Submit adequate justification: CDSCO Panel tells Synokem pharma about Phase III CT of Naftifine Cream

Published On 2022-10-26 06:15 GMT | Update On 2022-10-26 06:15 GMT

New Delhi: Regarding the ongoing Phase III Clinical trial with the drug Naftifine HCI Cream 2%w/w, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined drug major Synokem Pharma to submit the adequate justification/rationale for the proposed un-blinding of randomization and interim analysis of data before the committee. This...

New Delhi: Regarding the ongoing Phase III Clinical trial with the drug Naftifine HCI Cream 2%w/w, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined drug major Synokem Pharma to submit the adequate justification/rationale for the proposed un-blinding of randomization and interim analysis of data before the committee.

This came after the firm presented their proposal for the un-blinding of randomization and interim analysis of data of all patients after completing the visit 4 (i.e. Day 42±3 days/week 6) of the ongoing Phase III Clinical trial with the drug Naftifine HCI Cream 2%w/w.

A 'blind' study is a clinical trial in which the subject or the Investigator (or both) are unaware of which trial product/drug the subject is taking. When only one is blinded to the data this is a 'single blind' study. When both do not know the treatment, the study is 'double-blind'. Studies in which the participant takes part in three arms, such as placebo, active drug and comparative drug remain as double blind.

Unblinding is the process by which the allocation code is broken so that the Clinical trial investigator (CI) and/or trial statistician becomes aware of the intervention.

Naftifine is a synthetic, broad spectrum, antifungal agent and allylamine derivative for the topical treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans and Epidermophyton floccosum.

Although the exact mechanism of action against fungi is not known, naftifine appears to interfere with sterol biosynthesis by inhibiting the enzyme squalene 2,3-epoxidase. This inhibition of enzyme activity results in decreased amounts of sterols, especially ergosterol, and a corresponding accumulation of squalene in the cells.

At the recent SEC meeting for Dermatology and Allergy held on October 13th,2022 the expert panel extensively evaluated the proposal presented by Synokem Pharma for the un-blinding of randomization and interim analysis of data of all patients after completing the visit 4 (i.e. Day 42±3 days/week 6) of the ongoing Phase III Clinical trial with the drug Naftifine HCI Cream 2%w/w

After detailed deliberation, the committee opined that the firm should submit the adequate justification/rationale for the proposed un-blinding of randomization and interim analysis of data before the committee for further consideration of the matter.

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Dr. Divya Colin

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

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Submit adequate justification: CDSCO Panel tells Synokem pharma about Phase III CT of Naftifine Cream

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