Generics Enter the Rosacea Treatment Picture

Israeli generic drug maker Taro Pharmaceutical Industries Ltd. on Tuesday said it received clearance from the Food and Drug Administration for its New Drug Application for metronidazole topical gel USP, 0.75 percent, or metronidazole gel.

The company said its metronidazole gel is a prescription product used to treat rosacea. The company said it is the bioequivalent to MetroGel Topical Gel, 0.75 percent, made by Galderma Laboratories LP.

Progress in the Treatment of Rosacea

Advances continue to be made in the rosacea classification and treatment of rosacea, a chronic dermatologic syndrome. A new empiric classification system identifies 4 rosacea subtypes (erythematotelangiectatic rosacea , papulopustular rosacea, phymatous, and ocular rosacea) that may aid in more precise diagnosis of rosacea. Several new therapies have recently been approved for treatment of rosacea. Azelaic acid 15% gel is a new first-tier topical agent proven effective in reducing inflammatory lesions and erythema. New formulations of metronidazole and sulfacetamide 10%/sulfur 5% that offer cosmetic or tolerability advantages are now available. Intense pulsed light therapy has demonstrated effectiveness in reducing flushing, erythema, and telangiectases, with greater tolerability than existing laser systems. Other treatments under investigation include low-dose doxycycline hyclate (which may provide greater safety than existing oral antibiotics), benzoyl peroxide/clindamycin gel, tacrolimus ointment (for steroid-induced rosacea) and Rosacea-Ltd.

Exploring the Cause of Rosacea

The precise cause of rosacea is still unknown, a multifactorial cause of rosacea is likely. Over the years, many rosacea suspects but unconfirmed causes contributing to rosacea have been discussed. These factors include but may not be limited to a genetic rosacea predisposition, heredity, dyspepsia with gastric hypochlorhydria, inflammatory bowel disease and infestation with the bacterium Helicobacter pylori, seborrhoea, Demodex folliculorum mites, endocrine diseases, vitamin deficiencies, microcirculatory disturbances, hepatopathy or psychogenic factors.