Solodyn

CLINICAL PHARMACOLOGY

Mechanism of Action

The mechanism of action of SOLODYN for the treatment of acne is unknown.

Pharmacodynamics

The pharmacodynamics of SOLODYN for the treatment of acne are unknown.

Pharmacokinetics

SOLODYN Tablets are not bioequivalent to non-modified release minocycline products. Based on pharmacokinetic studies in healthy adults, SOLODYN Tablets produce a delayed Tmax at 3.5-4.0 hours as compared to a non-modified release reference minocycline product (Tmax at 2.25-3 hours). At steady-state (Day 6), the mean AUC(0–24) and Cmax were 33.32 μghr/mL and 2.63 μg/mL for SOLODYN Tablets and 46.35 μghr/mL and 2.92 μg/mL for Minocin® capsules, respectively. These parameters are based on dose adjusted to 135 mg per day for both products.

A single-dose, four-way crossover study demonstrated that SOLODYN Tablets used in the study (45 mg, 90 mg, 135 mg) exhibited dose-proportional pharmacokinetics. In another single-dose, five-way crossover pharmacokinetic study, SOLODYN Tablets 55 mg, 80 mg, and 105 mg were shown to be dose-proportional to SOLODYN Tablets 90 mg and 135 mg.

When SOLODYN Tablets were administered concomitantly with a meal that included dairy products, the extent and timing of absorption of minocycline did not differ from that of administration under fasting conditions.

Minocycline is lipid soluble and distributes into the skin and sebum.

Clinical Studies

The safety and efficacy of SOLODYN in the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris was assessed in two 12-week, multi-center, randomized, double-blind, placebo-controlled, trials in subjects ≥ 12 years. The mean age of subjects was 20 years and subjects were from the following racial groups: White (73%), Hispanic (13%), Black (11%), Asian/Pacific Islander (2%), and Other (2%).

In two efficacy and safety trials, a total of 924 subjects with non-nodular moderate to severe acne vulgaris received SOLODYN or placebo for a total of 12 weeks, according to the following dose assignments.

Table 3: Clinical Studies Dosing Table

Subject’s Weight (lbs.) Subject’s Weight (kg) Available Tablet Strength (mg) Actual mg/kg Dose
99 – 131 45 – 59 45 1 – 0.76
132 – 199 60 – 90 90 1.5 – 1
200 – 300 91 – 136 135 1.48 – 0.99

The two primary efficacy endpoints were:

  1. Mean percent change in inflammatory lesion counts from Baseline to 12 weeks.
  2. Percentage of subjects with an Evaluator's Global Severity Assessment (EGSA) of clear or almost clear at 12 weeks. Efficacy results are presented in Table 4.

Table 4: Efficacy Results at Week 12

  Trial 1 Trial 2
SOLODYN (1 mg/kg)
N = 300
Placebo
N = 151
SOLODYN (1 mg/kg)
N = 315
Placebo
N = 158
Mean Percent Improvement in Inflammatory Lesions 43.10% 31.70% 45.80% 30.80%
No. (%) of Subjects Clear or Almost Clear on the EGSA* 52 (17.3%) 12 (7.9%) 50 (15.9%) 15 (9.5%)
*Evaluator's Global Severity Assessment

SOLODYN did not demonstrate any effect on non-inflammatory lesions (benefit or worsening).

Last reviewed on RxList: 10/31/2013
This monograph has been modified to include the generic and brand name in many instances.

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