Pour-on Banamine may revolutionize pain management for cattle
March 29, 2018
Merck Animal Health introduced the first and only FDA-approved NSAID for controlling pain in a food animal this February at the National Cattlemen's Beef Association Convention. Approved for controlling pain from foot rot and fever from bovine respiratory disease, BRD, Banamine® Transdermal (flunixin transdermal solution) has the potential to revolutionize pain mitigation practices for cattle producers.
"We took an old product that has been around since the mid-'70s and we completely reinvented it," said Chance Morrow, Merck Animal Health product manager for Banamine Transdermal. "We took it from an intravenous product to a pour-on."
As the first and only product in food animal production for pain control, Merck is taking the first steps into a brand-new market in the pharmaceutical industry and pain management.
"It speaks to Merck's dedication and commitment to the beef and food animal industry," Morrow said. "It is a new product in an emerging market of the industry. It is exciting to be the first in that market."
“The revolutionary aspect of this is that there is now a product out there to address some of our biggest animal welfare issues. I believe there will be competition that comes to the table sooner rather than later, but with pain management this can only be a good thing for the industry.”Chance Morrow, Merck Animal Health product manager for Banamine Transdermal
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FDA regulations and approval processes in the United States are commonly stricter than anywhere in the world. The idea for this pour-on initially started almost 12 years ago.
"Our government requires a complete understanding of all pharmaceuticals used in food animals," said Dr. Justin Welsh, Associate Director of Ruminant Technological Services for Merck Animal Health. "Through this understanding, vets and producers can use these products to improve animal well-being while ensuring a safe food supply."
On the market in Europe and Canada for the past three years, Banamine Transdermal is expected to revolutionize animal welfare standards for the food animal industry in the U.S.
"The revolutionary aspect of this is that there is now a product out there to address some of our biggest animal welfare issues," Morrow said. "I believe there will be competition that comes to the table sooner rather than later, but with pain management this can only be a good thing for the industry."
With increasing demands for higher standards of animal welfare practices coming from consumers, Banamine Transdermal is a step in the right direction for addressing pain management and mitigation.
"It meets a need that I am not sure the industry completely understands it should be concerned about for animal well-being and increased welfare expectations from consumers," Morrow said. "This product allows the industry to set its own standards for those things when it comes to pain management."
Research and development tested various compounds to find the best formulation to deliver Banamine safely and effectively through the skin. Formulated to penetrate cow-hide, typically 9 millimeters thick, it is not labeled, and strongly discouraged, from use on any other animal species.
"When Banamine was first launched in 1978, it was used intravenously," Dr. Welsh said. "It is a big step to take it from an injectable product to something used topically."
The pour-on reaches an effective level in the body in less than an hour and, according to the label, works for at least six hours. However, Dr. Welsh stated the trials only looked into the product working for six hours, continued research could reveal the product works significantly longer. One of the biggest benefits of a pour on is the elimination of injection-site lesions.
"One of the top five residues in cattle meat is flunixin, the main active ingredient in Banamine," Dr. Welsh said. "It can be hard to give intravenous shots to cattle and it is stressful on the animal. Sometimes this leads people to giving it in the muscle. Injectable Banamine is not labeled for that and should not be given that way because it creates lesions and discounts at slaughter."
The safety benefits of pouring the product down the midline of the back is for both the producer and animals. However, it is recommended that those handling the product wear protective clothing and gloves to prevent absorption. Despite these application precautions, this product is more BQA-friendly than traditional Banamine.
"The withdrawal time for the intravenous Banamine is four days, but for the transdermal formulation it is eight," Dr. Welsh said. "When something is put directly into the bloodstream it is metabolized and eliminated from the body a lot quicker."
On label, Banamine Transdermal is marketed for controlling pain from foot rot and controlling fever, pyrexia, from BRD.
"We know that NSAIDs as a class of drug, can have positive effects controlling pain from surgical procedures as well," Dr. Welsh said. "Producers can mitigate pain from things like dehorning, castration and branding by administering pain medication before the procedure. However, there currently are not products on the market labeled for that."
With the potential for positive benefits in other areas, Merck plans to continue clinical trials for controlling pain from other common diseases and procedures in beef cattle. This is in addition to working towards a label for dairy cattle. Banamine Transdermal is a prescription NSAID and should always be accompanied by a prescription from a licensed veterinarian.
"The pour-on will be more expensive than the injectable form," Dr. Welsh said. "However, when you take into account the intrinsic factors: ease of use, other equipment used for the injectable, it becomes a good value proposition. There are other products producers can use off label that are less expensive but none that are FDA-approved for any label indication for pain reduction in food animals in an easy-to-deliver formulation."
One of the holdups for developing pain management NSAIDs was from the inability to measure pain in animals. Merck was able to develop a way to measure pain in cattle caused by foot rot, a huge step in research for food animals for increased welfare practices.
"One of the reasons there are no other approved products for pain management in the U.S. is because up until now we have not been able to objectively measure pain," Morrow said. "A pressure mat system was developed to measure pain associated with foot rot. We would walk the animals across the pressure mat and we could see where they were not putting force or pressure on their sore foot. Once treated, they were walked across the mat again and an improvement in the amount of weight put on their sore feet was observed. This was how we were able to objectively evaluate pain in an animal."
Merck has introduced three new products for beef producers in the past year, Banamine Transdermal, Revalor XH and Whisper stethoscope.
"We have several more products for beef producers coming in the next couple of months," Morrow said. "We are committed to the food animal industry. This is truly a neat product that changes the game for pain management. As a company, we are excited to see what products come to the table in this sector. We will continue to work towards expanding the label of Banamine Transdermal, both in beef and dairy cattle."