Critical Therapeutics and Dey Launch Twice-Daily ZYFLO CR(TM) (Zileuton) Extended-Release Tablets.240-person Sales Force Begins Rollout to 18,000 Respiratory Specialists and Primary Care Physicians Throughout the U.S. LEXINGTON, Mass. -- Critical Therapeutics, Inc. (Nasdaq: CRTX) and Dey, L.P. (DEY), today began the nationwide launch of ZYFLO CR[TM] (zileuton zileuton /zi·leu·ton/ (zi-loo´ton) an inhibitor of leukotriene formation, used as an antiasthmatic. Zileuton (Zyflo) ) extended-release tablets, a twice-daily medication for the prevention and chronic treatment of asthma in patients 12 years of age and older. With a combined 240-person U.S. sales force, Critical Therapeutics and DEY have begun promoting ZYFLO CR to a targeted group of approximately 18,000 allergists, pulmonologists and primary care physicians throughout the United States. "We are excited that we are now able to offer doctors and their patients a twice-daily dosing regimen with a similar safety profile as ZYFLO[R] (zileuton tablets), our four-times-daily immediate-release formulation," said Frank Thomas, president and chief executive officer of Critical Therapeutics. "While asthma prevalence continues to rise, we are pleased that we can offer an asthma treatment with a unique mechanism of action. ZYFLO and ZYFLO CR are the only leukotriene leukotriene /leu·ko·tri·ene/ (-tri´en) any of a group of biologically active compounds derived from arachidonic acid that function as regulators of allergic and inflammatory reactions. synthesis inhibitors approved by the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). ZYFLO has already helped many patients better control their asthma symptoms and we look forward to seeing those positive outcomes continue as we bring ZYFLO CR to market." The 2007 Guidelines for the Diagnosis and Management of Asthma, which were developed by the National Asthma Education and Prevention Program (NAEPP NAEPP National Asthma Education and Prevention Program ), recommend zileuton as a therapeutic alternative for patients as part of a step-approach to reducing asthma symptoms and preventing exacerbations. It is the first time zileuton has been separately recognized in the guidelines since the NAEPP was initiated in 1989. "The potential benefit of zileuton to help control a patient's asthma is supported by its inclusion in the new NAEPP guidelines," Thomas said. "We expect the guidelines to help raise the profile of ZYFLO CR as a treatment option for the many patients whose symptoms are still uncontrolled, despite the current therapies they are taking." "Asthma impacts millions of patients in a debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction cycle of sleep disruption, interference with physical activity, absenteeism from work and school and frequent trips to the doctor's office," said Allan T. Luskin, M.D., associate professor of medicine at the University of Wisconsin. "As a novel leukotriene synthesis inhibitor, ZYFLO CR has the potential to help asthma patients improve their disease." ZYFLO CR and ZYFLO are the only FDA-approved leukotriene synthesis inhibitors for the prophylaxis prophylaxis (prō'fĭlăk`sĭs), measures designed to prevent the occurrence of disease or its dissemination. Some examples of prophylaxis are immunization against serious diseases such as smallpox or diphtheria; quarantine to confine and chronic treatment of asthma in adults and children 12 years of age and older. ZYFLO CR and ZYFLO are not indicated for use in the reversal of bronchospasm bronchospasm /bron·cho·spasm/ (brong´ko-spazm) bronchial spasm; spasmodic contraction of the smooth muscle of the bronchi, as in asthma. bron·cho·spasm n. in acute asthma attacks, but can be continued during acute exacerbations of asthma. Leukotrienes Leukotrienes A class of small molecules produced by cells in response to allergen exposure; they contribute to allergy and asthma symptoms. Mentioned in: Leukotriene Inhibitors leukotrienes are inflammatory mediators in asthma that can trigger asthma symptoms, including inflammation, swelling, bronchoconstriction and mucus secretion. ZYFLO CR uses SkyePharma PLC's (LSE LSE - Language Sensitive Editor : SKP SKP Suomen Kommunistinen Puolue (Communist Party of Finland) SKP Sveriges Kommunistiska Parti (Communist Party of Sweden) SKP Sisemajanduse Koguproduktist (Estonian) ) proprietary Geomatrix([R]) drug delivery technology, which controls the amount and rate of drug released into the body. Pricing Information ZYFLO CR will be priced at a wholesale acquisition cost (WAC WAC (Women's Army Corps), U.S. army organization created (1942) during World War II to enlist women as auxiliaries for noncombatant duty in the U.S. army. Before 1943 it was known as the Women's Auxiliary Army Corps (WAAC). Its first director was Oveta Culp Hobby. ) of $244.00 per month. The drug will be supplied to pharmacies in bottles of 120 tablets, representing a one-month supply for an individual patient. About Asthma Asthma is a chronic inflammatory disorder affecting approximately 20 million Americans. Asthma occurs when the walls of the bronchial tubes Bronchial tubes The major airways to the lungs and their main branches. Mentioned in: Common Cold become inflamed, causing the muscles to constrict con·strict v. To make smaller or narrower, especially by binding or squeezing. and extra mucus to be produced. This can lead to a broad range of symptoms from minor wheezing Wheezing Definition Wheezing is a high-pitched whistling sound associated with labored breathing. Description Wheezing occurs when a child or adult tries to breathe deeply through air passages that are narrowed or filled with mucus as a to severe difficulty in breathing. In some cases, breathing becomes so difficult during a flare-up or "asthma attack" that symptoms can be life threatening if not properly managed. About ZYFLO CR and ZYFLO ZYFLO CR and ZYFLO are the only FDA-approved leukotriene synthesis inhibitors for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. ZYFLO CR and ZYFLO are not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with ZYFLO CR and ZYFLO can be continued during acute exacerbations of asthma. The recommended dose of ZYFLO CR is two 600 mg extended-release tablets twice daily, within one hour after morning and evening meals, for a total daily dose of 2400 mg. The recommended dose of ZYFLO is one 600 mg immediate-release tablet four times a day for a total daily dose of 2400 mg. ZYFLO CR and ZYFLO are contraindicated in patients with active liver disease Liver Disease Definition Liver disease is a general term for any damage that reduces the functioning of the liver. Description The liver is a large, solid organ located in the upper right-hand side of the abdomen. or transaminase transaminase /trans·am·i·nase/ (-am´i-nas) aminotransferase. trans·am·i·nase n. See aminotransferase. elevations greater than or equal to three times the upper limit of normal. A small percentage of patients treated with ZYFLO CR (2.5%) and ZYFLO (1.9%) in placebo-controlled trials showed an increased release of a liver enzyme known as ALT and bilirubin Bilirubin The predominant orange pigment of bile. It is the major metabolic breakdown product of heme, the prosthetic group of hemoglobin in red blood cells, and other chromoproteins such as myoglobin, cytochrome, and catalase. (an orange or yellowish pigment in bile). As a result, the level of liver enzymes in patients treated with ZYFLO CR and ZYFLO should be measured by a simple blood test. It is recommended that physicians perform this test before administering ZYFLO CR and ZYFLO and repeat the test on a regular basis while patients are on the medication. Patients taking ZYFLO CR and theophylline theophylline /the·oph·yl·line/ (the-of´i-lin) a xanthine derivative found in tea leaves and prepared synthetically; its salts and derivatives act as smooth muscle relaxants, central nervous system and cardiac muscle stimulants, and should reduce the theophylline dose by 50%. Patients taking ZYFLO CR and propranolol propranolol /pro·pran·o·lol/ (-pran´o-lol) a ß, used as the hydrochloride salt in the treatment and prophylaxis of certain cardiac disorders, the treatment of tremors and of inoperable pheochromocytoma, and the prophylaxis of migraine. or warfarin warfarin (wôr`fərĭn), anticoagulant used to treat blood clots. In large doses it causes bleeding. Warfarin, mixed with bait, is used in rodent control. warfarin Anticoagulant drug, marketed as Coumadin. should be monitored and doses adjusted as appropriate. Most common side effects Side effects Effects of a proposed project on other parts of the firm. associated with the use of ZYFLO CR and ZYFLO are sinusitis sinusitis Inflammation of the sinuses. Acute sinusitis, usually due to infections such as the common cold, causes localized pain and tenderness, nasal obstruction and discharge, and malaise. , nausea and pharyngolaryngeal pain and abdominal pain, upset stomach and nausea, respectively. For full prescribing information for ZYFLO CR, please visit www.zyflocr.com or call the Company's toll free telephone number 1-866-835-8216 to request medical information. For full prescribing information for ZYFLO, please visit www.zyflo.com or call the Company's toll free telephone number 1-866-835-8216 to request medical information. About Critical Therapeutics Critical Therapeutics, Inc. is developing and commercializing innovative products for respiratory, inflammatory and critical care diseases. The Company owns worldwide rights to two FDA-approved drugs for the prevention and chronic treatment of asthma in patients 12 years of age and older: twice-daily ZYFLO CR[TM] (zileuton) extended-release tablets and ZYFLO[R] (zileuton tablets). Critical Therapeutics is working to develop products for acute asthma attacks that lead patients to the emergency room and other urgent care settings. The Company also is developing therapies directed toward the body's inflammatory response. Critical Therapeutics is located in Lexington, Mass. For more information, please visit www.crtx.com. Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for Critical Therapeutics, Inc., including, without limitation, statements regarding our commercial launch of ZYFLO CR, possible therapeutic benefits, market acceptance and future sales of ZYFLO CR and ZYFLO, the anticipated success of our co-promotion arrangements with DEY, our strategy, future operations, financial position, future revenues and projected costs, prospects, plans and objectives of management, and all other statements that are not purely historical in nature, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Without limiting the foregoing, the words "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "project," "should," "will," "would" and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks and uncertainties relating to: our ability to successfully market and sell ZYFLO CR and ZYFLO, including the success of our co-promotion arrangement with DEY; our ability to develop and maintain the necessary sales, marketing, distribution and manufacturing capabilities to commercialize ZYFLO CR and ZYFLO; patient, physician and third-party payor acceptance of ZYFLO CR and ZYFLO as safe and effective therapeutic products; adverse side effects experienced by patients taking ZYFLO CR or ZYFLO; our heavy dependence on the commercial success of ZYFLO CR; our ability to maintain regulatory approvals to market and sell ZYFLO CR and ZYFLO; our ability to successfully enter into additional strategic co-promotion, collaboration or licensing transactions on favorable terms, if at all; conducting clinical trials, including difficulties or delays in the completion of patient enrollment, data collection or data analysis; the results of preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. and clinical trials with respect to our products under development and whether such results will be indicative of results obtained in later clinical trials; our ability to obtain the substantial additional funding required to conduct our research, development and commercialization activities; our dependence on our strategic collaboration with MedImmune, Inc.; and our ability to obtain, maintain and enforce patent and other intellectual property protection for ZYFLO CR and ZYFLO, our discoveries and our drug candidates. These and other risks are described in greater detail in the "Risk Factors" section of our most recent Quarterly Report on Form 10-Q Form 10-Q See 10-Q. and other filings that we make with the Securities and Exchange Commission. If one or more of these factors materialize, or if any underlying assumptions prove incorrect, our actual results, performance or achievements may vary materially from any future results, performance or achievements expressed or implied by these forward-looking statements. In addition, the statements in this press release reflect our expectations and beliefs as of the date of this release. We anticipate that subsequent events and developments will cause our expectations and beliefs to change. However, while we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release. ZYFLO([R]) is a registered trademark of Critical Therapeutics, Inc. ZYFLO CR(TM) is a trademark of Critical Therapeutics, Inc. GEOMATRIX[R] is a registered trademark of SkyePharma PLC. |
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