SmithKline Beecham's Bactroban Nasal Now Available; First Intranasal Product Approved for the Eradication of MRSA, a Resistant Bacteria Linked to Infection Outbreaks

Business Wire, April 29, 1996

PHILADELPHIA--(HealthWire)--April 29, 1996--SmithKline Beecham announced today that Bactroban(R) Nasal (mupirocin calcium ointment), 2%, which recently was cleared for marketing by the U.S. Food and Drug Administration (FDA), now is available nationwide. Bactroban Nasal is a new formulation of the company's topical antibiotic, Bactroban (mupirocin). Bactroban Nasal is the first intranasally administered topical agent shown to be effective in the eradication of nasal colonization with methicillin-resistant Staphylococcus aureus (MRSA) in adult patients and health care workers as part of a comprehensive infection control program to reduce the risk of MRSA infection during institutional outbreaks of infections with this pathogen. A problem first confined to tertiary care centers and large teaching hospitals, MRSA outbreaks increasingly affect hospitals and other health care institutions of all sizes and, once established, have proven extremely difficult to eradicate.

According to an estimate from the Centers for Disease Control and Prevention (CDC), each year approximately two million patients in the U.S. contract hospital-acquired infections, at an estimated cost of $4.5 billion (1992 dollars). Further complicating this costly problem is antibiotic resistance, which hampers treatment of the infections. Indeed, severe infection with MRSA has been associated with longer hospital stays and increased risk of death compared to severe infection with methicillin-sensitive Staphylococcus aureus.

"By eliminating MRSA from the nostrils of patients and health care workers, Bactroban Nasal affords physicians the potential opportunity to reduce the incidence of serious and sometimes life-threatening infections during outbreak situations. This in turn may decrease the length of hospital stays and decrease hospital costs," said Jerry Karabelas, PhD, president, North America, SmithKline Beecham.

Analysis of six U.S. clinical trials designed to evaluate the effectiveness of Bactroban Nasal in eliminating S. aureus from the nostrils in health care workers showed that of the volunteers evaluated for efficacy, nasal carriage of S. aureus was eliminated in 91 percent (130/143) of volunteers receiving Bactroban Nasal but in only 6 percent (8/142) of volunteers receiving placebo. In addition, 74 percent (96/130) of the volunteers treated with Bactroban Nasal who were free of S. aureus at the end of therapy (five days) remained free of the bacteria four weeks after treatment compared with 12.5 percent (1/8) of the placebo volunteers. No serious side effects were reported. Only one of 339 participants withdrew from the study due to a side effect. The most frequently reported side effects associated with Bactroban Nasal were headache (9%), rhinitis (6%), and respiratory disorder including upper respiratory tract congestion (5).

The carriage of MRSA in the nostrils in patients and health care workers leads to increased rates of MRSA infection within the health care environment. Patients at high risk of MRSA infection may include those undergoing surgery and those being treated in intensive care units. For this reason, it is important to contain nasal carriage of MRSA.

Bactroban Nasal is the first product in the U.S. indicated for the elimination of MRSA from the nostrils, where these bacteria commonly are found. By eradicating MRSA from the nose, Bactroban Nasal interrupts the transmission of the bacteria to a potential site of infection.

"Many health care professionals and patients do not fully understand that carrying S. aureus in the nose can lead to infection in other parts of the body," said Richard P. Wenzel, MD, MSc, Professor and Chairman, Department of Internal Medicine, Medical College of Virginia, Virginia Commonwealth University. "By eradicating methicillin-resistant S. aureus from the nose, you can stop the bacteria from being spread to other body sites (like intravenous access sites, or surgical wounds) causing infections."

Bactroban Nasal is available in a 1-gram single-use applicator tube and is formulated specifically for intranasal use. The recommended course of therapy is twice daily application for 5 days.

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. -0-

For more information, see brief summary of Prescribing Information.

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