Critical Therapeutics to Initiate Clinical Study of Intravenous Formulation of Zileuton
Monday December 19, 5:45 pm ET
Phase I/II Asthma Study Scheduled to Begin in the First Quarter of 2006
LEXINGTON, Mass.--(BUSINESS WIRE)--Dec. 19, 2005--Critical Therapeutics, Inc. (Nasdaq: CRTX - News) today announced that the 30-day waiting period relating to the Company's Investigational New Drug application for the intravenous formulation of zileuton (zileuton IV) has ended. The Company plans to begin a Phase I/II study of zileuton IV in the United States in the first quarter of 2006. Critical Therapeutics owns worldwide rights to the zileuton franchise, including ZYFLO®, an FDA-approved oral tablet formulation that the Company is marketing in the United States for the prevention and chronic treatment of asthma in adults and children 12 years of age and older.
The Phase I/II study will assess the safety, tolerability, pharmacokinetics and exploratory efficacy of zileuton IV in patients with asthma. The double-blind, placebo-controlled, single-dose, multicenter study will be conducted in 60 patients with asthma and baseline FEV1 (forced expiratory volume), a lung-function measure, of 40%-80% of predicted normal. The study will mark the first time that zileuton IV has been tested in humans. As an oral product zileuton has been evaluated in clinical studies involving more than 5,000 asthma patients.
"Our clinical development program for zileuton IV is part of our plan to bring the complementary components of our zileuton franchise to the market in a focused and efficient manner," said Paul Rubin, M.D., president and chief executive officer of Critical Therapeutics. "Acute asthma is a common cause of emergency room (ER) visits and is responsible for approximately two million ER visits and nearly 500,000 hospital admissions in the United States annually. We believe that zileuton IV has the potential to benefit asthmatics who suffer from acute exacerbations. Clinical data demonstrates that oral zileuton's maximum effect on lung function correlates with blood drug concentration reaching peak level. As a result, we believe that the intravenous formulation may provide rapid onset of action because it could reach peak blood concentration rapidly following the time of injection."
About Zileuton and ZYFLO
Zileuton inhibits 5-lipoxygenase (5-LO), an enzyme that catalyzes the formation of leukotrienes from arachidonic acid. 5-LO is the main enzyme responsible for the production of leukotrienes, a family of inflammatory mediators that can trigger asthma symptoms including inflammation, swelling, bronchoconstriction and mucus secretion.
ZYFLO, the tablet formulation of zileuton, blocks the formation of leukotrienes. ZYFLO is indicated for the prevention and chronic treatment of asthma in adults and children 12 years of age and older. The recommended dose is one 600 mg tablet four times a day. ZYFLO is not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with ZYFLO can be continued during acute exacerbations of asthma. ZYFLO should be taken regularly, even during symptom-free periods.
ZYFLO Safety Information
Mild to moderate side effects associated with the use of ZYFLO are abdominal pain, upset stomach and nausea. A small percentage of patients treated with ZYFLO show an increased release of a liver enzyme known as ALT. As a result, the level of liver enzymes in patients treated with ZYFLO should be measured by a simple blood test. It is recommended that physicians perform this test before administering ZYFLO and repeat the test on a regular basis while patients are on the medication. ZYFLO is contraindicated in patients with active liver disease or transaminase elevations greater than or equal to three times the upper limit of normal.
For full prescribing information, please visit www.crtx.com/pat_pi.html or call the Company's toll free telephone number 1-866-835-8216 to request medical information. |
