Solodyn
CLINICAL PHARMACOLOGY
Mechanism of Action
The mechanism of action of SOLODYN® (minocycline hydrochloride) for the treatment of acne is unknown.
Pharmacodynamics
The pharmacodynamics of SOLODYN® (minocycline hydrochloride) for the treatment of acne are unknown.
Pharmacokinetics
SOLODYN® (minocycline hydrochloride) Tablets are not bioequivalent to non-modified release minocycline products. Based on pharmacokinetic studies in healthy adults, SOLODYN® (minocycline hydrochloride) 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 µg×hr/mL and 2.63 µg/mL for SOLODYN® (minocycline hydrochloride) Tablets and 46.35 µg×hr/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 all strengths of SOLODYN® (minocycline hydrochloride) Tablets used in the study (45 mg, 90 mg, 135 mg) exhibited dose-proportional pharmacokinetics.
When SOLODYN® (minocycline hydrochloride) 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® (minocycline hydrochloride) 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, studies 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® (minocycline hydrochloride) 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 Caplet 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:
- Mean percent change in inflammatory lesion counts from Baseline to 12 weeks.
- 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
| Study 1 | Study 2 | |||
| SOLODYN® (minocycline hydrochloride) (1 mg/kg) N = 300 |
Placebo N = 151 |
SOLODYN® (minocycline hydrochloride) (1 mg/kg) N = 315 |
Placebo N = 158 |
|
| Mean Percent Improvement in | 43.1% | 31.7% | 45.8% | 30.8% |
| Inflammatory Lesions 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® (minocycline hydrochloride) did not demonstrate any effect on non-inflammatory lesions (benefit or worsening).
Last reviewed on RxList: 1/27/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional Solodyn Information
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