Monday, dermatological products maker Medicis Pharmaceutical Corp. (MRX) said that the U.S. Food and Drug Administration has approved additional strengths of Solodyn Extended Release Tablets for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients aged 12 years and above.
The approval spans dosages of 55 mg, 80 mg and 105 mg, and are covered by patent rights, including two patent applications for which the U.S. Patent and Trademark Office recently issued Notice of Allowance, the company said.
Medicis Chief Executive Officer Jonah Shacknai said, "These three new strengths will complement the current Solodyn lineup to offer physicians greater weight-based dosing precision of Solodyn, and make Solodyn the first and only extended release minocycline with eight FDA-approved dosing strengths..."
According to the American Academy of Dermatology, acne is the most common skin disorder in the U.S., affecting 40 million to 50 million Americans. According to IMS Health, more than 5.6 million prescriptions were written by dermatologists for minocycline, doxycycline and/or tetracycline, totaling over $1.2 billion in branded and generic retail dollars.
Medicis expects product supply to be available for shipping to wholesalers within the quarter. Solodyn currently is manufactured by Canada-based WellSpring Pharmaceutical Canada Corp., and North Carolina-based AAIPharma Inc.
While announcing its second quarter results on August 5, the company reported a 23.2% rise in revenues, driven by strong sales from its acne treating portfolio comprising Solodyn, Ziana and Triaz.
Solodyn was launched in 2006, and is the only branded oral minocycline approved for once daily dosage in the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris, the company noted.
The dosing and administration for Solodyn is based on extensive, multi-year clinical trials covering over 1,000 patients. The study revealed that higher doses of Solodyn, that is 2 and 3 mg/kg/day, tested against 1 mg/kg/day Solodyn did not show additional therapeutic benefits in the treatment of inflammatory lesions of acne. Also, higher doses have not been shown to be of additional benefit, and may be associated with more acute vestibular side effects, the company noted.
Further, Medicis said that Solodyn, when used as directed is well tolerated and effective, with the most commonly reported side effects being headache, fatigue, dizziness and pruritus.
MRX closed Friday's regular trade at $26.93 on the NYSE.
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