Conduct bridging CT, prove efficacy, safety: CDSCO Panel Tells Glenmark on Roflumilast Cream of additional strength, indication

New Delhi: Citing that Glenmark Limited should conduct bridging clinical trials to prove the efficacy and safety of the Roflumilast Cream 0.3%w/w (additional strength and indication) on the Indian population, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined to submit Phase-III clinical trial protocol to CDSCO for further review by the committee.

This came after Glenmark Limited presented the proposal for a grant of permission to manufacture and marketing of Roflumilast cream 0.3%w/w(additional strength & indication) along with justification and comparative in-vitro bioequivalence data between Glenmark’s test product and reference product (ZRYVE Cream) and requested for waiver of Phase-III clinical trial & Bio-equivalence study before the committee.

The firm informed that the proposed formulation Roflumilast topical cream 0.3%w/w was already approved in the USA on 29.06.2022 and Canada on 27.04.2023 for the same indication.

Roflumilast topical cream is used to treat plaque psoriasis, which is a form of skin disease with red patches and white scales that do not go away. It is also used to treat seborrheic dermatitis. Plaque psoriasis is a chronic dermatologic autoimmune disease that affects adults and children. Roflumilast 0.3% cream is currently the only topical phosphodiesterase 4 inhibitor indicated for the treatment of plaque psoriasis in patients 12 years or older.

Roflumilast inhibits the phosphodiesterase 4 inhibitor enzyme leading to the accumulation of cyclic adenosine monophosphate, which suppresses the inflammatory mediators interferon-γ and tumor necrosis factor-α.

At the recent SEC meeting for the Dermatology and Allergy held on 16th April 2024, the expert panel reviewed the proposal for grant of permission to manufacture and marketing of Roflumilast cream 0.3%w/w (additional strength & indication) along with justification and comparative in-vitro bioequivalence data between Glenmark’s test product and reference product (ZRYVE Cream) and request for waiver of Phase-III clinical trial and Bio-equivalence study before the committee.

After detailed deliberation, the committee recommended that the firm should conduct bridging clinical trials to prove the efficacy and safety of the proposed formulation on the Indian population.

Accordingly, the expert panel suggested that the firm should submit the Phase-III clinical trial protocol to CDSCO for further review by the committee.

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