Ketoconazole foam--connetics: connetics ketoconazole foam.

Abstract

Connetics Corporation (USA) is developing a foam formulation of 2% ketoconazole [Extina] for the treatment of mycoses and dermatological indications, particularly seborrhoeic dermatitis. The product utilises Connetics' proprietary foam drug delivery technology, VersaFoam, and is currently awaiting registration in the US for the treatment of seborrhoeic dermatitis. Ketoconazole is a common antifungal used for the treatment of broad-spectrum mycoses, including Candida spp. Ketoconazole binds to fungal cytochrome P450 enzymes and inhibits cells from producing ergosterol, the main component of the cell wall. In late 2001, the initiation of clinical trials was delayed after Connetics decided to reformulate the foam to eliminate a particular ingredient derived from cows. In its 2001 Annual Report, Connetics stated that although the ingredient is acceptable in US products, the company felt that it was prudent to reformulate the product before beginning clinical trials. Connetics has already completed a pilot study comparing Extina with Nizoral in 50 patients with seborrhoeic dermatitis. The trial, while not sized for efficacy, did show strong efficacy trends in favour of Extina. This outcome was anticipated based on the advantages seen in skin permeation studies, which demonstrated that Extina penetrated the skin twice as effectively as Nizoral cream. The skin permeation studies were conducted by Connetics' Center for Skin Biology. Complete results from the skin permeation and pilot efficacy studies were to be submitted for publication in the second half of 2002. Results were also presented in March 2003 at the 61st Annual Meeting of the American Academy of Dermatology (AAD-2003). In July 2002, Connetics estimated the US market for topical antifungals to be worth approximately $US700 million annually.