FDA approves Arazlo for the topical treatment of Acne. Ortho Dermatologics/Bausch

Bausch Health Companies Inc. and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, announced that the FDA has approved the New Drug Application for Arazlo (tazarotene) Lotion, 0.045%, for the topical treatment of acne vulgaris in patients nine years of age and older. Arazlo is the first tazarotene acne treatment available in a lotion form, and has been shown to provide strong efficacy with favorable tolerability.

The FDA approval for Arazlo was based on data from two Phase III multicenter, randomized, double-blind, vehicle-controlled clinical trials in 1,614 patients with moderate to severe acne. In both Phase III studies, all primary efficacy endpoints were met with statistical significance (p<.001). arazlo was also shown to be generally well-tolerated in the clinical study population. in a phase ii, head-to-head study, arazlo and tazorac (tazarotene) cream 0.1% showed similar treatment success rates and similar reductions in both inflammatory and non-inflammatory lesions over 12 weeks. while there were no significant differences in patient satisfaction or quality of life between the two treatments and both were well-tolerated, there were numerically about double the number of treatment-related adverse events with tazorac (5.6 percent with tazorac versus 2.9 percent with arazlo).>

Comment: Retinoids like tazarotene are a core component of acne treatment. However, a common barrier to their use is that treatment with retinoids is often associated with skin irritation, such as dryness. In a head-to-head study, Arazlo demonstrated similar efficacy as Tazorac (tazarotene) Cream 0.1% with about half the adverse events. The most frequent adverse events reported with Arazlo ( greater than 1%) were application site pain, dryness, exfoliation, erythema and pruritus.