FDA Approvals and NewsRapid MRSA Detection Test ClearedA new rapid-detection test for confirming the presence of methicillin-resistant Staphylococcus aureus (MRSA) has been cleared by the FDA. Manufactured by Cepheid, a broad-based molecular diagnostics company, the Xpert MRSA test can confirm the presence of MRSA in just over 1 hour. MRSA is resistant to antibiotics including methicillin, oxacillin, penicillin and amoxicillin. Bottles of Liquid Grifulvin RecalledThe treatment for ringworm and other fungal infections, griseofulvin (Grifulvin V) has been recalled. The recall concerns only glass bottles of griseofulvin oral suspension (liquid) in microsize 125 mg/5 ml. The voluntary recall was enacted because of two reports of glass fragments found in bottles of the liquid formulation. Ortho Dermatological, Division of Ortho-McNeil Pharmaceutical, Inc., the manufacturer of Grifulvin V and griseofulvin oral suspension (which bears the label of Patriot Pharmaceuticals, L.L.C.) are conducting the recall. The reports of glass fragments are believed to have resulted from some bottles that broke during shipping and handling. However, there is no evidence of adverse events from the reported glass fragments in broken bottles.The lots were shipped to distributors in the United States only between August 23, 2005, and March 14, 2007. To check lot numbers log onto www.aboutgrifulvin.com. Other Drug News Study of Tinea Versicolor Drug PromisingBarrier Therapeutics had positive results from its Phase 2b dose ranging study for its novel oral antifungal product candidate Pramiconazole (previously known as Azoline), a potential short-course treatment for acute skin and mucosal fungal infections. Pramiconazole met the primary endpoint of effectively treating tinea (pityriasis) versicolor and also the secondary endpoints of complete cure, mycological cure and investigators’ global assessment achieved statistical significance.The randomized, double-blind, placebo-controlled dose ranging study enrolled 147 patients in six treatment groups. The study results demonstrated a positive linear dose response (p<0.001) for the primary endpoint “effectively treated” at day 28. Effectively treated was defined as significant reduction in disease signs and symptoms, including redness, scaling and itching, and complete mycological cure. Response rates for the primary endpoint ranged from 35% for the lowest dose to 85% for the highest dose as compared to 16% for placebo.The drug was well tolerated with no reports of drug-related serious adverse events. Pramiconazole is also being developed as well as a potential once-weekly treatment for chronic fungal infections such as onychomycosis.Are Antibiotics Always Necessary to Treat Skin Abscesses?According to an online article in Annals of Emergency Medicine, most abscesses can be treated successfully without antibiotics even in an environment heavily contaminated with methicillin-resistant Staphylococcus aureus (MRSA). The article, “Are Antibiotics Necessary After Incision and Drainage of a Cutaneous Abscess?” was based on a 30-year review of the medical literature. It concluded that except in cases where cellulitis is present, abscesses treated by simple incision and drainage heal just as well as those treated with incision, drainage and antibiotics. Stressing the importance of this finding in view of widespread concern about antibiotic misuse and antibiotic resistance, study author Worth W. Everett, M.D., of the University of Pennsylvania Department of Emergency Medicine, said, “The current research simply does not support the routine practice of prescribing antibiotics following incision and drainage of simple abscesses. This could change how we treat this very common emergency department complaint for both adults and children.” New Study Reveals Misdiagnosis of Malignant Moles is on the RiseA survey of American Society for Dermatologic Surgery (ASDS) members reveals that 90% of the dermasurgeons have seen patients whose skin cancer was misdiagnosed or overlooked. To raise awareness among consumers, the ASDS is urging the public to monitor moles and pimples with the added warning that improper treatment or removal by an untrained practitioner can be deadly. Scientists Implicate Gene in Vitiligo and Other Autoimmune DiseasesScientists supported by the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases have discovered a connection between a specific gene, NALP1, and the inflammatory skin condition vitiligo, as well as a possible host of autoimmune diseases. The researchers began a search for genes involved in vitiligo almost a decade ago. In cooperation with the Vitiligo Society in the United Kingdom, they circulated a questionnaire asking society members about their own vitiligo and whether other family members were affected; they also asked about other autoimmune diseases. The responses they received showed that vitiligo was “very highly associated” with a number of other autoimmune diseases, mostly thyroid disease, but also pernicious anemia, rheumatoid arthritis, psoriasis, lupus, Addison’s disease, and adult-onset autoimmune diabetes. That finding prompted the researchers to study families with multiple affected members and to look for similarities in genes among those who were affected. By searching the genome, they discovered the gene NALP1 that was the key to predisposing people to vitiligo and other autoimmune diseases, particularly autoimmune thyroid disease. Richard Spritz, M.D., director of the Human Medical Genetics Program at the University of Colorado at Denver and Health Sciences Center and lead investigator for the study says the identified gene controls part of the innate immune system and is likely a receptor for bacterial or viral signals. “We don’t know what these signals are, but now that we know what the gene is, we can use that knowledge to search for the signals that trigger autoimmune disease.”The most immediate application of this research might be for the disease that began the research — vitiligo, which is typically treated with ultraviolet (UV) light to stimulate skin repigmentation. A currently available medication approved for treating rheumatoid arthritis is known to block an inflammatory pathway thought to be controlled by NALP1. Intrigued by the possibility of combining a drug with UV light to improve vitiligo treatment, Dr. Spritz is now interested in finding more about how the medication might affect people with vitiligo. nEffective Treatment for Blood Disorder Often Seen First by DermatologistsA hereditary blood disorder that is often seen by dermatologists because it manifests as attacks of extreme skin swelling can be treated effectively with C1-inhibitor concentrate (C1-INH), which is investigational in the United States but has been used for more than 20 years in Europe under the name Berinert-P.Hereditary angioedema (HAE), an inherited disorder caused by a deficiency of the plasma-based protein CH-INH inhibitor, results in attacks of extreme swelling of the hands and feet, face, abdomen and/or larynx. The study compared how quickly these symptoms were relieved using C1-INH concentrate as treatment versus no treatment at all and looked at patients over a period of almost 30 years. Study DesignFindings were based on a retrospective clinical analysis of 1,828 swelling attacks in 43 HAE patients over a period of almost 30 years who were treated with 500 units (1,445 attacks) or 1,000 units (383 attacks) of C1-inhibitor concentrate. The time to relief, the duration of the swelling, and the severity of symptoms were documented during personal interviews and compared with 6,625 untreated attacks in the same patients. The skin swelling attacks affected the face (440 attacks), hands and arms (721 attacks), feet and legs (516 attacks), genitals (122 attacks), and the trunk (29 attacks). Key FindingsThe mean time to relief of symptoms was 1.3 hours +/- 1.4 hours in all treated attacks versus 60 hours +/- 26.4 hours in all untreated attacks. The mean duration of the attacks was shortened from 88 hours (SD 40.8 hours) (untreated attacks) to 40.8 hours (SD +/- 33.6 hours) (treated attacks). All patients responded to treatment. In 24 attacks of four patients, the course of the treated attacks was not shortened, but symptoms were milder compared to untreated attacks. C1-inhibitor concentrate was more effective when injected early in the attacks compared to late injections. There were no drug-related side effects.According to the study, relief of symptoms occurred in all treated attacks after 1.3 hours (+/- 1.4 hours) in the mean after receiving C1-INH concentrate. In all untreated attacks, the mean time to relief of symptoms was 60 hours (+/- 26.4). In BriefSYNERON MEDICAL LTD. AND OBAGI MEDICAL PRODUCTS, INC. ARE PLANNING… a multi-center clinical study with Obagi’s newly developed Nu-Derm Condition and Enhance skin care systems prior to or following elos treatments to measure improvement in overall patient outcome for the treatment of fine lines, photodamage and hyperpigmented skin attributable to the combination therapy. As part of the study, doctors who are actively performing Syneron elos procedures will begin evaluating Obagi’s newly developed Nu-Derm Condition and Enhance skincare systems prior to or following elos treatments to measure improvement in overall patient outcome for the treatment of fine lines, photodamage and hyperpigmented skin attributable to the combination therapy.SYNERON AND Procter & Gamble ANNOUNCED… an exclusive joint development and supply agreement for the commercialization of patented, elos-based, home-use devices and compositions for the enhancement of skin appearance through the treatment of fine lines, wrinkles, photodamage and cellulite. P&G selected elos technology as its preferred, non-invasive, energy-based solution for home-use aesthetic treatments in this field. Under the terms of the agreement, Syneron will lead the research, development and manufacturing while P&G will focus on the development of the compositions, marketing, and distribution. The home-use devices will be marketed under the P&G family of skincare products and will be co-branded with Syneron's elos technology. P&G and Syneron plan further collaboration that could lead to commercializing additional products in the future.IPSEN AND GALDERMA ANNOUNCED… that they have entered into a partnership for the development, promotion and distribution of Ipsen’s botulinum toxin type A for use in aesthetic medicine indications in Europe and certain other territories. Under the terms of this agreement, Ipsen granted Galderma exclusive rights to develop, promote and distribute a specific formulation for the aesthetic medicine indications of its botulinum toxin type A product in the European Union, Russia and certain territories of the Middle East and Eastern Europe. JSJ PHARMACEUTICALS ANNOUNCED… a multi-year agreement under which it has assumed from Valeant Pharmaceuticals International the sales, marketing, and educational responsibilities for Oxsoralen-Ultra for the treatment of severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy.CAMPBELL-EWALD HEALTH ANALYSIS SUGGESTS… nearly half of the U.S. population does not fully understand the information on drug Web sites that target consumers. This, says the healthcare marketing firm, is because comprehending the information on the average drug Web site requires 12 years of education. In addition, more than three-quarters of the Web sites do not offer information in Spanish, and only half were designed using standard guidelines to improve the usability and accessibility of Web sites, the study showed.PACIFIC BIOSCIENCE LABORATORIES INC. ANNOUNCED… new financing and the addition of two new board of directors members. The new board members named by the maker of the Clarisonic Skin Care Brush were Jane McKellar, CEO of Stila Corporation, a global prestige cosmetics company, and Joel Kanter, President of Windy City, Inc., a privately held investment firm. The new financing — a $10.5 million private equity placement — will be allocated to fund expansion plans, accelerating Clarisonic’s rollout in the marketplace and developing new products.THE AMERICAN ACADEMY OF DERMATOLOGY ELECTS… new officers and board members including President-Elect David M. Pariser, M.D., and Vice President-Elect Evan R. Farmer, M.D. Board electees include Lisa A. Garner, M.D.; David J. Goldberg, M.D., J.D.; Victor J. Marks, M.D., and Elise A. Olsen, M.D. Their 4-year terms will begin at the conclusion of the Academy’s 66th Annual Meeting in February 2008.THE WOMEN'S DERMATOLOGIC SOCIETY IN PHOENIX… reached out to this at-risk community by presenting its “Play Safe in the Sun” program to the Ladies Professional Golf Association (LPGA) Safeway International at Superstition for the ninth consecutive year. The campaign teaches people of all skin types to properly and regularly apply a golf-ball-size amount of broad-spectrum sunscreen (UVA and UVB protection) with an SPF of 30 or higher, which should be re-applied every nine holes, or every 2 hours.