Oral Rosacea Treatment Wins FDA Approval

CollaGenex said Tuesday it has received U.S. approval to market Oracea, which the company said is the first approved oral rosacea drug.
The company said the Food and Drug Administration has cleared for market Oracea to treat adults with the inflammatory lesions, including papules and pustules, caused by the skin condition.
CollaGenex said it would roll out the new dermatologic drug in July.
"Oracea is the first FDA-approved, orally-administered, systemically-delivered drug to treat rosacea," the company said in a statement.
Rosacea affects about 14 million adults in the United States, CollaGenex said.
"Oracea is the first of a series of dermatology products we have in development, and we are very pleased that our NDA was approved by the FDA within 10 months of submission," said Colin Stewart, CollaGenex's president and chief executive officer.

The Ingredients in Rosacea-Ltd

An overwhelming number of rosacea sufferers have found relief with Rosacea-Ltd. You need only to visit the online support groups to see the treatment mentioned often. But what is it?
The key to Rosacea Ltd is the direct delivery to the skin of many well known and well documented anti-rosacea, anti-acne, and anti-seborrheic dermatitis ingredients without the usual accompanying side effects. Rosacea treatments should treat rosacea symptoms without side effects.

These ingredients in Rosacea-Ltd are as follows:

A. Zinc has been used for decades by througout the medical profession for the treatment of the symptoms of inflammatory acne. Zinc is administered either as the primary ingredient or in conjunction with other anti-acne medications. Zinc can be found in different forms in many over-the-counter skin care products and anti-acne medications. Topically applied zinc has been shown to have a potent anti-septic effect. More specifically, evidence suggests that zinc has anti-bacterial and anti-fungal actions, as well as mild anti-inflammatory actions.

B. Sulfur is extremely effective in the treatment of rosacea-related papules and pustules. Many dermatologists tailor rosacea treatments for rosacea symptom to the individual by varying the concentration of sulfur in a given preparation (from 2 percent to 15 percent sulfur). These higher percentages may cause some skin irritation in some of the more sensitive rosacea patients, for this reason Rosacea-Ltd has devised a patented formula delivering a smoother, more compatible dose in a non-prescription product.  

C. Sodium Chloride and Copper Oxide: These ingredients have long been well known for their anti-bacterial, anti-inflammatory actions.

Treatment of Rosacea Places Emphasis on Topical Therapies

Due to the development and release of newer topical rosacea formulations, the diagnosis and treatment of rosacea has received renewed attention over the past 3-5 years both in the literature and at medical symposia. Rosacea is a very common facial dermatosis. In the US, rosacea is estimated to affect 14 million people, predominantly adults with approximately 60% of cases diagnosed before the age of 50. A frustrating aspect of rosacea is it's inherent chronicity punctuated with periods of exacerbation and relative remission. A variety of rosacea subtypes have been identified which correlate with the patients rosacea clinical presentation. Although the pathogenesis of rosacea is poorly understood, multiple topical rosacea agents are available. The efficacy of topical therapy for rosacea relates primarily to reduction in inflammatory lesions (papules, pustules), decreased intensity of rosacea erythema, a reduction in the number and intensity of flares and amelioration of rosacea symptoms, which may include stinging, pruritus and burning. The list of main topical rosacea treatments utilised for the treatment of rosacea include metronidazole, sulfacetamide-sulfur, azelaic acid and topical antibiotics (clindamycin, erythromycin). Depending on the severity at initial presentation, topical therapy may be combined with systemic antibiotic rosacea therapy (e.g., oral tetracycline derivative). Newer choices primarily involve improved vehicle formulations, which demonstrate favourable skin tolerability and cosmetic elegance.

PMID: 14680431 [PubMed - indexed for MEDLINE]