General Information

Zoryve (roflumilast) is a phosphodiesterase 4 (PDE4) inhibitor.

Zoryve is specifically indicated for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

Zoryve is supplied as a cream for topical administration. Apply Zoryve to affected areas once daily and rub in completely. Wash hands after application, unless Zoryve is for treatment of the hands.

Mechanism of Action

Zoryve (roflumilast) is a phosphodiesterase 4 (PDE4) inhibitor. Roflumilast and roflumilast N-oxide inhibition of PDE4 (a major cyclic 3′,5′-adenosine monophosphate (cyclic AMP) metabolizing enzyme) activity leads to accumulation of intracellular cyclic AMP. The specific mechanism(s) by which roflumilast exerts its therapeutic action is not well defined.

Side Effects

Adverse effects associated with the use of Zoryve cream may include, but are not limited to, the following:

• diarrhea
• headache
• insomnia
• application site pain
• upper respiratory tract infections
• urinary tract infections

Clinical Trial Results

The FDA approval of Zoryve cream was based on comprehensive results from the pivotal DERMIS-1 and DERMIS-2 (trials of PDE4 inhibition with Roflumilast for the Management of plaque psoriasIS One and Two) Phase 3 studies. In these trials, significantly more patients treated with Zoryve achieved Investigator Global Assessment (IGA) success at Week 8 compared to vehicle (42% in DERMIS-1 and 37% in DERMIS-2 with Zoryve compared to 6% in DERMIS-1 and 7% in DERMIS-2 with vehicle. IGA success is defined as an IGA score of clear (0) or almost clear (1), plus a ≥2-grade IGA score improvement from baseline.

Zoryve improved the severity and impact of itch, as early as Week 2. Two-thirds of patients with a Worst Itch-Numerical Rating Score (WI-NRS) of 4 or higher at baseline achieved a > 4-point reduction in itch at Week 8 with Zoryve (67% vs. 26% in DERMIS-1 and 69% vs. 33% in DERMIS-2 at Week 8.

Zoryve is the only topical for which efficacy has been specifically demonstrated in the treatment of intertriginous psoriasis, as measured by Intertriginous IGA (I-IGA) Success (72% vs. 14% in DERMIS-1 and 68% vs. 17% in DERMIS-2 at Week 8.

Of 239 individuals who continued treatment with Zoryve for at least 52 weeks in an open-label long-term safety trial, 45% were evaluated as an IGA of “Clear” or “Almost Clear” at Week 52.