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news.Critical Therapeutics has announced positive results from its phase I/II clinical trial evaluating the safety, tolerability and pharmacokinetics intravenous zileuton in patients with asthma. In addition, evidence of improved lung functioning was detected, the company reported.
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The double-blind, placebo-controlled trial enrolled 60 patients at 10 clinical sites in the US. Patients enrolled in the trial had a mean FEV1 (forced expiratory volume in one second) of 63% of predicted normal at baseline and a mean age of 40 years.
Patients enrolled in the trial were randomized into four escalating dose groups, each receiving one infusion of either the intravenous formulation of zileuton (zileuton IV) or placebo. Each of the four dose groups enrolled 15 patients, of whom 12 received zileuton IV and three received placebo.
The 300mg dose was predicted to approximate the currently approved oral dose of Zyflo (zileuton tablets). In this trial, the 300mg dose group showed a mean improvement in FEV1 from a baseline of 13.7% at 60 minutes after dosing.
In addition, zileuton IV was well tolerated at all doses tested with no serious adverse events reported in the trial.
Critical Therapeutics is developing zileuton IV initially for use in emergency room or urgent care centers for patients who suffer acute exacerbations of asthma.
“I believe that the results from this phase I/II trial are promising and support the further development of the drug for patients suffering acute exacerbations of asthma,” stated Lyndon Mansfield, director of Western Sky Medical Research in El Paso, Texas.
“I am particularly encouraged about the opportunities for zileuton IV in emergency and urgent care settings where there has not been a new treatment paradigm in a number of years,” he added.