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news.Health Canada has granted approval for Arcutis’ topical formulation Zoryve (roflumilast cream 0.15%) for mild to moderate atopic dermatitis (AD) treatment in adults and paediatrics aged six years and above.
The cream formulation does not disrupt the barrier of the skin. Credit: Ana Essentiels on Unsplash.
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This one-time-day cream claims to offer a non-steroidal alternative that is tailored for quick relief from itch and inflammation, with a suitability for long-term usage.
Arcutis Canada general manager and vice president Jamie Lewis said: “We are proud to offer Canadians as young as six years old a new steroid-free option for managing atopic dermatitis that is grounded in both patient needs and clinical evidence.
“Zoryve cream 0.15% represents our commitment to providing innovative solutions that address the key challenges faced by patients and healthcare providers.”
Formulated with HydroARQ Technology, the non-greasy, emollient cream has rapid absorption.
This formulation is particularly beneficial for AD individuals as it does not disrupt the barrier of the skin. It is designed to align with the skin’s physiological potential of hydrogen (pH) and is free from potential sensitising excipients and irritants such as polyethylene glycol, isopropyl alcohol, propylene glycol, ethanol, or fragrances, which could aggravate skin sensitivity.
The approval of Zoryve cream for AD was based on the outcomes from the Phase III INTEGUMENT-1 and INTEGUMENT-2 trials.
Further data from a Phase II dose-ranging trial, an open-label extension trial (INTEGUMENT-OLE), and two Phase I pharmacokinetic trials backed the approval.
Clinical trials have generally shown that Zoryve cream is well tolerated.
In addition to the AD indication, roflumilast cream 0.3% is authorised in Canada for the topical treatment of plaque psoriasis, including intertriginous areas, in individuals aged 12 and above.
Moreover, a lower dose of roflumilast cream (0.05%) is currently under evaluation for treating children aged two to five years with atopic dermatitis.
Furthermore, the Canadian regulator has also authorised the use of Zoryve for treating seborrheic dermatitis in individuals aged nine years and above.
