FDA accepts new drug application for tazarotene lotion

August 19, 2019

The U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for Ortho Dermatologics’ novel tazarotene O.045% lotion (IDP-123) with a PDUFA action date of Dec. 22, 2019, according a recent announcement from the company.

The U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for Ortho Dermatologics’ novel tazarotene O.045% lotion (IDP-123) with a PDUFA action date of Dec. 22, 2019, according a recent announcement from the company.

If approved, IDP-123, will be the first tazarotene lotion available to treat acne.

“Current gel, foam, or cream formulations can cause irritation, limiting their use,” says one of the trial investigators, Emil Tanghetti, M.D., Center for Dermatology and Laser Surgery, “A new tazarotene 0.045% lotion formulation, for the treatment of acne vulgaris, was developed utilizing polymeric emulsion technology to provide uniform distribution of drug and emollient in a non-greasy vehicle that is convenient to use.”

The NDA included data from two successfully completed phase 3 randomized, placebo-controlled, double-blind clinical trials containing 1,614 patients with moderate-to-severe acne.

“In recent pivotal studies, this lotion was shown to have significantly greater efficacy related to vehicle in achieving treatment success, which was defined as absolute mean reduction of inflammatory and non-inflammatory lesions, as well as at least a two-grade improvement from baseline in a global severity by Evaluator Global Severity Score (EGSS) and ‘clear’ or ‘almost clear’ skin,” says Dr. Tanghetti. “This 0.045% tazarotene lotion appears as a potential new option for the treatment  of acne vulgaris with the efficacy that we are used to seeing with tazarotene cream but with a favorable tolerability profile.”

“If approved, IDP-123 will offer physicians and their patients a lower concentration of tazarotene in a lotion formulation, helping to further expand upon our growing portfolio of acne treatments,” said Bill Humphries, president, Ortho Dermatologics.