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.
Ortho Dermatologic’s ARAZLO is the first tazarotene acne treatment available in a lotion form, and has been shown to provide strong efficacy with favorable tolerability.
"Today's approval of ARAZLO showcases our continued commitment to expanding our acne portfolio to help the approximately 50 million Americans who are impacted by this prevalent skin condition," says Bill Humphries, president, Ortho Dermatologics, in a news release. "As our fourth FDA approval in just 14 months, ARAZLO will provide dermatologists 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. We are purposely timing the launch of ARAZLO to coincide with the start of acne season in the first half of 2020."
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 (≥1%) were application site pain, dryness, exfoliation, erythema and pruritus.
"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," adds Emil Tanghetti, MD, lead ARAZLO study investigator and founder, Center for Dermatology and Laser Surgery in Sacramento, CA. "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. I look forward to adding ARAZLO to my practice armamentarium."
ARAZLO Comprehensive Clinical Data
The FDA approval for ARAZLO was based on data from two Phase 3 multicenter, randomized, double-blind, vehicle-controlled clinical trials in 1,614 patients with moderate to severe acne. In both Phase 3 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 2, 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).