Roflumilast foam to advance to phase 3 program for seborrheic dermatitis

Arcutis Biotherapeutics will begin a phase 3 trial of roflumilast foam for the treatment of seborrheic dermatitis, the company announced in a press release.

A once-daily topical foam formulation of a PDE4 inhibitor, roflumilast foam (ARQ-154) demonstrated statistically significant improvement in signs and symptoms of seborrheic dermatitis and scalp psoriasis compared with vehicle foam in phase 2 trials.

“Unlike creams and ointments, roflumilast foam is suitable for use in hair-bearing areas; unlike steroids, it is expected to be suitable for long-term use, including on the face; and unlike shampoos, it is an elegant, quick-drying, leave-in foam that doesn’t need to be rinsed out. If successful in the phase 3 clinical trial and approved for commercialization, roflumilast foam has the potential to become the standard of care in seborrheic dermatitis,” Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis, said in the release.

An end-of-phase 2 meeting with the FDA has been completed, and the single phase 3 trial is expected to begin in the second or third quarter of 2021.

The topical foam is also in development for the treatment of plaque psoriasis and atopic dermatitis.