FDA OKs First Tazarotene Lotion (Arazlo) for Acne Vulgaris

Megan Brooks

December 19, 2019

The US Food and Drug Administration (FDA) has approved tazarotene lotion 0.045% (Arazlo, Ortho Dermatologics) to treat acne vulgaris in individuals aged 9 years and older.

Arazlo is the first tazarotene acne treatment available in lotion form, and has been shown to provide "strong efficacy with favorable tolerability," the company said in a news release.

Tazarotene lotion has the "efficacy expected of tazarotene in a new formulation that helps minimize the dryness and irritation historically associated with tazarotene use, which can cause many acne patients to discontinue treatment," Bill Humphries, president of Ortho Dermatologics, said in the release.

In approving tazarotene lotion, the FDA reviewed data from two phase 3 multicenter, randomized, double-blind, vehicle-controlled clinical trials involving more than 1600 people with moderate to severe acne. In both studies, tazarotene lotion was generally well-tolerated and all primary efficacy endpoints were met with statistical significance (P < .001).

In a phase 2 head-to-head comparative study, tazarotene 0.045% lotion showed similar efficacy as tazarotene 0.1% cream with fewer side effects. There were no significant differences in patient satisfaction or quality of life between the two treatments and both were well-tolerated, but there were numerically about double the number of treatment-related adverse events with the cream (Tazorac) vs the lotion (5.6% vs 2.9%), the company said.

"Many of my patients with moderate to severe acne can benefit from the efficacy of tazarotene, but struggle to stay on treatment due to tolerability issues," Emil Tanghetti, MD, study investigator and founder of the Center for Dermatology and Laser Surgery in Sacramento, California, said in the release.

"Tazarotene has typically been reserved only for patients with severe acne, but offering it in a well-tolerated lotion formulation that includes hydrating agents can help more patients with most types of acne take advantage of its efficacy," he added.

The company expects to launch the medication in the first half of 2020.

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