In addition, the FDA has approved the enrollment in the study of patients with mastocytosis, an orphan disease involving new or abnormal cell growth, where Zyflo (zileuton tablets) is deemed essential for the treatment of symptoms.
Zyflo is the only 5-lipoxygenase inhibitor approved in the US for the treatment of asthma in adults and children 12 years of age and older. Critical Therapeutics licensed exclusive worldwide rights to Zyflo and other forms of zileuton from Abbott Laboratories and is in the process of transferring the manufacturing to new sites.
The company expects to submit a supplemental new drug application (sNDA) to the FDA for the change in manufacturing process and sites and, subject to FDA approval of these new manufacturing sites, expects Zyflo to be commercially available in the fourth quarter of 2005. Zyflo has been commercially unavailable since early 2004, when Abbott Laboratories’ remaining supply was depleted.
“We are pleased to be allowed to begin this open-label study, as it enables us to fulfill many requests from physicians and previous asthma patients who responded to Zyflo and require continued therapy to control their asthma,” said Dr Paul Rubin, president and CEO of Critical Therapeutics. “For patients who have previously benefited from Zyflo, this study serves as an important bridge until approval and commercial availability.”
Trial enrollment will proceed until Critical Therapeutics receives authorization from the FDA to market Zyflo in the US, or until 18 months have lapsed, whichever occurs first.