Trial Design: In a phase 2 dose-ranging study of 233 subjects with the 45 mg, 90 mg, and 135 mg dosage strengths, patients receiving extended-release SOLODYN Tablets ~1 mg/kg/day experienced a statistically significant (P=0.015) reduction in inflammatory lesions (56.8%) compared with patients receiving placebo (39.4%). Patients entering the phase 2 study had 39 to 47 inflammatory facial lesions; those entering the phase 3 studies were enrolled with 25 to 752,3
SOLODYN is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.
SOLODYN did not demonstrate any effect on non-inflammatory acne lesions. Safety of SOLODYN has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SOLODYN should be used only as indicated.
To report SUSPECTED ADVERSE REACTIONS contact Ortho Dermatologics at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
*This offer is only valid for patients with commercial insurance. Eligible uninsured patients will pay more. This offer is not valid for any person eligible for reimbursement of prescriptions, in whole or in part, by any federal, state, or other governmental programs, including, but not limited to, Medicare (including Medicare Advantage and Part A, B, and D plans), Medicaid, TRICARE, Veterans Administration or Department of Defense health coverage, CHAMPUS, the Puerto Rico Government Health Insurance Plan, or any other federal or state health care programs. This offer is good only in the U.S. at retail pharmacies owned and operated by Walgreen Co. (or its affiliates) or other participating independent retail pharmacies. This offer is not valid in Massachusetts or Minnesota or where otherwise prohibited, taxed or otherwise restricted. Click here for other terms and conditions that apply.
References: 1. SOLODYN Tablets Package Insert. Valeant Pharmaceuticals North America LLC. 2. Data on file, Valeant Pharmaceutical Corporation. 3. Stewart DM, Torok HM, Weiss JS, Plott RT; for the Solodyn Phase 2 Study Group. Dose-ranging efficacy of new once-daily extended-release minocycline for acne vulgaris. Cutis. 2006;78(4 suppl):11-20.