The phase I/II clinical trial is designed to evaluate the IV formulation’s safety, tolerability, pharmacokinetics and preliminary efficacy in 60 patients, pre-screened for response to oral zileuton, whose baseline lung function is 40%-80% of predicted normal, as measured by FEV1 (forced expiratory volume).
It is the first time an IV formulation of a 5-lipoxygenase inhibitor has been tested in humans. By initiating the clinical trial in patients, the company should be able to gain insights into the drug’s effect on lung function.
“This trial is our first clinical step toward developing IV zileuton as an additional therapy for emergency room management of acute asthma – an area that has not had any new treatment options in a number of years,” said Dr Paul Rubin, president and CEO of Critical Therapeutics.
As an oral drug, zileuton has been studied in clinical trials involving more than 5,000 asthma patients. In October 2005, Critical Therapeutics began marketing ZYFLO, a four-times-per-day tablet formulation of zileuton, in the US for the prevention and chronic treatment of asthma in patients 12 years of age and older.