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FDA approves Nuflor® premix for swine

The U.S. Food and Drug Administration recently licensed Nuflor® (florfenicol), an antibiotic for the control of swine respiratory disease (SRD).

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.

High success rate
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.

Works quickly
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 µg/ml) for 18 to 20 hours for each of the 5 treatment days.

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 Nuflor® (florfenicol) 2.3% Concentrate Solution, a water-soluble formulation for use in pigs' drinking water.

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Schering Plough

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