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The Food and Drug Administration (FDA) has approved Minolira (minocycline HCl) extended-release tablets for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients aged ≥12 years.
This extended-release formulation of minocycline HCl, a tetracycline antibiotic, has not been evaluated for the treatment of infections. Its exact mechanism of action for the treatment of acne is not known.
Minolira was evaluated in two 12-week, multi-center, randomized, double-blind, placebo-controlled trials in patients aged ≥12 years. Across both trials, a total of 924 patients with non-nodular moderate to severe acne vulgaris were administered Minolira 1mg/kg or placebo for 12 weeks. The primary efficacy endpoints were mean percent change in inflammatory lesion counts from baseline to Week 12 and the percentage of patients with an Evaluator’s Global Severity Assessment (EGSA) of “clear” or “almost clear” at Week 12.
In Trial 1, patients in the Minolira group had a 43.1% mean improvement in inflammatory lesions vs. 31.7% of patients in the placebo group. There were 52 patients in the Minolira group (17.3%) who achieved clear or almost clear on EGSA vs. 12 patients in the placebo group (7.9%).
In Trial 2, patients in the Minolira group had a 45.8% mean improvement in inflammatory lesions vs. 30.8% of patients in the placebo group. There were 50 patients in the Minolira group (15.9%) who achieved clear or almost clear on EGSA vs. 15 patients in the placebo group (9.5%).
Minolira will be available as 105mg and 135mg strength scored tablets in 30-count bottles.
For more information call (888) 966-8766 or visit PromiusPharma.com.
