit joint destruction from progressing for 2 years in patients who received ongoing therapy.
Including this new expanded indication, etanercept is approved for the following indications for psoriatic arthritis:
1. reducing signs and symptoms of the disease
2. inhibiting the progression of joint destruction of active arthritis associated with psoriatic arthritis
3. improving the physical function in patients who have psoriatic arthritis.
The expanded indication was based on significant results found in patients who were assessed by the disability index of the Health Assessment Questionnaire (HAQ). This test measures patients’ abilities to accomplish routine daily activities. In addition, the expanded indication was based on results from the Medical Outcomes Study Short-Form, another method of assessing the physical impact of psoriatic arthritis on individual patients.
In studies, almost 40% of patients who were taking etanercept had a HAQ score of zero, which indicates that at the 24-week mark they had no functional disability. The Medical Outcomes Study Short-Form also found that patients who were treated with etanercept experienced greater improvement from baseline when compared to placebo.
Etanercept is also approved for treating moderate to severe plaque psoriasis, moderate to severe rheumatoid arthritis and juvenile rheumatoid arthritis as well as ankylosing spondylitis.

Other Drug News
Positive Phase III Data with Oracea
CollaGenex Pharmaceuticals reported up to a 61% reduction in inflammatory lesions in rosacea patients for its drug Oracea during two recent Phase III clinical trials. In the trials, 537 patients were enrolled in 28 U.S. centers. Patients received either Oracea once a day or placebo for 16 weeks.
The highly significant results of the two studies indicated that patients who received Oracea had a 61% and 46% mean reduction in inflammatory lesions, compared with 29% and 20%, respectively, in patients receiving placebo.

Velac Not Approved
Connetics received a non-approvable letter from the FDA regarding its acne treatment 1% clindamycin and 0.025% tretinoin (Velac Gel). FDA noted a concern that a “positive carcinogenicity signal was detected in a TgAC mouse dermal carcinogenicity study,” according to a statement from the company.
In other news, Connetics will resume development of Extina, its formulation of 2% ketoconazole for the treatment of seborrheic dermatitis. The company had received a non-approvable letter from FDA in November 2004 for that product. The reasoning for that decision was insufficient clinical data. Connetics plans to recommence a final Phase III trial
with Extina.

Allergan Will Forge Ahead with Psoriasis Study
After oral tazarotene was rejected for approval by FDA last fall, Allergan has been reviewing options for attempting to seek approval again. The company announced that it will conduct another study of oral tazarotene for the treatment of psoriasis.

Dermatology Foundation Weighs in on TCI Black Box Warnings
During the 2005 DF: Clinical Symposia, the Dermatology Foundation assembled a panel, chaired by James Leyden, M.D., to discuss the FDA Advisory Committee recommendation of a public health advisory and a black box warning regarding cancer for topical calcineurin inhibitors (TCIs) — Protopic and Elidel.
Before the discussion, Dr. Leyden viewed the 8-hour video of the FDA Advisory Panel meeting on the topic. He summarized the meeting for panel members and then summarized what dermatologists already know about cutaneous cancers and lymphomas.
The panel concluded:
• The FDA issued the Public Health Advisory in significantly less time than it normally takes to write and approve such advisories, suggesting the decision had been made before the meeting.
• The FDA panel didn’t include any members who had cutaneous lymphoma expertise, and the sole expert in the audience was not given the opportunity to present his comments.
• The clinical histories and lab reports from the cited cases of cutaneous lymphoma most likely represented pre-existing cutaneous lymphoma.
• The black box warning was unwarranted.
• There should be a new panel of experts in cutaneous lymphoma and other potential adverse reactions to provide a more clinically relevant, balanced evaluation of TCIs.
Dr. Leyden says he is hopeful that the panel’s discussion will help dermatologists make decisions about TCIs based on facts that were presented. n

Experimental Shingle Vaccine Shows Promise
Help may be on the way for the 600,000 or more Americans who are diagnosed with shingles each year. A large clinical trial found that an experimental vaccine against shingles (zoster vaccine) prevented about half the cases of shingles and dramatically reduced its severity and complications in those who had been vaccinated.

Results
The double-blind, multi-center study was conducted over the course of 5 years. Led by the Department of Veterans Affairs (VA) in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and Merck & Co., the study was published in the June 2 issue of The New England Journal of Medicine.
Results were based on a study conducted at 22 sites nationwide, including 16 VA medical centers and six clinical research sites outside the VA system. The study enrolled more than 38,500 men and women aged 60 or older. Half of the participants received a single injection of the zoster vaccine — a live weakened form of varicella-zoster virus (responsible for chickenpox), while the other half received a placebo vaccine.
The zoster vaccine used in this study, manufactured by Merck, is a more potent form of chickenpox vaccine that has been given to children since 1995.
During an average of more than 3 years of follow-up, the vaccine reduced the incidence of shingles by 51% (642 cases of shingles occurred in the placebo group compared to 315 in the vaccinated group). Among those who contracted shingles, the burden of pain and discomfort was 61% lower in the vaccinated group than in the placebo group. And, the vaccine reduced the incidence of post-herpetic neuralgia by two-thirds compared with placebo.

Looking to the Future
The researchers emphasize that the zoster vaccine was tested only as a preventive therapy and is not intended as a treatment for those who already have shingles or post-herpetic neuralgia. Merck submitted a license application to the FDA for the zoster vaccine in April. If approved, the researchers believe it could prevent 250,000 cases of shingles in the United States every year.

In Brief...
A New Dermatology Company…has been founded. Chester Valley Pharmaceuticals, Inc., was formed through a partnership between industry veteran Bob Moccia and GTCR Golder Rauner, LLC, a leading private equity fund based in Chicago. Xavier Yon, former CEO of Galderma, will serve as Chairman of the Board. The company is focused on acquiring, in-licensing and developing branded prescription dermatological products. The company’s first prescription product is Atopiclair, a non-steroidal cream to treat atopic dermatitis.

Dermatologic Cosmetic Laboratories Appoints…Neal B. Schultz, M.D., as its new Senior Vice President and Clinical Medical Director. Dr. Schultz brings his training and 25 years of experience in dermatology to this position. He specializes in cosmetic laser surgery and promotion of skin cancer awareness, early detection, treatment and prevention.

Artes Medical Announced…it has begun qualification runs of ArteFill, a permanent injectable wrinkle filler, at its newly completed commercial cGMP manufacturing facility in San Diego. The company anticipates validation of the manufacturing processes for ArteFill and facilities inspection by the FDA this summer. Artes Medical is preparing for final FDA and commercial approval to occur early fall 2005.

Obagi System Launches…new Web site for patients, physicians and skincare specialists. The site, www.obagi.com, offers a range of tools for patients, including product information, a chat room and “Club Obagi.” For physicians, there is product information with clinical study results, physician success stories, and a password-protected resource center with practice building programs. For other skincare specialists there is information on skin health, a chat room and a password-protected resource center with articles on skin and aging. n