Noritate

CLINICAL PHARMACOLOGY

Pharmacokinetics: When one gram dose of NORITATE (metronidazole) cream, 1%, was applied in a single application to the face of 16 healthy volunteers, low concentrations of metronidazole were detected in the plasma of 7 of the volunteers. The mean ± SD Cmax of metronidazole was 27.6 ± 7.3 ng/mL, which is about 1% of the value reported for a single 250 mg oral dose of metronidazole. The time to maximum plasma concentration (Tmax) in the volunteers with detectable metronidazole was 8-12 hours after topical application.

Pharmacodynamics: The mechanisms by which metronidazole acts in reducing inflammatory lesions of rosacea are unknown. Clinical Studies: Safety and efficacy of NORITATE (metronidazole) were evaluated in two randomized vehicle-controlled clinical studies for the treatment of rosacea, which excluded patients who had nodules, moderate or severe rhinophyma, dense telangiectases, plaque-like facial edema or ocular involvement and those who had a history of not responding to metronidazole therapy for rosacea. Of the patients included in the efficacy database (n=416), there were 142 men and 274 women. Endpoint efficacy data comparisons for patients treated with daily NORITATE (metronidazole) or vehicle applications are listed below.

Inflammatory Lesion Counts and Erythema Severity Scores in Two Clinical Trials for Rosacea

 

Noritate

Vehicle

 

Study 1

Study 2

Study 1

Study 2

 

N

Result

N

Result

N

Result

N

Result

                 

Papules + Pustules

               

Count

               

Baseline

89

15

92

19

50

18

49

17

Week-10

80

7*

82

8

45

15

41

12

Reduction

 

49%*

 

58%*

 

17%

 

30%

Papules

               

Count

               

Baseline

89

13

92

17

50

15

49

15

Week-10

80

7*

82

7

45

12

41

11

Reduction

 

41%*

 

55%*

 

14%

 

28%

Erythema Score

               

Baseline

89

2.2

92

2.3

50

2.2

49

2.2

Week-10

80

1.3*

82

1.4*

45

1.7

40

1.8

Reduction

 

42%

 

40%

 

25%

 

19%

*Statistically significant differences between NORITATE (metronidazole) and vehicle groups with p≤0.05. Erythema scores: 0=none, 1=mild, 2=moderate and 3=severe.

Safety Studies: Studies of contact sensitization (n=258), phototoxicity (n=21), and photocontact sensitization (n=29) of NORITATE (metronidazole) were conducted. No evidence of sensitization or phototoxicity was seen in these studies.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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