April 18, 2023
1 min read
- The FDA will review a new drug application for roflumilast foam 0.3% to treat seborrheic dermatitis in patients aged 9 years and older.
- The prescription drug user free target action date is Dec. 16.
The FDA has accepted for review a new drug application for roflumilast foam 0.3% for seborrheic dermatitis treatment in patients aged 9 years and older, Arcutis announced in a press release.
“Given there has been no new topical drug with a new mechanism of action for seborrheic dermatitis in over 2 decades, the acceptance by the FDA of our new drug application is an exciting milestone for those living with seborrheic dermatitis,” Patrick Burnett, MD, PhD, FAAD, senior vice president and chief medical officer at Arcutis, told Healio. “If approved, roflumilast foam has the potential to meet an urgent need for a new steroid-free therapy designed to enable symptom control, easier management and increased adherence.”
Roflumilast cream is currently approved to treat plaque psoriasis in adults and adolescents.
The new drug application (NDA) is supported by STRATUM, a pivotal phase 3, parallel group, double-blind, vehicle-controlled study in which roflumilast foam attained its primary endpoint, with an IGA success rate of 79.5% vs. 58% in vehicle (P < .0001).
Roflumilast foam also showed statistically significant improvement over vehicle in all secondary endpoints compared with vehicle, including measurements in itch response by week 8 (62.8% vs. 40.6%; P = .0001).
The trials showed a favorable safety and tolerability profile with a low rate of treatment-emergent adverse events that was comparable between the study drug and vehicle. No treatment-related serious adverse events were reported.
The FDA assigned the NDA a prescription drug user free act target action date of Dec. 16, according to the release.