CollaGenex Pharmaceuticals received approval from the Food & Drug Administration in late May to market Oracea. According to the company, this is the first systemically delivered treatment for the treatment of rosacea. Affecting an estimated 14 million adults in the United States, rosacea is a dermatological condition characterized by papules and pustules, erythema, and telangiectasia.
"Oracea is a low-dose doxycycline used at subantimicrobial levels to capitalize on its anti-inflammatory and antiangiogenic properties," Allison Vidimos, R.Ph., M.D., told Drug Topics. Vidimos, who is chairman of the department of dermatology at the Cleveland Clinic, went on to say that at low levels, tetracyclines reduce inflammatory lesions without increasing resistant flora of the skin.
According to the manufacturer, Oracea 40-mg capsules are a unique formulation of doxycycline that contains 30 mg of immediate-release and 10 mg of delayed-release beads. The efficacy and safety of the new formulation were proven in two phase III trials involving 537 patients. The results showed a 61% and 46% mean reduction in inflammatory lesions compared with 29% and 20% reduction, respectively, in patients taking placebo (p<0.001 for each study).
Plasma levels of doxycycline achieved with Oracea therapy are lower than those achieved with other doxycycline products, and therefore the drug should not be used for treating bacterial infections or antibacterial prophylaxis, according to CollaGenex.
"Patient instructions should include avoidance during breastfeeding or pregnancy and in those patients allergic to other tetracy-clines," noted Vidimos. Medications that could impair the effect of doxycycline include antacids and supplements containing aluminum, calcium, and magnesium. "The dosage of anticoagulants may need to also be adjusted, and oral contraceptives may be less effective when taken with doxycycline," she said.
In addition, Oracea can affect tooth development and, if used in children under eight years of age, may cause permanent tooth damage and discoloration of the teeth to a yellow-gray-brown color. Doxycycline has also been shown to sensitize the skin, leading to an exaggerated sunburn reaction. Patients should be advised to minimize or avoid exposure to sunlight and wear clothing that protects the skin from the sun. The most common adverse reactions observed during clinical trials included nasopharyngitis, sinusitis, fungal infection, influenza, diarrhea, and hypertension.
The use of Oracea may result in overgrowth of nonsusceptible microorganisms, such as fungi, states the prescribing information. Oracea should be used with caution in patients who are predisposed to or have a history of candidiasis. Bacterial resistance to tetracyclines may also develop with doxycycline.
According to CollaGenex, Oracea capsules have been manufactured for launch and the company will begin distribution in July.
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