Medicis Announces FDA Approval of Solodyn
SCOTTSDALE, Ariz., May 8, 2006 -- Medicis today announced that the U.S. Food and Drug Administration ("FDA") has approved its New Drug Application ("NDA") for Solodyn (minocycline HCl, USP) Extended Release Tablets. Solodyn 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 is also the only approved minocycline in extended release tablet form. Solodyn is lipid soluble, and its mode of action occurs in the skin and sebum.
Solodyn 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 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 is 1 mg/kg daily. In Medicis sponsored studies, higher doses of minocycline were tested against Solodyn, 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. (See Note 1)
There were more than 7.5 million acne patient visits to physicians in 2005. Greater than 5 millionprescriptions were written by dermatologists for minocycline, doxycycline and/or tetracycline, totaling approximately $435 million in branded and generic retail dollars. Less than 20 percent of the 5 million prescriptions were written for branded products. (See Note 2)
Solodyn is patented until 2018 by U.S. Patent No. 5,908,838, which covers Solodyn's unique dissolution rate. Other patents covering Solodyn's dosing, pharmacokinetics, and carrier composition are pending. The Company continues to seek additional patent protection for its products.
"We are excited to announce FDA approval of Solodyn," said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. "Having the only oral patented minocycline extended release tablet for acne with once daily dosage is indicative of the innovation of our product pipeline. We believe Solodyn's unique, weight-based dosing will transform the way doctors prescribe minocycline, and improve the overall safety of oral antibiotic use in acne. With this highly specialized dosing method and safety profile, we believe Solodyn will be a leader in the oral antibiotic market for acne, where U.S. dermatologists prescribe minocycline more frequently than any other molecule." (See Note 3)Solodyn is available by prescription in the following extended release tablet dosages: 45 mg (NDC No. 99207-460-10 and NDC No. 99207-460-11) 90 mg (NDC No. 99207-461-10 and NDC No. 99207-461-11) 135 mg (NDC No. 99207-462-10 and NDC No. 99207-462-11).
When used as directed, Solodyn is safe and effective for the treatment of only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. The most commonly reported side effects associated with the use of Solodyn were headache, fatigue, dizziness, and pruritus. Central nervous system side effects including light-headedness, dizziness, or vertigo, have been reported with minocycline therapy, but were not significant in Solodyn clinical investigations. In rare cases, photosensitivity has been reported. Should not be used during pregnancy nor by individuals of either gender who are attempting to conceive a child while on therapy; concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective.
Solodyn is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. Safety beyond 12 weeks of use has not been established.
For more information about Solodyn, please visit www.solodyn.com.
The Company expects product supply to be available for shipping to wholesalers within the quarter, and anticipates promotion and sample distribution of Solodyn to physicians shortly thereafter. Solodyn currently is manufactured by AAIPharma Inc. in Wilmington, NC.References: Note 1: MP-0104-01, "A Randomized, Double-Blind, Placebo-Controlled Phase II Dose Ranging Study of an Oral Extended Release Formulation of Minocycline as Primary Therapy for Acne Vulgaris in Participants 12-30 Years of Age." Note 2: IMS Health, 2005 Note 3: IMS Health, 2005
Posted: May 2006