Extended Release Minocycline Approved For Severe Acne

Medicis has announced that the U.S. Food and Drug Administration ("FDA") has approved its New Drug Application ("NDA") for SOLODYN(TM) (minocycline HCl, USP) Extended Release Tablets. SOLODYN(TM) is the only oral minocycline approved for once daily dosage in the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. SOLODYN(TM) is also the only approved minocycline in extended release tablet form. SOLODYN(TM) is lipid soluble, and its mode of action occurs in the skin and sebum. SOLODYN(TM) is not bioequivalent to any other minocycline products, and is in no way interchangeable with other forms of minocycline.

The dosing and administration for SOLODYN(TM) is unique, and redefines minocycline therapy for acne. Based on extensive multi-year clinical trials conducted by Medicis in which over 1,000 patients participated, the recommended dosage for SOLODYN(TM) is 1 mg/kg daily. In Medicis sponsored studies, higher doses of minocycline were tested against SOLODYN(TM), and did not show additional therapeutic benefits in the treatment of inflammatory lesions of acne. These higher doses, consistent with traditional minocycline use, may actually be associated with more acute vestibular side effects.