Tazarotene topical for acne vulgaris launches in United States

June 25, 2020

Tazarotene lotion 0.045% (Arazlo, Ortho Dermatologics) is officially launched in the U.S. following approval by the U.S. Food and Drug Administration in late 2019 for the treatment of acne vulgaris in patients 9 years and older.

Tazarotene lotion 0.045% (Arazlo, Ortho Dermatologics) is now available in the United States for treatment of acne vulgaris with the recent announcement from Bausch Health Companies, Inc. and its dermatology business Ortho Dermatologics. The drug, approved by the U.S Food and Drug Administration in December 2019 in patients 9 years and older, is the first lotion formulation of tazarotene.1

While retinoids, like tazarotene, have proven to be an effective treatment for acne, some have shied away from its use due to various side effects including scaling, erythema, pruritus, dryness and burning. However, data for tazarotene lotion have demonstrated good tolerability among patients.

MORE: Tazarotene lotion shows positive phase 3 results

"Retinoids like tazarotene are highly effective in treating acne and considered a cornerstone of acne treatment, but often are perceived to be associated with skin irritation. Clinical studies have demonstrated that ARAZLO's proprietary formulation provides the proven efficacy of a retinoid in a lotion that is more tolerable to patients than a higher concentration tazarotene," says Bill Humphries, president of Ortho Dermatologics. "Ortho Dermatologics remains committed to bringing forward new treatment options like ARAZLO to help the millions of Americans who suffer from acne."

The approval is supported by data from two phase 3 randomized, double-blind, multicenter, vehicle-controlled clinical trials that investigated the safety, efficacy and tolerability of tazarotene lotion 0.045% in 1,614 patients with moderate-to-severe acne vulgaris over 12 weeks.

As previously reported by Dermatology Times, both studies met all primary endpoints including absolute reduction in non-inflammatory and inflammatory lesions counts, and a minimum of a two-grade improvement in the Evaluator’s Global Severity Score (EGSS).2

RELATED: Better Safety profile for new retinoid in development

Additionally, data from the studies demonstrate a statistically higher success rate for reducing inflammatory and noninflammatory lesions in those using tazarotene 0.045% compared to vehicle. Mean percentages were 55.5% and 51.4% (Study 1, both P<0.001 versus vehicle [45.7% and 41.5%, respectively]) and 59.5% and 60.0% (Study 2, both P<0.001 versus vehicle [49.0% and 41.6%, respectively]), with tazarotene 0.1% cream at week 12.3

While the drug was generally well-tolerated, some of the most common treatment-related adverse events included pain (5.3%), dryness (3.6%) and exfoliation (2.1%), the study authors note.3

"The novel lotion formulation of ARAZLO has been shown to be generally well-tolerated, allowing more patients with multiple types of acne to take advantage of its efficacy," says Emil Tanghetti, M.D., lead ARAZLO study investigator and founder of the Center for Dermatology and Laser Surgery, Sacramento, Calif. "I am excited to offer ARAZLO to my patients and anticipate they will be pleased with their results."

References:

1. BioSpace. (2020, June 23). Ortho Dermatologics Launches ARAZLO™ (tazarotene) Lotion, 0.045%, In The United States. Retrieved June 25, 2020, from https://www.biospace.com/article/releases/ortho-dermatologics-launches-arazlo-tazarotene-lotion-0-045-percent-in-the-united-states/.

2. Hobbins, K., & Petronelli, M. (2020, January 16). Tazarotene lotion shows positive phase 3 results. Retrieved June 25, 2020, from https://www.dermatologytimes.com/view/tazarotene-lotion-shows-positive-phase-3-results.

3. Tanghetti EA, Werschler WP, Lain TP, Guenin Eundefined, Martin Gundefined, PhDe Rundefined. (2020, January) Article. JDDonline. Accessed June 25, 2020. https://jddonline.com/articles/dermatology/S1545961620P0070X/1.