Zoryve (roflumilast)

Zoryve (roflumilast) is a topical, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor available in cream and foam formulations for the treatment of plaque psoriasis, atopic dermatitis (AD), and seborrheic dermatitis. FDA-approved indications vary by formulation, concentration, and patient age:

• Cream 0.3%: Plaque psoriasis, including intertriginous areas, in patients aged 2 years and older.

• Cream 0.15%: Mild to moderate AD in patients aged 6 years and older.

• Cream 0.05%: Mild to moderate AD in children aged 2 to 5 years.

• Foam 0.3%: Seborrheic dermatitis in patients aged 9 years and older and plaque psoriasis of the scalp and body in patients aged 12 years and older.

Roflumilast and its active metabolite, roflumilast N-oxide, inhibit PDE4, an enzyme involved in the breakdown of cyclic adenosine monophosphate (cAMP). PDE4 inhibition increases intracellular cAMP levels, which can modulate inflammatory signaling. The precise mechanism by which roflumilast produces its therapeutic effects is not fully established.

Zoryve is applied once daily to affected areas. The most commonly reported adverse reactions across clinical trials include headache, diarrhea, nausea, insomnia, application site pain, upper respiratory tract infection, urinary tract infection, vomiting, rhinitis, conjunctivitis, and nasopharyngitis, with frequencies varying by indication and formulation. Zoryve is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B or C).

For dermatologists, Zoryve offers a nonsteroidal topical option across several inflammatory skin conditions. Its once-daily dosing, multiple formulations, and approved pediatric indications provide flexibility when selecting treatment based on disease presentation, anatomic location, and patient age.