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Zoryve (roflumilast) - 2 indications
Scroll down for more information on each indication:
- for the topical treatment of plaque psoriasis; approved July of 2022
- for the topical treatment of seborrheic dermatitis; approved December of 2023
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 6 years of age and older (Zoryve cream).
- for the treatment of seborrheic dermatitis in individuals 9 years of age and older (Zoryve foam).
Zoryve is supplied as a cream and a foam 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
Indication 1 - Plaque psoriasis (cream)
approved July of 2022
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.
Indication 2 - seborrheic dermatitis (foam)
approved December of 2023
The FDA approval of Zoryve foam was based on phase 2 and pivotal Phase 3 trials in seborrheic dermatitis. The STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM) and the Phase 2 (Trial 203) were parallel group, double-blind, vehicle-controlled studies evaluating the safety and efficacy of Zoryve foam 0.3% in seborrheic dermatitis. Together the two studies enrolled 683 adults and adolescents ages 9 years and older.
The STRATUM study met its primary endpoint, with nearly 80% of Zoryve foam treated individuals reaching Investigator Global Assessment (IGA) Success rate at Week 8 (79.5% Zoryve foam vs 58.0% vehicle; P<0.0001). In Trial 203, 73% of individuals treated with Zoryve foam achieved IGA Success (73.1% Zoryve foam vs 40.8% vehicle; P<0.0001.) IGA Success was defined as an IGA score of “Clear” (0) or “Almost Clear” (1), plus a 2-grade IGA score improvement from baseline at Week 8.
Improvement with Zoryve foam was seen early, with roflumilast demonstrating a statistically significant improvement compared to vehicle on IGA Success at Week 2, the first timepoint assessed in STRATUM. In addition, 50.6% of individuals in the Zoryve foam treated arm reached complete clearance (IGA=0) at Week 8.
The STRATUM study also demonstrated statistically significant improvement over vehicle on all secondary endpoints, including itch, scaling, and erythema (redness). More than 60% of individuals achieved a ≥4-point reduction in itch at Week 8 as measured by Worst Itch-Numerical Rating Score (62.8% roflumilast foam vs 40.6% vehicle; P=0.0001), and significant improvements in itch were also reported at Week 2 and Week 4. Individuals treated with Zoryve foam reported a 28% improvement in itch from baseline in 48 hours (compared to 13% on vehicle nominal P=0.0024).
In addition, more than 50% of individuals treated with Zoryve foam achieved an erythema (redness) score of 0, and more than 50% achieved a scaling score of 0, at Week 8. Treatment with Zoryve foam demonstrated a significantly larger improvement in patient reported outcomes as early as Week 2 as measured through Dermatology Life Quality Index (DLQI), with improvements maintained through Week 8.