The US Food and Drug Administration (FDA) has awarded a New Drug Application for tazarotene (ARAZLO), a .045% topical lotion for acne vulgaris
The treatment, developed by Ortho Dermatologics, represents the first tazarotene acne treatment available in lotion form.
“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,” Bill Humphries, president, Ortho Dermatologics, said in a statement
. "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.”
The approval is based on a pair phase III multicenter, randomized, double-blind, vehicle-controlled clinical trials involving 1614 patients with moderate-to-severe acne. The primary efficacy endpoints in both studies were met with statistical significance (P
<.001) and the treatment was shown to be well-tolerated in the clinical study population.
The treatment, which is approved for patients at least 9 years old, is expected to be available during the first half of 2020.
Retinoids are often a core component of most acne treatments, but often cause skin irritation.
In a head-to-head phase II study, the new lotion had a similar efficacy as Tazorac (tazarotene) Cream 0.1%, with approximately half of the adverse events. The most frequent reported adverse events with the new lotion were application site pain, dryness, exfoliation, erythema, and pruritus.
The topical lotion showed similar treatment success to the cream, with similar reductions in both inflammatory and non-inflammatory lesions over 12 weeks.
“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, lead ARAZLO study investigator and founder, Center for Dermatology and Laser Surgery, said in a statement. "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.”