If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Regranex Gel For Diabetic Foot Ulcers Now Available In U.S. RARITAN, NJ -- April 16, 1998 -- More than two million people with diabetes will develop diabetic foot ulcers, one of the most difficult wounds to heal, during their lifetime. Now, a new prescription drug is available that may help many of these patients. Ortho-McNeil Pharmaceutical, Inc.’s Regranex(R) (becaplermin) Gel 0.01%, the first topical biologic proven to increase the incidence of complete healing in diabetic neuropathic foot ulcers, is now available by prescription in the United States through local pharmacies. The U.S. Food and Drug Administration approved Regranex Gel December 1997. The product is indicated for diabetic neuropathic foot ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. Regranex Gel is an adjunct to -- and not a substitute for -- good wound care, which includes initial sharp debridement, pressure relief and infection control. Foot ulcers often go undetected since other ailments associated with diabetes, such as nerve damage and visual and circulatory problems, make it difficult for patients to feel or see the ulcer as it develops. These wounds can lead to serious complications, including severe infections and amputation. "Diabetic foot ulcers are a serious problem in this country, resulting in 67,000 amputations each year," said Mayer Davidson, M.D., president of the American Diabetes Association. "Diabetic foot disease costs the nation more than $1 billion [US] each year." "Wound healing is a complex process that, until now, only Mother Nature could influence," said David Steed, M.D., professor of surgery, University of Pittsburgh, and a Regranex Gel clinical trial investigator. "Now, with Regranex Gel, we have something that no drug has ever offered before, a simple, easy-to-use treatment that actually stimulates the body to heal more diabetic ulcers." Diabetic neuropathic foot ulcers are one of the most difficult types of wounds to heal. Regranex Gel is the first prescription biologic that actively stimulates the body to grow new tissue to heal these wounds. The active ingredient in Regranex Gel is becaplermin, a genetically-engineered platelet-derived growth factor that mimics a protein that occurs naturally in the body. The growth factor stimulates the migration of cells to the ulcer site, encouraging the patient's body to grow new tissue that heals these open wounds. Becaplermin is produced by recombinant technology in yeast cells and is not derived from blood. Clinical trials demonstrated that a once daily topical application of Regranex Gel plus good wound care healed more diabetic neuropathic ulcers than a placebo gel plus good wound care. Regranex Gel was well tolerated in all clinical trials. Incidence of adverse events was similar in patients treated with Regranex Gel, placebo gel or good wound care alone. The product has not been studied in the treatment of diabetic neuropathic ulcers that do not extend into the subcutaneous tissue or beyond (Stage I or Stage II, IAET staging classification). The efficacy of Regranex Gel for the treatment of non-diabetic ulcers is under evaluation. Regranex Gel is contraindicated in patients with known neoplasms at the site of application. The product is contraindicated in patients with known hypersensitivity to any component of this product. Erythematous rashes occurred in two percent of patients treated with Regranex Gel. The product should not be used in wounds that close by primary intention. More information on: Ortho-McNeil Pharmaceutical Inc..
|
