Allergan Announces FDA Approval of ACZONE (dapsone) Gel, 7.5% for Treatment of Acne Vulgaris

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The FINANCIAL — Allergan plc on February 25 announced that the Company has received approval from the U.S. Food and Drug Administration (FDA) to market ACZONE (dapsone) Gel, 7.5%, a new prescription topical treatment for acne in patients 12 years of age and older. ACZONE Gel, 7.5% delivers proven efficacy to treat both inflammatory and non-inflammatory acne, with a new concentration of dapsone in just once-a-day application.

“For the ACZONE Gel, 7.5% pivotal trials, we studied 4,340 acne patients, demonstrating efficacy and tolerability. The new FDA product approval also offers just once-daily dosing and a new pump delivery system,” said David Nicholson, Executive Vice President and President of Global R&D Brands at Allergan. “As part of Allergan’s commitment to the medical dermatology space, we have truly raised the bar for ourselves in efforts to offer an effective acne product to address physician and patient needs.”

In clinical trials of ACZONE Gel, 7.5%, safety and efficacy were assessed in two identically designed, randomized, multi-centered, double-blind, vehicle-controlled 12-week studies. A total of 4,340 acne patients were randomized to receive either ACZONE Gel, 7.5% (n=2162) or vehicle (n=2178). The majority of patients (99%; n=4339) had moderate acne, with a baseline score of 3 on the Global Acne Assessment Score (GAAS). ACZONE Gel, 7.5% was approved based on co-primary endpoints of the GAAS and lesion counts (20 to 50 inflammatory and 30 to 100 non-inflammatory lesions at baseline). At week 12, inflammatory lesions were reduced by 15.8 lesions (54.6%; n=2162) vs 13.9 lesions with vehicle (48.1%; n=2178), and non-inflammatory lesions were reduced by 20.7 lesions (45.1%) vs 18.0 lesions with vehicle (39.4%).2 The GAAS success rate in patients was 29.8% (n=2162) vs 21.1% with vehicle (n=2178), according to Allergan.

In addition to efficacy, ACZONE Gel, 7.5% has a proven tolerability profile. Out of 2161 patients who used ACZONE Gel, 7.5%, 1.1% experienced mild application-site dryness vs 1.0% with vehicle (n=2175), and 0.9% experienced pruritus vs 0.5% with vehicle. 

“ACZONE Gel, 7.5%, is a new once-daily option that was shown to have significant improvement in patients’ acne after 12 weeks of use,” said Linda Stein Gold, MD, Director of Dermatology Clinical Research, Division Head of Dermatology at Henry Ford Health System in Michigan and a lead investigator in the studies. “This new formulation was well-tolerated, which is especially important to many of my female patients.”

ACZONE Gel, 7.5% will be available in May 2016 nationwide.

Approved Use

ACZONE (dapsone) Gel, 7.5% is a prescription medicine used on the skin (topical) to treat acne in people 12 years and older.

Important Safety Information

Tell your doctor about all of your medical conditions, including if you have; glucose-6-phosphate dehydrogenase deficiency (G6PD) or higher than normal levels of methemoglobin in your blood (methemoglobinemia).

Talk to your doctor about any medications you’re using including topical benzoyl peroxide (BPO). Use of BPO with ACZONE® Gel may cause your skin and facial hair to temporarily turn yellow or orange at the site of application.

ACZONE Gel, 7.5% may cause serious side effects, including:

a decrease of oxygen in your blood caused by a certain type of abnormal red blood cell (methemoglobinemia).  If your lips, nail beds or the inside of your mouth turns grey or blue, stop using ACZONE Gel, 7.5% and get medical help right away.

a breakdown of red blood cells (hemolytic anemia) for some people with G6PD deficiency using ACZONE Gel, 7.5%.  If you get any of the following signs and symptoms such as back pain, breathlessness, tiredness/weakness , dark-brown urine, fever, and yellow or pale skin, stop using ACZONE Gel, 7.5% and call your doctor right away.

The most common side effects of ACZONE Gel, 7.5% are dryness and itching of the skin being treated.


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