FDA approves NuflorÂ® premix for swine
The U.S. Food and Drug Administration recently licensed NuflorÂ®
(florfenicol), an antibiotic for the control of swine respiratory disease
Used extensively in other countries, Nuflor Premix was introduced to the U.S.
market because the pork industry here lacked a broad-spectrum, feed-grade
antibiotic that would enable mass-medication for control of SRD, which remains a
leading cause of economic losses producers, says Dr. Robyn Fleck, Manager, swine
technical services for Schering-Plough Animal Health.
Schering-Plough Animal Health conducted six clinical field trials
with Nuflor Premix at locations in Iowa, Minnesota, Nebraska, South Dakota and
Indiana. The trials involved more 1,100 sick pigs that had naturally occurring
SRD. Investigators treated the pigs for 5 days then evaluated them 2 days after
treatment stopped. They recorded temperatures and scored pigs for depression and
dyspnea (breathing difficulty). The success rate in pigs receiving Nuflor Premix
was more than 75%, significantly better than the 51% rate in untreated controls.
Pigs receiving Nuflor premix also grew twice as fast during the treatment
and evaluation period, producing an average daily weight gain of 0.665 kg
compared to 0.3353 kg in unmedicated controls. Cumulative mortality for the
group receiving Nuflor Premix (4.4%) was less than half the mortality of the
controls (9.7%), Fleck says.
While pigs receiving Nuflor had a higher
incidence of loose stools, perianal inflammation and rectal eversion compared to
controls, the side effects were transient and did not have a significant impact
on pig health or performance, as demonstrated by better survival and weight
gain, she says. Bacteria isolated from the clinically ill animals included
Actinobacillus pleuropneumoniae, Pasteurella multocida, Streptococcus
suis and Bordetella bronchiseptica, Fleck says.
Trials also have shown that Nuflor Premix is highly palatable and
can be incorporated into pelleted feeds. Furthermore, studies show that
florfenicol is quickly absorbed, reaching therapeutic concentrations in serum
within 4 to 5 hours. In the clinical trials, florfenicol concentrations remained
above target level (1 Âµg/ml) for 18 to 20 hours for each of the 5 treatment
Nuflor Premix for Swine is the second oral formulation of
florfenicol to become available to the U.S. pork industry. Last year,
Schering-Plough Animal Health introduced NuflorÂ® (florfenicol) 2.3% Concentrate
Solution, a water-soluble formulation for use in pigs' drinking water.
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