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Antibiotic: Infections
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Perhaps the earliest practical example is penicillin, the first marketed modern antibiotic. Fleming famously discovered penicillin in 1928, produced by the Penicillium chrysogenum mold (formerly identified as P. notatum but later found to be identical to P. chrysogenum). A decade later, Florey, Chain, Heatley, and Abraham (Oxford) began studies on Fleming's “mould juice.” They demonstrated the therapeutic potential in a mouse infection study in 1940, in one of medicine's greatest experiments. Human studies began in 1941. Production efforts grew to the point where adequate supplies became available by D-Day (1944). At war's end, penicillin became widely available and won widespread acceptance.
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When Staph methicillin resistance was found, a new antibiotic called vancomycin was developed. But since 1996, some strains of Staph have ... become resistant to vancomycin. These strains are known as VRSA. In response, the first new class of antibiotic in 35 years, linezolid, was developed in 2000, but lost its firepower against MRSA/VRSA within a year. These infections are more difficult to treat, requiring high doses of newer antibiotics. Some patients do not recover.
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Studies addressing the antibiotic treatment decision: Most studies addressed prescribing for acute respiratory infections (ARIs). Interventions were effective at reducing prescribing, with a median absolute effect of -8.9% [interquartile range (IQR) -12.4% to -6.7%]. No individual QI strategy (or combination of strategies) was more effective at reducing prescribing. Within clinician education, active educational strategies appeared more effective than passive strategies. When extrapolated to a population level, strategies targeting general antibiotic prescribing appeared to reduce antibiotic prescribing more than strategies targeting prescribing for a single condition. Few studies addressed secondary endpoints; patient satisfaction was not worsened by QI interventions, but effects on AMR or costs could not be assessed.
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New evidence that drugs used in poultry can cause antibiotic-resistant infections in consumers spurred the Food and Drug Administration's Center for Veterinary Medicine (CVM) to take action. On October 31, CVM proposed to withdraw the approval of an antibacterial, Baytril (enrofloxacin), used to treat disease in chickens and turkeys. CVM approved Baytril in 1996. Made by the Bayer Corporation of Shawnee Mission, Kan., Baytril belongs to a class of antibacterials called fluoroquinolones, which have been used in humans since 1986.
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Arpida's leading product candidate is intravenous iclaprim, a potent late-stage antibiotic that targets severe infections requiring hospital treatment, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). The US Food and Drug Administration has granted fast track status to intravenous iclaprim. In March 2007, Arpida completed patient enrolment in the second pivotal Phase III trial in complicated skin and skin structure infections. The top-line data of the second trial were reported in July 2007. The NDA-filing process is ongoing and expected to be completed by the end of February 2008.
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Cephalexin is the third most prescribed outpatient antibiotic in the United States, with over 24 million prescriptions written and sales of $140 million in 2003. Keflex is the most-recognized brand of cephalexin in the United States with more than 15 million prescriptions written each year. Although the majority of these prescriptions are substituted with generic cephalexin, Lilly's Keflex net sales in 2003 were approximately $4 million. First introduced in the 1970s, Keflex is most commonly prescribed for skin and skin structure infections.
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