The U.S. Food and Drug Administration (FDA) has accepted Ortho Dermatologic’s New Drug Application for IDP-123 (tazarotene 0.045%) Lotion or acne with a PDUFA action date of Dec. 22, 2019.
If approved, IDP-123 will be the first tazarotene acne treatment available in a lotion form.
“Millions of Americans are affected by acne and, for many of these patients, it can be difficult to find a treatment that works for them,” says Bill Humphries, president, Ortho Dermatologics, in a news release. “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.”
The NDA submitted for IDP-123 includes data from two successfully completed Phase 3 randomized, placebo-controlled, double-blind clinical trials in 1,614 patients with moderate to severe acne. The primary efficacy endpoints included the absolute change in the mean non-inflammatory and inflammatory lesion counts, the percentage of subjects who had a least a two-grade improvement from baseline to week 12 in the Evaluator Global Severity Score (EGSS) and who had “clear” or “almost clear” skin. In both Phase 3 studies, all primary efficacy endpoints were met with statistical significance (p<.001). IDP-123 was also shown to be well-tolerated in the clinical study population. The most common adverse events were application site pain, application site dryness and application site exfoliation.