Zileuton drug data and news

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Critical Therapeutics on Target to Submit NDA for Zileuton ...  May 2, 2006
FDA) has accepted the Company's proposal to submit the New Drug Application (NDA) for its controlled-release (CR) formulation of zileuton with six months of ... - Genetic Engineering News,

Critical Therapeutics Reports First Quarter 2006 Financial Results ...  May 4, 2006
These reductions should provide additional capital to support the anticipated 2007 launch of the controlled-release (CR) formulation of zileuton. ... - Genetic Engineering News,

Critical Therapeutics, FDA Accepts Proposal For Submission Of New ...  May 2, 2006
Administration has accepted the company's proposal to submit the New Drug Application, NDA for its controlled-release or CR formulation of zileuton, a drug ... - Trading Markets,

Critical Therapeutics Says FDA Accepts Proposal To Submit NDA For ...  May 2, 2006
...that the US Food and Drug Administration has accepted its proposal to submit the New Drug Application for its controlled-release formulation of zileuton. ... - Trading Markets,

Highlights of rising and falling US stocks - UPDATE 2  May 2, 2006
...gained after the Lexington, Mass., firm said its proposal to submit a new drug application for its controlled-release formulation of zileuton was accepted by ... - Euro2day,

Critical Therapeutics Announces Schedule of Upcoming Investor ...  Apr 20, 2006
...care diseases. The Company owns worldwide rights to ZYFLO(R) (zileuton tablets), as well as other formulations of zileuton. ZYFLO ... - Genetic Engineering News,

Critical Therapeutics to Announce First-Quarter 2006 Financial ...  Apr 20, 2006
...diseases. The Company owns worldwide rights to the asthma drug ZYFLO(R) (zileuton tablets), as well as other formulations of zileuton. ... - PharmaLive.com (press release),

SkyePharma PLC - Preliminary Results Announcement for the Year ...  Apr 19, 2006
...in January 2006 that it had initiated two studies designed to support a New Drug Application for a twice-daily version of Zyflo(R) (zileuton), an oral ... - PR Newswire (press release),

In a drug-interaction study in 16 healthy volunteers, co-administration of multiple doses of zileuton (800 mg every 12 hours) and theophylline (200 mg every 6 hours) for 5 days resulted in a significant decrease (approximately 50%) in steady-state clearance of theophylline, an approximate doubling of theophylline A.C. and an increase in theophylline C_max (by 73%). The elimination half-life of theophylline was increased by 24%. Also, during co-administration, theophylline-related adverse events were observed more frequently than after theophylline alone. Upon initiation of ZYFLO in patients receiving theophylline, the theophylline dosage should be reduced by approximately one-half and plasma theophylline concentrations monitored. Similarly, when initiating therapy with theophylline in a patient receiving ZYFLO, the maintenance dose and/or dosing interval of theophylline should be adjusted accordingly and guided by serum theophylline determinations .

Concomitant administration of multiple doses of ZYFLO (600 mg every 6 hours) and warfarin (fixed daily dose obtained by titration in each subject) to 30 healthy male volunteers resulted in a 15% decrease in R-warfarin clearance and an increase in AUC of 22%. The pharmacokinetics of S-warfarin were not affected. These pharmacokinetic changes were accompanied by a clinically significant increase in prothrombin times. Monitoring of prothrombin time, or other suitable coagulation tests, with the appropriate dose titration of warfarin is recommended in patients receiving concomitant ZYFLO and warfarin therapy .

Co-administration of ZYFLO and propranolol results in a significant increase in propranolol concentrations. Administration of a single 80-mg dose of propranolol in 16 healthy male volunteers who received ZYFLO 600 mg every 6 hours for 5 days resulted in a 42% decrease in propranolol clearance. This resulted in an increase in propranolol C_max, AUC, and elimination half-life by 52%, 104%, and 25%, respectively. There was an increase in ß-blockade and decrease in heart rate associated with the co-administration of these drugs. Patients on ZYFLO and propranolol should be closely monitored and the dose of propranolol reduced as necessary. No formal drug-drug interaction studies between ZYFLO and other beta-adrenergic blocking agents (i.e., ß-blockers) have been conducted. It is reasonable to employ appropriate clinical monitoring when these drugs are co-administered with ZYFLO.

In a drug interaction study in 16 healthy volunteers, co-administration of multiple doses of terfenadine (60 mg every 12 hours) and ZYFLO (600 mg every 6 hours) for 7 days resulted in a decrease in clearance of terfenadine by 22% leading to a statistically significant increase in mean AUC and C_max of terfenadine of approximately 35%. This increase in terfenadine plasma concentration in the presence of ZYFLO was not associated with a significant prolongation of the QTc interval. Although there was no cardiac effect in this small number of healthy volunteers, given the high inter-individual pharmacokinetic variability of terfenadine, co-administration of ZYFLO and terfenadine is not recommended.

Drug-drug interaction studies conducted in healthy volunteers between ZYFLO and prednisone and ethinyl estradiol (oral contraceptive), drugs known to be metabolized by the P450 3A4 (CYP3A4) isoenzyme, have shown no significant interaction. However, no formal drug-drug interaction studies between ZYFLO and dihydropyridine, calcium channel blockers, cyclosporine, cisapride, and astemizole, also metabolized by CYP3A4, have been conducted. It is reasonable to employ appropriate clinical monitoring when these drugs are co-administered with ZYFLO.

Drug-drug interaction studies in healthy volunteers have been conducted with ZYFLO and digoxin, phenytoin, sulfasalazine, and naproxen. There was no significant interaction between ZYFLO and any of these drugs.