Revise Phase III protocol: CDSCO Panel Tells Mankind Over Roflumilast Cream

New Delhi: Responding to the proposal presented by Mankind Pharmaceutical to manufacture and market selective phosphodiesterase-4 inhibitor Roflumilast Cream 0.3% w/w, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to revise the protocol of the proposed drug in respect to the amount of drugs applied, specific time of application, specific criteria for randomization, specific lab tests to assess the side effects, etc.

This came after the firm presented their proposal for the manufacturing and marketing of Roflumilast Cream 0.3% w/w for the indication of topical treatment of plaque psoriasis, including treatment of psoriasis in the intertriginous areas, in patients 6 years of age and older with justification of bioequivalence (BE) waiver and phase III clinical trial protocol.

Roflumilast cream 0.3% is a once-daily phosphodiesterase-4 inhibitor that was recently approved by the FDA for the treatment of plaque psoriasis in adolescents and adults. It is indicated for use on all body surfaces, including intertriginous areas. It works by inhibiting phosphodiesterase-4 (PDE4), which is involved in inflammation. This makes it a non-steroidal option for treating psoriasis, offering a potential alternative to traditional steroid treatment

At the recent SEC meeting for dermatology and allergy held on 20th March 2025, the expert panel reviewed the proposal for the manufacturing and marketing of Roflumilast Cream 0.3% w/w for the indication of topical treatment of plaque psoriasis, including treatment of psoriasis in the intertriginous areas, in patients 6 years of age and older with justification of BE waiver and phase III clinical trial protocol.

After detailed deliberation, the committee opined that the firm should revise its protocol to include the following points:

1. Amount of drugs applied in terms of FTU on the affected area.

2. Specific time of application of the drug so that all the volunteers get uniform treatment

3. Specific criteria shall be adopted for randomization.

4. Instead of a placebo firm should use emollients

5. Specific lab tests shall be included to assess the side effects of the proposed drug.

6. Patients with moderate to severe psoriasis who are receiving other drug treatments shall be excluded from the study.

7. More number of geographically distributed sites, including proportional government sites, shall be included in the study.

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

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