Amzeeq (minocycline)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved October 2019

Specific Treatments:

acne

Therapeutic Areas

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General Information

Amzeeq (minocycline) is a tetracycline-class drug. It is a broad-spectrum antibiotic.

Amzeeq is specifically indicated for the topical treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older.

Amzeeq is supplied as a foam for topical administration. After shaking the can well, a small amount of topical foam (e.g. a cherry-sized amount) should be expressed from the can onto the fingertips of the hand and then rubbed into acne-affected parts of the face. This should be repeated as needed until all acne-affected parts of the face are treated. If acne is present on other parts of the patient’s body (neck, shoulders, arms, back or chest), additional amounts of topical foam should also be applied to these areas.  The topical foam should be applied at approximately the same time each day at least 1 hour before bedtime. The patient should not bathe, shower or swim for at least 1 hour after application of the product.

Clinical Results

FDA Approval

The FDA approval of Amzeeq was based on data from three Phase 3 clinical trials in 2,418 patients of 9 years of age or older, making it one of the largest clinical programs for acne to date. In each 12-week, multicenter, randomized, double-blind, vehicle-controlled study, subjects with moderate to severe acne vulgaris were treated once-daily with Amzeeq or vehicle. No other topical or systemic acne medication was permitted to be used by subjects during the study period. The studies each found statistically significant disease improvement with Amzeeq versus vehicle for the co-primary endpoint of absolute reduction of inflammatory lesions, while studies 2 and 3 demonstrated a statistically significant improvement in IGA treatment success. IGA treatment success was defined as a score of 0 (“clear”) or 1 (“almost clear”) and at least a two-point decrease from baseline. Amzeeq was well-tolerated and no treatment-related serious adverse events were reported.

Side Effects

The most common adverse reaction associated with the use of Amzeeq was headache.

Mechanism of Action

Amzeeq (minocycline) is a tetracycline-class drug. The mechanism of action of Amzeeq for the treatment of acne is unknown.

Additional Information

For additional information regarding acne or Amzeeq, please visit the Amzeeq website.