FDA Issues Approvable Letter for MelaFind
The FDA issued an approvable letter for the skin detection device, MelaFind (Mela Sciences), moving the device closer to approval in the US. MelaFind is a computer system that may help dermatologists decide whether to biopsy a lesion suspected to be melanoma, which may in turn reduce the number of invasive biopsies. Approved by European regulators in September and pending certain additional information for US approval, MelaFind may launch in the first quarter of 2012.
According to Mela Sciences, the device is intended for use on clinically atypical pigmented skin lesions with one or more clinical or historical symptoms of melanoma. It uses a special dermoscope to view the skin through a thin layer of alcohol or oil. A digital camera in the probe captures the images and the software sorts between various patterns. According to Reuters Health, Mela will place the systems in physicians' offices for an upfront installation and training fee predicted to be anywhere between $5,000-$10,000, and the company also plans to charge about $50 per patient use.
Boxed Warnings Updated For TNF Inhibitors
Last month, the FDA updated the boxed warnings for the entire class of TNF inhibitors to include the risk of infection from two bacterial pathogens, Legionella and Listeria. In addition, the Warnings and Precautions section of the labels for TNF inhibitors have been revised so that they contain consistent information regarding the risk for serious infections and the associated disease-causing pathogens.
Demographic Patterns in Pediatric Psoriasis
Findings from a new study suggest that pediatric psoriasis is vastly undertreated in certain patient demographics (Arch Dermatol. 2011 Sep 19). Investigators used survey data over a 28-year period to characterize patterns of childhood psoriasis. Of the estimated 3.8 million patient visits for pediatric psoriasis, 93 percent of patients were white and a majority was over the age of eight. Topical corticosteroids were the most commonly prescribed medications. Children zero to nine years old received equally potent corticosteroids as children 10 to 18 years old. Topical calcineurin inhibitors were not among the top 20 most prescribed medications by dermatologists, and systemic agents were not among the top 20 most prescribed medications in any age group. The researchers concluded that treatment guidelines for childhood psoriasis may help reduce treatment variability.
Galderma to Acquire Graceway
Graceway Pharmaceuticals has entered into an agreement for Galderma to acquire substantially all of Graceway's US and Canadian assets, including inventory and intellectual property rights. Galderma will assume the majority of Graceway's contract manufacturing, contract research, and other vendor contracts related to the acquired assets. To implement the transaction, Graceway will seek authority to sell its assets under Section 363 of the United States Bankruptcy Code and through a concurrent receivership proceeding in Canada. Graceway anticipates the sale will be completed by the end of January with minimal disruption to the business.
Medical Honey Found Effective for Wound Care
Medical honey may prove to be an effective option in wound care, according to a new study (Nature, Sept 20). Could dermatologic and cosmetic applications ensue? Researchers evaluated the effects of Medihoney in 20 spinal cord-injured patients with chronic pressure ulcers. After one week of application of Medihoney to the wound site, all swabs were void of bacterial growth, and 18 patients (90 percent) showed complete wound healing after four weeks. Moreover, researchers found no negative effects from the treatment. The researchers concluded that medical honey provides highly valuable efficacy in wound management and infection control and could be included as part of a comprehensive conservative surgical wound-care concept.
Phase II Clinical Trial to Begin for Oral Psoriasis Agent
French regulators have granted authorization for a Phase II clinical trial with oral inecalcitol (Hybrigenics) in patients with moderate-to-severe psoriasis. Inecalcitol is an anti-proliferative vitamin D receptor agonist with non-calcemic activity by oral administration at doses up to four milligrams per day. According to the company, the anti-proliferative activity of oral inecalcitol could be especially useful in patients with moderate-to-severe psoriasis where current vitamin D analogues, although efficacious as local treatments of mild psoriasis, cannot be used on a larger body surface or by oral administration as they can cause hypercalcemia. The study will be a double-blinded and placebo- controlled trial comparing inecalcitol in 40 patients vs. placebo in 20 patients. Inecalcitol will be given orally at four milligrams per day for 16 weeks. Current plans are for the trial to start in the last quarter 2011, and to last about one year.
ASLMS Accepting Submissions
The American Society For Laser Medicine and Surgery (ASLMS) is accepting Scientific Abstract submissions online through Monday, October 17, 2011 for the 2012 Conference to be held April 18- 22 at the Gaylord Palms Resort & Convention Center in Kissimmee, FL. Travel grants are available for students, residents and fellows; Applications online: www.aslmsabstract.org.
Clarification
In the September 2011, p. 50, an editorial revision made the description of optimal timing of Allumera therapy potentially unclear. Please note that: Optimal results require three treatments spaced four weeks apart. For maintenance, Allumera has recommended retreatment every six months.
