Biafine Emulsion Is Now Packaged in the U.S. for Dermal Wounds and Radiodermatitis

First Product That Impacts All Three Phases of Healing Process by Attracting Macrophage Cells to Wound Site

Medix Pharmaceuticals Americas, Inc. (MPA, Washington, DC) announced that its wound management emulsion, Biafine, is now separately packaged in the United States specifically for two applications: Biafine Wound Dressing Emulsion (WDE) for the management of dermal wounds and burns and Biafine Radiodermatitis Emulsion (RE) for protection against skin reactions induced by radiation therapy and management of these reactions. The products are cream emulsions, available without a prescription, that work by providing an optimum environment for the skin's healing process.

The application of Biafine WDE and Biafine RE result in the recruitment of macrophages to the wound site, which facilitate healing through all phases of the healing process. Macrophage recruitment assists in debridement, the removal of dead cells and tissue. Biafine's physical structure of oil in water also aids in the removal of dead tissues and its emollient action helps liquify these tissues. The emulsion provides a protective physical barrier against external contamination as well as a moist environment, and aids in the absorption of exudates, the fluids that result from a wound.

Adequate hydration is essential to the healing process. Because its water content is highly available to the wound site, Biafine WDE and Biafine RE provide deep dermal hydration: 41 percent of their water content is absorbed deep in the skin within the first hour of application.

Biafine, a leading wound, radiodermatitis and burn care product in Europe, has been used for more than two decades by physicians, fire departments, emergency room personnel and radiation therapy facilities.

Macrophage Impact on the Healing Process

Macrophages are cells which aid the healing process in several ways, including the removal of foreign particles and microorganisms. Macrophages occur in the walls of blood vessels and are usually immobile until stimulated by inflammation resulting from a wound or infection. The healing process consists of three phases: 1) inflammation, during which macrophages assist in autolytic debridement, the removal of dead cells and tissue debris from the wound site; 2) proliferation, in which macrophages stimulate the production and activity of fibroblasts, cells responsible for the production of materials essential to healing such as collagen; and 3) maturation, when fibroblast proliferation promotes multiplication and growth of skin cells through chemical messengers such as fibroblast growth factor and macrophage-derived growth factor. The unique formulation of Biafine recruits macrophages to the wound site during all three phases.

Biafine WDE for Dermal Wounds

Biafine WDE can be used for a variety of full- and partial-thickness dermal wounds, including dermal, vascular, arterial, diabetic, and pressure ulcers, as well as first and second degree burns. The product is a fluid, yet firm, emulsion that will conform to the contours of a wound and is available in 45-ml and 100-ml tubes. Biafine WDE can be used safely with topical antibiotics.

According to the most recent data available from the National Center for Health Statistics, in 1992, there were a total of 34 million emergency room visits that were injury-related, generating over 9.2 billion dollars in healthcare costs. Wound care was performed at approximately one-third of these visits.

In addition to wounds resulting from surgery or injury, Biafine WDE can be used for dermal ulcers, which are open sores on any external surface of the body. Diabetics often suffer from dermal ulcers, usually on their feet. Biafine WDE can also be used for pressure ulcers, known more commonly as bedsores. Pressure ulcers occur in 5 to 9% of all hospitalized patients and in 23 percent of all nursing home patients. Biafine WDE can also be used for chronic or delayed healing wounds. Application of Biafine WDE can renew the healing process in wounds that have not yet healed for years. In addition, Biafine WDE can be used for the management of first and second degree burns.

First degree burns are classified as those that involve only the epidermis (outermost layer of the skin) and are most commonly the result of overexposure to ultraviolet radiation, such as sunburn. Second degree burns are usually flash burns or the result of scalds. Because Biafine WDE is water-soluble, it can be gently washed away with saline without harming newly formed tissues. Its herbal-based fragrance helps to remove the odors associated with exudates, the fluids that result from wounds.

Biafine RE for Radiodermatitis

Radiation therapy is used to treat many kinds of cancer in almost any part of the body. One common side effect of radiation therapy is radiodermatitis, in which the skin in the treatment area begins to look reddened, irritated or burned. Radiation-treated skin may also develop a "moist reaction," especially where there are skin folds, and may become very sore. Patients given radiation therapy for breast cancer are especially at risk for radiodermatitis. Biafine RE is available in 45-ml and 20-ml tubes as a prophylaxis against radiodermatitis and for the management of the condition.

The application of Biafine RE as a prophylaxis to reduce the incidence and severity of radiation induced skin reactions may be initiated immediately following the first session. If a skin reaction occurs after radiation therapy, Biafine RE can be applied as a wound dressing to manage radiodermatitis. In more severe cases of radiodermatitis, it should be applied in thick layers and may be covered with a gauze dressing if necessary.

Biafine WDE and Biafine RE are products of Laboratoire Medix, headquartered in France, and are marketed in North America by Medix Pharmaceuticals Americas, Inc., a Washington, D.C.-based corporation.