The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for IDP-123 (tazarotene 0.045%) Lotion for the treatment of acne vulgaris.
The NDA includes data from two randomized, phase 3 trials involving 1614 patients with moderate to severe acne. The primary end points of the trials included absolute change in mean inflammatory and noninflammatory lesion counts at Week 12, as well as the percentage of patients who had ≥2 grade improvement from baseline to Week 12 in the Evaluator Global Severity Score and had “clear” or “almost clear” skin.
Results from the studies showed that treatment with tazarotene 0.045% lotion led to statistically significant improvements in both of these end points (P<.001). In addition, the treatment was found to be well-tolerated with application site pain, dryness, and exfoliation being the most commonly reported adverse events.
“If approved, IDP-123 will offer physicians and their patients a lower concentration of tazarotene in a lotion formulation,” said Bill Humphries, President of Ortho Dermatologics.
A Prescription Drug User Fee Act (PDUFA) target date of December 22, 2019 has been set for this application.
For more information visit ortho-dermatologics.com.