Ecoza (Econazole Nitrate) Topical Foam Launched for Treatment of Athlete’s Foot
Product approved for patients aged 12 years and older
Quinnova Pharmaceuticals has announced the launch of Ecoza (econazole nitrate) topical foam, 1%, which was approved by the FDA in October 2013 for the treatment of interdigital tinea pedis (athlete’s foot) caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years of age and older.
Ecoza topical foam should be applied to cover affected areas once daily for 4 weeks. The product is for topical use only and is not for oral, ophthalmic, or intravaginal use.
In two double-blind, parallel-group, vehicle-controlled clinical trials, a total of 495 subjects aged 12 years and older with a clinical diagnosis of interdigital tinea pedis and with fungal culture positive for a dermatophyte at baseline received econazole nitrate foam (n = 246) or foam vehicle (n = 249). The subjects applied the active foam or the vehicle once daily for 4 weeks.
The study’s primary endpoint was the proportion of subjects who achieved a complete cure (defined as a negative potassium hydroxide [KOH] test, negative fungal culture, and no evidence of clinical disease) at 2 weeks post-treatment (day 43). Secondary endpoints included mycologic cure (a negative KOH test and negative culture) and effective treatment (a mycologic cure and no or mild erythema and/or scaling, and all other signs and symptoms absent).
In these clinical studies, econazole nitrate foam exhibited superiority over foam vehicle for the primary and secondary endpoints and demonstrated potent antifungal activity against all of the pathogens evaluated, with a high mycologic cure rate. The complete cure rate at 2 weeks post-treatment (day 43) was higher in the group treated with econazole nitrate foam (24.3%) than in the group given foam vehicle (3.6%). In addition, higher rates of mycologic cure (67.6% vs 16.9%) and effective treatment (48.6% vs 10.8%) were observed with econazole nitrate foam compared with the foam vehicle.
Econazole nitrate foam was safe and well tolerated, with a safety profile comparable with that of the foam vehicle. During clinical trials with econazole nitrate foam, the most common adverse effects were application-site reactions, which occurred in less than 1% of subjects in both the active-treatment and vehicle arms.
Econazole nitrate, an azole antifungal agent, inhibits fungal cytochrome P450-mediated 14 alpha-lanosterol demethylase enzyme. This enzyme converts lanosterol to ergosterol. The accumulation of 14 alpha-methyl sterols correlates with the subsequent loss of ergosterol in the fungal cell wall and may be responsible for the fungistatic activity of econazole.