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| |  New Type Of Quinolone Antibiotic, Tequin, Approved By FDA for RTIs PRINCETON, N.J. -- January 18, 2000 -- Bristol-Myers Squibb Company has announced that Tequin(TM) (gatifloxacin), a new type of quinolone antibiotic, has been approved by the U.S. Food and Drug Administration for indications including the treatment of community-acquired respiratory tract infections (RTIs). Tequin was designed with a unique 8-methoxy structure that appears to enhance bactericidal action and decrease the rate of the development of resistance of gram-positive bacteria. Tequin is the first and only antibiotic of this type available in bioequivalent 400 mg oral and IV formulations.
"The major challenge for physicians treating common respiratory infections is finding an antibiotic that eradicates the major organisms and is safe and easy for patients to take," commented Michael S. Niederman, M.D., chief, Division of Pulmonary and Critical Care Medicine, and acting chairman, Department of Medicine, Winthrop-University Hospital, Mineola, New York. " Tequin (TM) (gatifloxacin) shows greater than 90 percent clinical cure and eradication rates of the pathogens most responsible for RTIs, particularly Streptococcus pneumoniae, which accounts for more than 40 percent of community respiratory infections in the U.S." Tequin has been shown in clinical trials to provide excellent efficacy and tolerability. Tequin is effective in the treatment of patients with acute exacerbation of chronic bronchitis, acute sinusitis and community-acquired pneumonia caused by indicated susceptible strains of gram-positive and gram-negative bacteria that include S. pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae and Legionella pneumoniae. Tequin has produced an overall clinical success rate of greater than or equal to 90 percent in acute exacerbation of chronic bronchitis, 96 percent in acute sinusitis and greater than or equal to 97 percent in community-acquired pneumonia. The incidence of RTIs, such as bronchitis, sinusitis and community-acquired pneumonia, has increased almost 50 percent in the past 10 years in the U.S. - to approximately 125 million cases per year. The rise in RTIs has driven the development of newer antibiotics, such as macrolides and fluoroquinolones. The mechanism of action of fluoroquinolones including Tequin is different from that of penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines. Therefore, fluoroquinolones may be active against pathogens that are resistant to these other antibiotics. There was no cross-resistance between Tequin (TM) (gatifloxacin) and these other drugs. In clinical trials, the in vitro activity of Tequin against important respiratory tract pathogens was greater than 99 percent. "Tequin represents the newest antibiotic to emerge from Bristol-Myers Squibb and offers physicians a new type of quinolone antibiotic to treat RTIs," commented Rick Lane, President, U.S. Medicines, Bristol-Myers Squibb. "Its development is consistent with our heritage and longstanding commitment to infectious disease, as well as our company's mission of extending and enhancing human life." Tequin is primarily excreted through the kidneys and less than one percent is metabolized by the liver. To date, Tequin has been administered worldwide to over 10,000 adult patients in clinical trials. It has been found to be a safe and well-tolerated treatment in 15 international clinical trials at 500 study sites. In a clinical study (n=48), Tequin demonstrated a lower potential for producing delayed photosensitivity skin reactions than ciprofloxacin or lomefloxacin, and was comparable to placebo in causing these same reactions. Tequin is dosed 400 mg once daily for all indications. The availability of Tequin in bioequivalent 400 mg oral and IV formulations facilitates an easy transition for patients who begin treatment in the hospital and continue on oral therapy at home. The most common side effects associated with Tequin (TM) (gatifloxacin) in clinical trials were gastrointestinal. Adverse reactions considered to be drug related and occurring in greater than or equal to three percent of patients were: nausea (8 percent), vaginitis (6 percent), diarrhea (4 percent), headache (3 percent) and dizziness (3 percent). Tequin should not be administered within four hours before or after administration of an antacid or a mineral supplement, such as iron or calcium. The safety and efficacy of Tequin in children, adolescents (under 18), pregnant women and nursing mothers have not been established. Tequin is contraindicated in persons with a history of hypersensitivity to gatifloxacin or any member of the quinolone class of antimicrobial agents. As with other quinolones, Tequin should be used with caution in patients with known or suspected central nervous system disorders or patients who have a predisposition to seizures. Tequin may have the potential to prolong the QTc interval of the electrocardiogram in some patients, and, due to limited clinical experience, Tequin should be avoided in patients with known prolongation of the QTc interval, patients with uncorrected hypokalemia and patients receiving Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic agents. Tequin should be used with caution when given together with drugs that may prolong the QTc interval (e.g., cisapride, erythromycin, antipsychotics, tricyclic antidepressants), Tequin (TM) (gatifloxacin) was licensed by Bristol-Myers Squibb from Kyorin Pharmaceutical Company Ltd. in September 1996, for development and marketing in the U.S., Canada, Brazil, Mexico, Argentina, Australia, and certain other countries.
Related Link: Bristol-Myers Squibb Company.
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