Allergan Announces FDA Approval Of ACZONE (dapsone) Gel, 7.5% For Treatment Of Acne Vulgaris

February 26, 2016 |

6 min read

DUBLIN, Feb. 25, 2016 /PRNewswire/ -- Allergan plc (NYSE:AGN), a leading global pharmaceutical company, today 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.[1] 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.

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“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).²

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. For more information about the new ACZONE® Gel, 7.5%, providers can visit www.aczonehcp.com.

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.

Please see accompanying full Product Information: http://origin-qps.onstreammedia.com/origin/multivu_archive/ENR/337672-Allergan-plc.pdf

About Allergan
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women’s health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world’s third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.

For more information, visit Allergan’s website at www.Allergan.com.

Forward-Looking Statement
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan’s current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan’s current expectations depending upon a number of factors affecting Allergan’s business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan’s products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan’s periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2015 (such periodic public filings having been filed under the “Actavis plc” name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.