Quinnova Pharmaceuticals LLC, an affiliate of Exeltis, launched its recently FDA-approved Ecoza (econazole nitrate) topical foam 1%. Ecoza Foma is indicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years of age and older.
Ecoza Foam, according to the company, combines the proven antifungal efficacy of econazole nitrate with the skin-restoring properties of Proderm Technology. Proven to kill fungi that cause interdigital tinea pedis when applied once-daily for four weeks, its unique, alcohol-free foam delivery helps protect and restore skin, penetrating quickly and drying rapidly without the greasy residue that is common among other creams and gels.
In two double-blind, parallel-group, vehicle-controlled, multicenter clinical trials, 495 subjects aged ≥12 years with a clinical diagnosis of interdigital tinea pedis and fungal culture positive for a dermatophyte at baseline received Ecoza Foam (n=246) or foam vehicle (n=249). Subjects applied Ecoza Foam or foam vehicle once-daily for four weeks. The primary endpoint was proportion of subjects who achieved a complete cure (negative KOH, negative fungal culture, no evidence of clinical disease as indicated by complete resolution of all signs and symptoms) at two weeks post-treatment (Day 43). Secondary endpoints included mycologic cure (negative KOH and negative culture) and effective treatment (mycologic cure + no or mild erythema and/or scaling and all other signs and symptoms absent).
The results from the clinical studies demonstrated that Ecoza 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 Day 43 (two weeks post-treatment) was higher in the Ecoza Foam group (24.3 percent) than in the foam vehicle group (3.6 percent). In addition, higher rates of mycologic cure (67.6 percent vs 16.9 percent) and effective treatment (48.6 percent vs 10.8 percent) were observed with econazole nitrate foam 1% vs the foam vehicle. Ecoza Foam was safe and well tolerated with a safety profile comparable with the foam vehicle. During clinical trials, the most common adverse reactions were application site reactions, which occurred in less than 1 percent of subjects in both the Ecoza Foam and vehicle arms.
"We are really excited about the launch of Ecoza Foam, the first and only FDA approved prescription econazole nitrate foam in the US, into the almost $600M global athletes foot market. Econazole nitrate is a safe and effective topical antifungal, having been one of the most widely prescribed for the past two decades. This dosage form, using our patented Proderm Technology that consists of a unique chemical structure that facilitates penetration of drug ingredients into the dermal layer, addresses an unmet consumer need because it is easy to apply, quickly disperses, and does not leave a residue," said Jeffrey S. Day, Executive Vice President, Dermatology of Quinnova Pharmaceuticals. "We are pleased that Ecoza Foam is now available to offer doctors and their patients a safe and effective alternative to traditional creams and gels."