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

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.

After detailed deliberation, the committee noted following facts:-