Synokem Pharama gets CDSCO panel nod to manufacture, market Naftifine HCL Cream 2%

Written by Dr. Divya Colin Published On 2022-12-22T18:00:39+05:30 | Updated On 22 Dec 2022 6:00 PM IST

Synokem Pharama gets CDSCO panel nod to manufacture, market Naftifine HCL Cream 2%

New Delhi: The drug major Synokem Pharmaceutical has got green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the antifungal drug Naftifine HCL Cream 2% w/w for the treatment of superficial fungal infection of the skin.

This came after the firm presented the Phase III clinical trial report of the antifungal drug Naftifine HCL Cream 2% w/w before the committee.

Naftifine is a synthetic, broad-spectrum antifungal agent and allylamine derivative used in the topical treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, and Epidermophyton floccosum. It has been shown to exhibit fungicidal activity in vitro against a broad spectrum of organisms including Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Epidermophyton floccosum, and Microsporum canis, Microsporum audouini, and Microsporum gypseum.

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.

Naftifine comes as a cream or gel to apply topically to the skin. The cream is usually used once a day and the gel twice a day in the morning and evening, for 2 to 4 weeks.

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

Earlier, the Medical Dialoges Team had reported that 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) had opined Synokem Pharma to submit the adequate justification/rationale for the proposed un-blinding of randomization and interim analysis of data before the committee.

Now, in continuation, at the recent SEC meeting for Dermatology and Allergy dated 15th December 2022, the expert panel reviewed the Phase III clinical trial report of the antifungal drug Naftifine HCL Cream 2% presented by drug major Synokem Pharmaceutical.

After detailed deliberation, the committee noted following facts:-

1. Naftifine HCL Cream 2% w/w cream is already approved for manufacture and market in the country on 09.11.2022.

2. Total 218 male and female patients aged between 18 to 65 years were screened, 198 randomized, and 193 completed the study.

3. Total 24 adverse effects (AEs) were reported in 24 patients. 11 AEs were reported in test product arm i.e., Naftifine Hydrochloride Cream 2% w/w and 13 AEs were reported in reference product arm i.e., Miconazole Nitrate Cream 2% w/w. All the AEs were mild in nature.

4. No Serious Adverse Event (SAE) was reported during the study.

5. The patients in test arm i.e. Naftifine Hydrochloride Cream 2% w/w and reference arm i.e.. Miconazole Nitrate Cream 2% w/w showed a clinical cure. Both the treatments were well tolerated.

6. The difference in proportion of patients showing clinical cure between the test arm i.e. Naftifine Hydrochloride Cream 2% w/w and reference arm i.e. Miconazole Nitrate Cream 2% w/w lies within the defined non-inferiority margin.

In accordance with the above observation, the committee recommended the grant of permission to manufacture and market the drug Naftifine Hydrochloride Cream 2% w/w for the treatment of superficial fungal infection of the skin (Tinea corporis and Tinea Cruris).

Also Read:Submit Phase IV CT protocol: CDSCO Panel tells Roche over Anti-Cancer drug Pralsetinib

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Dr. Divya Colin

Doctor of Pharmacy

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.