New Antibiotic Addresses Emerging Public Health Concern
PHILADELPHIA, Sept. 26 /PRNewswire-FirstCall/ -- GlaxoSmithKline today
announced that Augmentin XR(TM) (amoxicillin/clavulanate potassium) Extended
Release Tablets has received United States Food and Drug Administration (FDA)
approval for the treatment of adults with acute bacterial sinusitis (ABS) or
community-acquired pneumonia (CAP). Specifically, Augmentin XR is indicated
for the treatment of patients with ABS or CAP confirmed or suspected to be
caused by beta-lactamase-producing bacteria such as Haemophilus influenzae,
Moraxella catarrhalis and Streptococcus pneumoniae (S. pneumoniae) with
reduced susceptibility to penicillin (i.e., penicillin MICs* = 2 mcg/mL).
S. pneumoniae with penicillin MIC >/= 2 mcg/mL are considered resistant to
penicillin.
Augmentin XR employs a unique extended release formulation -- bi-layer
tablets that provide an immediate release of amoxicillin and clavulanate
potassium and an extended release of amoxicillin. This enhanced formulation
prolongs the time that the bacterium is exposed to the antibiotic and promotes
coverage of tough-to-treat S. pneumoniae. Augmentin XR is the first
antibiotic to be approved for the treatment of both ABS and CAP caused by
strains of this bacterium with reduced penicillin susceptibility
(MIC = 2 mcg/mL).
"Years ago, most antibiotics approved for respiratory tract infections
were effective," said Michael Benninger, M.D., Chairman of the Department of
Otolaryngology -- Head and Neck Surgery at Henry Ford Hospital, Detroit, Mich.
"But recently, S. pneumoniae resistance to penicillin has increased
dramatically -- to about 20 percent nationwide - making antibiotic selection
very important. Augmentin XR will be important in physicians' efforts to
continue to successfully fight infection, given today's environment of
bacterial resistance."
Bacterial Respiratory Infections Becoming Harder to Treat
In recent years, common bacteria such as S. pneumoniae, Haemophilus
influenzae and Moraxella catarrhalis that cause respiratory tract infections
like ABS and CAP have become increasingly resistant to antibiotics.
Antibiotic resistance occurs when bacteria change in different ways that
reduce or eliminate the effectiveness of drugs, chemicals or other agents
designed to cure or prevent infections. The surviving bacteria continue to
multiply in the body, possibly causing more harm. Widespread use of
antibiotics promotes the spread of antibiotic resistance. According to the
U.S. Centers for Disease Control and Prevention, antibiotic resistance is a
serious public health problem.
"With Augmentin XR, GlaxoSmithKline has responded to a medical need for
antibiotics that continue to be effective in this era of evolving drug
resistance," said Brian Lortie, Vice President, Anti-Infectives,
GlaxoSmithKline. "We are proud to offer physicians a powerful new tool to
help them with this emerging public health problem."
About Augmentin XR
Augmentin XR is a member of the beta-lactam class of antimicrobials and is
made up of amoxicillin and clavulanate potassium. Each Augmentin XR Extended
Release Tablet contains 1000 mg of amoxicillin and 62.5 mg of clavulanate.
The clavulanate component is critical because it inactivates beta-lactamase,
an enzyme produced by certain bacteria, including Haemophilus influenzae and
Moraxella catarrhalis, that render many beta-lactam antibiotics (e.g.,
amoxicillin and penicillin) inactive. Augmentin XR Extended Release Tablets
and Augmentin ES-600(TM) (amoxicillin/clavulanate potassium) Powder for Oral
Suspension are the only high-dose amoxicillin oral antibiotics that also
inactivate beta-lactamase.
Augmentin Tablets (250 mg or 500 mg) cannot be used to provide the same
dosages as Augmentin XR Extended Release Tablets. This is because Augmentin
XR contains 62.5 mg of clavulanate, while the Augmentin(R) 250 mg and 500 mg
tablets each contain 125 mg of clavulanate. In addition, the Extended Release
Tablets provide an extended time course of plasma amoxicillin concentrations
compared to immediate release Tablets. Thus two Augmentin 500 mg tablets are
not equivalent to one Augmentin XR tablet.
Clinical Trial Results
Augmentin XR has shown strong clinical success. Adults with ABS were
evaluated in three clinical studies. In one comparative study, the rate of
clinical success in patients with ABS was 87 percent (N=123) at test of cure.
In two non-comparative, multicenter trials for ABS, clinical success with
Augmentin XR was 93 percent (N=677) and 94 percent (N=632) at test of cure.
In patients suffering from CAP, in three comparative studies (N=582), the
clinical success rates at test of cure (day 16 to day 39 following start of
therapy) ranged from 86 (N=204) to 95 percent (N=114).
Microbiologic eradication rates for key pathogens in these studies are as
follows:
-- In ABS clinical trials, Augmentin XR eradicated S. pneumoniae with
penicillin MIC = 2 mcg/mL in 93 percent (N= 14) of strains from
clinically evaluable patients. S. pneumoniae strains with penicillin
MIC >/= 2 mcg/mL are considered penicillin resistant.
-- In CAP clinical trials, Augmentin XR eradicated S. pneumoniae with
penicillin MIC = 2 mcg/mL in 100 percent (N=10) of strains from
clinically evaluable patients.
-- In combined ABS studies, Augmentin XR eradicated beta-lactamase
producing Haemophilus influenzae and Moraxella catarrhalis in
97 percent (N=30) and 98 percent (N=57) of strains from clinically
evaluable patients.
-- In addition, Augmentin XR eradicated beta-lactamase producing
Haemophilus influenzae and Moraxella catarrhalis in 94 percent
(N=16) and 87 percent (N=15) of strains from clinically evaluable
patients, respectively in combined CAP studies.
Augmentin XR was studied in over 4,100 patients and was generally well
tolerated, with only 2 percent of patients discontinuing therapy due to
drug-related side effects. The most commonly reported side effects in
clinical trials were diarrhea (15.6 percent), nausea (2.2 percent), yeast
infection (2.1 percent) and abdominal pain (1.6 percent). Augmentin XR is
contraindicated in patients with a history of allergic reaction to any
penicillin and in patients with a previous history of cholestatic
jaundice/hepatic dysfunction associated with amoxicillin/clavulanate
potassium. Augmentin XR is also contraindicated in patients with severe renal
impairment and in hemodialysis patients.
About GlaxoSmithKline
GlaxoSmithKline, one of the world's leading research-based pharmaceutical
companies, is committed to improving the quality of life by enabling people to
do more, feel better and live longer. For complete prescribing information
for Augmentin XR Extended Release Tablets, Augmentin ES-600 or Augmentin,
visit http://www.gsk.com or call 1-888-825-5249.
* MIC stands for "minimum inhibitory concentration". This is the minimum
concentration or the smallest amount of an antibiotic that is needed to
inhibit bacterial growth in a laboratory test. The lower the MIC, the
more susceptible is the bacterium to the antibiotic.
SOURCE GlaxoSmithKline
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Related links:
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CONTACT:
Karen Collins of GlaxoSmithKline,
+1-919-483-2839
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