To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: SmithKline Beecham's Augmentin Cleared in U.S. URL: http://www.pslgroup.com/dg/623A.htm Doctor's Guide February 12, 1996
PHILADELPHIA, Feb. 12, 1996 -- SmithKline Beecham (NYSE: SBH, SBE)(SB) announced today that it has received U.S. marketing clearance for a new, more convenient adult dosing regimen of Augmentin (amoxicillin/clavulanate potassium), one of the most frequently used antibiotics for infections involving drug-resistant bacteria. In the new regimen, Augmentin is administered twice a day (BID), every 12 hours, in contrast to the three-times-a-day (TID), every-8-hour regimen used since the introduction of Augmentin in the U.S. 11 years ago. In addition to affording more convenience, the new regimen has been shown in studies in more severe infections to reduce the incidence of troublesome diarrhea associated with the product "Efficacy, convenience, and tolerability are the hallmarks that physicians and patients look for in antibiotic therapy," said Dr. Vincent Ahonkhai, vice president, anti-infectives and biologicals, at SB. "Augmentin has long set a standard for efficacy. Now the Augmentin BID regimen adds to this record the enhanced convenience of twice-a-day dosing and greater tolerability intended to improve compliance." The BID regimen for more severe infections and infections of the respiratory tract consists of a new tablet containing 875 mg of amoxicillin and 125 mg of clavulanate. In addition, the currently marketed tablet containing 500 mg of amoxicillin and 125 mg of clavulanate can now be prescribed on a twice-a-day regimen for less severe infections that may be treated with a lower dose. The effectiveness of the BID regimen has been thoroughly demonstrated. In a trial involving patients with lower-respiratory- tract infections (pneumonia and acute exacerbations of chronic bronchitis), clinical success rates at the end of therapy for patients on the BID and TID regimens were equivalent, 93.4 percent and 94.3 percent, respectively. The bacteriologic success rate, which pertains to actual eradication of bacteria, was 96.6 percent in the BID group and 90.5 percent in the TID group. The bacteria most frequently involved in these infections were Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Staphylococcus aureus. In a trial involving patients with skin infections, the clinical success rates at end of therapy were again equivalent in the BID and TID groups, 90.2 percent and 90.4 percent, respectively. The bacteriologic success rate was 92.5 percent in the BID group and 91.7 percent in the TID group. The most prevalent bacterium was beta-lactamase-producing S. aureus. In all patients treated for more severe infections during clinical trials, there was a significant reduction in the percentage of patients experiencing severe diarrhea or withdrawing from trials because of diarrhea: BID 1 percent versus TID 2.5 percent -- a reduction of 60 percent. Augmentin combines amoxicillin, an extended-spectrum antibiotic, with clavulanate, which inhibits an important mechanism of bacterial resistance. That mechanism is the production of beta-lactamases -- enzymes that destroy many antibiotics in both the penicillin and cephalosporin classes. By binding irreversibly to beta-lactamases, clavulanate protects amoxicillin from destruction. New Drug Applications for a new pediatric Augmentin BID regimen have also been filed with the U.S. Food and Drug Administration. SmithKline Beecham (NYSE: SBE, SBH) -- one of the world's leading healthcare companies -- discovers, develops, manufactures, and markets pharmaceuticals, vaccines, over-the-counter medicines, and health- related consumer products, and provides healthcare services including clinical laboratory testing, disease management, and pharmaceutical benefit management. (Full prescribing information available upon request.) AUGMENTIN(R) FACT SHEET Description -- Augmentin (amoxicillin/clavulanate potassium) is a formulation of amoxicillin, which is a broad-spectrum penicillin, and clavulanate, which is a beta-lactamase inhibitor. -- Augmentin was developed in the 1970s in direct response to the growing clinical need for a new antibiotic to treat resistant infections in both adults and children. -- Prescribed more than 320 million times in 117 countries around the world, Augmentin is one of the world's most widely used antibiotics for infections in adults and children. -- The Augmentin BID regimen for adults, which was designed to enhance convenience and increase tolerability, recently received marketing clearance in the U.S. New Drug Applications for a pediatric Augmentin BID regimen have also been filed with the U.S. Food and Drug Administration; however, the currently approved pediatric regimen in the U.S. remains TID. Indications -- Lower-respiratory-tract infections (e.g., pneumonia and acute exacerbations of chronic bronchitis). -- Otitis media (middle-ear infection). -- Sinusitis. -- Skin and skin-structure infections. -- Urinary-tract infections. Dosage Forms And Availability -- Swallow and chewable tablets and an oral suspension are available. -- As with all pharmaceutical products, Augmentin should be prescribed only by a qualified physician and in accordance with the full prescribing information. Side Effects -- Side effects, primarily mild and self-limiting, include diarrhea and nausea. -- In all adult patients treated for more severe infections during clinical trials, there was a significant reduction in the percentage of patients experiencing severe diarrhea or withdrawing from trials because of diarrhea: BID 1 percent versus TID 2.5 percent -- a reduction of 60 percent. -- Augmentin should not be used in patients with a history of allergic reactions to any penicillin, nor in patients with a previous history of Augmentin-associated cholestatic jaundice/hepatic dysfunction. For further details, consult the full prescribing information for Augmentin. Manufacturer/Marketer SmithKline Beecham Pharmaceuticals] has the exclusive rights to market [Augmentin worldwide. SmithKline Beecham -- one of the world's leading healthcare companies -- discovers, develops, manufactures and markets pharmaceuticals, vaccines, over-the-counter medicines, and health-related consumer products, and provides healthcare services including clinical laboratory testing, disease management, and pharmaceutical benefit management. SURVEILLANCE STUDY OF BACTERIAL INFECTIONS FINDS SIGNS OF DRUG RESISTANCE ACROSS THE UNITED STATES Strains of a common disease-causing bacterium isolated from patients across the United States produce enzymes associated with resistance to antibiotics, a bacteriologic study has found.(A) The bacterium, Haemophilus influenzae, is one of the leading causes of bacterial pneumonia, bronchitis, sinusitis, meningitis, and middle- ear infection. In the study, 36 percent (702/1,950) of the isolates of H. influenzae from patients in 13 geographic areas were found in laboratory tests to produce antibiotic-destroying enzymes called beta-lactamases. The fraction of H. influenzae strains producing beta-lactamases ranged from 27 per cent in Southern California to 44 per cent in the area comprising Virginia, Maryland, Delaware, and the District of Columbia. Drug Resistance An Urgent Issue Because the resistance of bacteria to antibiotics can result in treatment failures, resistance has become an urgent clinical issue. In a recent report, a task force of the American Society for Microbiology noted that its members are "gravely concerned about the national and global increase in antibiotic resistance and the complex issues surrounding this public health threat."(B) The production of beta lactamases is one of the most important mechanisms of resistance. When produced in sufficient quantity, beta-lactamases destroy certain antibiotics in both the penicillin and the cephalosporin classes. These two classes of antibiotic share a chemical structure, called a beta-lactam ring, which is the target of beta-lactamases. In addition to H. influenzae, such other disease-causing bacteria as Branhamella (Moraxella) catarrhalis and Staphylococcus aureus also may become resistant to antibiotics by producing beta-lactamases. The Role of Augmentin Not all antibiotics are equally affected by beta-lactamases. Augmentin (amoxicillin/clavulanate potassium), which has just gained U.S regulatory clearance for use in a more convenient, twice-a-day dosing regimen, has been expressly designed to overcome this type of resistance. The compound combines amoxicillin, an extended-spectrum antibiotic, with clavulanate, which inactivates beta lactamases and thus protects amoxicillin from destruction. In the national bacteriologic study, more than 99 percent (1,939/1,950) of H. influenzae strains, including beta-lactamase- producing strains, remained susceptible to Augmentin. In each of the 13 geographic areas, susceptibility to Augmentin was at least as high as 98.5 per cent. Although bacteriologic studies by themselves do not demonstrate clinical efficacy, they serve to indicate which antibiotics retain activity against increasingly resistant bacteria. In the case of Augmentin, these studies are consistent with a proven clinical record: Success rates achieved in clinical trials of the BID dosing regimen of Augmentin exceeded 90 percent both in patients with lower respiratory tract infections(C) and in patients with skin infections(D). The bacteriologic study was conducted from October 26, 1994, to April 5, 1995. One hundred and fifty-seven clinical laboratories throughout the United States were recruited to send H. influenzae isolates to Case-Western Reserve University, the Cleveland Clinic, and the University of Iowa College of Medicine for susceptibility testing. The study was funded by SmithKline Beecham as part of its efforts to help track the spread of drug resistance. (A) Haemophilus influenzae Susceptibility Program National Study, October 26, 1994 - April 5, 1995, Surveillance Data Inc., Philadelphia. (B) Report of the ASM (American Society of Microbiology) Task Force On Antibiotic Resistance, 1995. (C) Calver, A, et al., 1995. Amoxicillin/Clavulanate (A/C) BID vs A/C TID in the Treatment of Lower Respiratory Tract Infections (LRTI). Presented at the 35th Interscience Conference On Antimicrobial Agents and Chemotherapy, San Francisco, September. (D) Sperling, M, Loveless, M, et al., 1995. BID Amoxicillin/Clavulanate (A/C) versus TID A/C in the Treatment of Uncomplicated Skin/Skin Structure Infections (SSSIs). Presented at the 35th Interscience Conference On Antimicrobial Agents and Chemotherapy, San Francisco, September. 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