FDA News

FDA approves minocycline topical foam for acne

The FDA has approved Amzeeq topical foam 4% for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.

Stein Gold Linda
Linda Stein Gold

"Amzeeq topical minocycline foam 4% offers a novel treatment of acne which is effective and well tolerated," Linda Stein Gold, MD, director of dermatology clinical research at Henry Ford Health System, told Healio Dermatology. "This drug delivers high concentrations of minocycline into the skin with minimal systemic absorption. This may allow for decreased use of systemic antibiotics."

This is the first topical minocycline approved by the FDA for any condition, according to a press release from Foamix Pharmaceuticals.

Minocycline is a broad-spectrum antibiotic known for its efficacy in treating acne, but it can cause systemic side effects when taken orally, according to the release.

The approval is supported by three phase 3 clinical trials that enrolled 2,418 patients aged 9 years and older. In the 12-week randomized, double-blind, vehicle-controlled studies, participants were treated with Amzeeq or vehicle once daily. The studies found statistically significant disease improvement with Amzeeq vs. vehicle in absolute reduction of inflammatory lesions. In addition, in two studies, a statistically significant improvement in Investigator’s Global Assessment treatment success was found, according to the release.

Headache was the most common adverse reaction found in the studies, reported in 3% of participants taking Amzeeq vs. 2% of those treated with vehicle.

The company expects the treatment to be available for prescribing in January 2020.

Disclosure: Stein Gold reports being an investigator and advisor for Foamix.

The FDA has approved Amzeeq topical foam 4% for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.

Stein Gold Linda
Linda Stein Gold

"Amzeeq topical minocycline foam 4% offers a novel treatment of acne which is effective and well tolerated," Linda Stein Gold, MD, director of dermatology clinical research at Henry Ford Health System, told Healio Dermatology. "This drug delivers high concentrations of minocycline into the skin with minimal systemic absorption. This may allow for decreased use of systemic antibiotics."

This is the first topical minocycline approved by the FDA for any condition, according to a press release from Foamix Pharmaceuticals.

Minocycline is a broad-spectrum antibiotic known for its efficacy in treating acne, but it can cause systemic side effects when taken orally, according to the release.

The approval is supported by three phase 3 clinical trials that enrolled 2,418 patients aged 9 years and older. In the 12-week randomized, double-blind, vehicle-controlled studies, participants were treated with Amzeeq or vehicle once daily. The studies found statistically significant disease improvement with Amzeeq vs. vehicle in absolute reduction of inflammatory lesions. In addition, in two studies, a statistically significant improvement in Investigator’s Global Assessment treatment success was found, according to the release.

Headache was the most common adverse reaction found in the studies, reported in 3% of participants taking Amzeeq vs. 2% of those treated with vehicle.

The company expects the treatment to be available for prescribing in January 2020.

Disclosure: Stein Gold reports being an investigator and advisor for Foamix.