Ximino

CLINICAL PHARMACOLOGY

Mechanism of Action

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

Pharmacodynamics

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

Pharmacokinetics

Ximino is not bioequivalent to immediate release minocycline products.

Following administration of a single dose of Ximino (135 mg) to healthy male and female adult subjects, the mean (SD) AUC(0-∞) and Cmax were 12.87 (4.04) mcg x hr/mL and 0.68 (0.25) mcg/mL, respectively, under fasting conditions.

When a single dose of Ximino (135 mg) was administered with a high fat meal to the same subjects in the same study in a crossover design, the mean (SD) AUC(0-∞) and Cmaxwere 14.16 (3.10) mcg x hr/mL and 0.85 (0.20) mcg/mL, respectively.

A single-dose, crossover study demonstrated that Ximino (45 mg and 135 mg) exhibited dose-proportional pharmacokinetics.

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

Clinical Studies

The safety and efficacy of 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 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 (Ibs) Subject's Weight (kg) Available Capsule Strength (mg) Actual mg/kg Dose
99 to 131 45 to 59 45 1 to 0.76
132 to 199 60 to 90 90 1.5 to 1
200 to 300 91 to 136 135 1.48 to 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

  Study 1 Study 2
Minocycline hydrochloride
(1 mg/kg)
N = 300
Placebo
N = 151
Minocycline
hydrochloride
(1 mg/kg)
N = 315
Placebo
N = 158
Mean Percent Improvement in Inflammatory Lesions 43.1% 31.7% 45.8% 30.8%
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

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

Last reviewed on RxList: 7/30/2012
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.

Health Resources
advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations