Ortho Derm Gets NDA for IDP-123 Lotion for Acne

Ortho Derm Gets NDA for IDP123 Lotion for Acne image

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.

Facebook Comments


We’re glad to see you’re enjoying PracticalDermatology…
but how about a more personalized experience?

Register for free