Dermatology Express Report™ Fax

Publication date: 2006-07-14

Weight-based Dosing of a Novel Antibiotic for Moderate-to-Severe Acne Vulgaris—Redefining Minocycline

This report was reviewed for medical and scientific accuracy by Medical Review by Amy S. Paller, MD, Professor and Chair of Dermatology, Professor of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.

Expert Commentary

Alan R. Shalita, MD, Professor and Chairman, Department of Dermatology, Downstate Medical Center, State University of New York (SUNY), Brooklyn, New York

The recent approval of minocycline extended-release tablets (Solodyn) by the Food and Drug Administration (FDA) offers a significant advancement for treating moderate-to-severe acne vulgaris. Minocycline extended-release tablets were formulated to provide optimal efficacy in treating moderate-to-severe acne vulgaris while potentially minimizing the vestibular adverse effects that have been associated with minocycline administration.¹ Unlike available immediate-release minocycline formulations, mino-cycline extended-release tablets offer a unique pharmacokinetic delivery that, when dosed on a 1 mg/kg weight-basis,² provides the lowest effective dose of minocycline for treating moderate-to-severe acne vulgaris while minimizing potential adverse events. In addition, minocycline extended-release tablets are administered once daily, thus offering the potential to enhance patient compliance. Minocycline extended-release tablets are indicated for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris and represent the first oral systemic antibiotic approved by the FDA as first-line therapy for the treatment of acne.²

Acne affects between 40 and 50 million individuals in the United States.³ Although acne is typically associated with adolescence, affecting 79% to 95% of 16- to 18-year-old adolescents,^4–6 acne may also affect children and adults. In 10- to 12-year-old children, acne affects from 28% to 61% of individuals.^4–6 In adults older than 25 years, 54% of women and 40% of men exhibit some degree of facial acne, with symptoms persisting into middle age.⁷

As the severity of acne may range from mild to severe, many topical and systemic therapies have been approved by the FDA for treating acne including benzoyl peroxide, topical retinoids (tretinoin, adapalene, tazarotene), topical antibiotic agents (erythromycin, clindamycin), systemic antibiotic agents (tetracycline, doxycycline, minocycline as adjunctive therapy), systemic retinoids (isotretinoin), and hormonal therapy (oral contraceptives). Systemic antibiotic therapy is typically reserved for the treatment of moderate-to-severe inflammatory acne, or acne considered emotionally burdensome for the patient for psychological or social reasons.⁸

For decades, physicians have used erythromycin, tetracycline, doxycycline, and minocycline to treat acne vulgaris. Compared with doxycycline and tetracycline, minocycline has been associated with the greatest log reduction of Propionibacterium acnes (P. acnes), most rapid onset of effect, and greatest residual reduction in P. acnes.⁹ Moreover, minocycline exhibits the lowest prevalence of P. acnes resistance compared with doxycycline, erythromycin, and tetracycline.¹⁰ Increasing resistance of P. acnes to oral antibiotics (eg, erythromycin, tetracycline) has been correlated with acne treatment failure.^11–13 Doxycycline may be limited by dose-related phototoxicity in some patients,¹⁴ and minocycline may be associated with vestibular adverse events (eg, vertigo, dizziness, headache) and tissue pigmentation.¹⁵

This Dermatology Express Report^TM Fax reviews the efficacy data of the newly approved minocycline extended-release tablets. A follow-up Dermatology Express Report^TM Fax which will be distributed in the near future, will review the safety and tolerability profiles of minocycline extended-release tablets.

Weight-based Dosing of Minocycline