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First Inhaled Therapy For Severely Asthmatic Horses Launched In U.S.

Boehringer Ingelheim today announced the U.S. launch of the Aservo EquiHaler (ciclesonide inhalation spray), the first FDA-approved inhalant therapy for horses with severe equine asthma.

Developed after a decade of collaboration between Boehringer Ingelheim's human pharmaceutical and animal health businesses, the Aservo EquiHaler offers the promise of relief to thousands of horses that suffer from severe equine asthma, which affects 11 to 17 percent of horses.

Horses with severe equine asthma typically have clinical signs that include difficulty breathing, coughing and nasal discharge, which can have a significant impact on a horse's performance and quality of life. Over time, severely asthmatic horses may develop changes in the lung, which makes it difficult to breathe, even at rest.

“We understand the unique and inextricable link between animals and people. By delivering value through innovation, we strive to enhance the wellbeing of both and help shape the future direction of the industry,” said Caroline Belmont, Head of US Global Innovation and US Regulatory Affairs at Boehringer Ingelheim Animal Health. “We are focused on developing breakthrough therapeutics, like the Aservo EquiHaler, for animal disease areas with unmet needs to make a true impact in the lives of horses and their owners.”

The Aservo EquiHaler marks an industry first in equine medicine, as until now, there has been no FDA-approved inhalant therapy for use in horses with severe equine asthma. Severe equine asthma is an inflammatory disease of the lower airways caused by breathing in high concentrations of organic dust particles small enough to pass with air to the lower airways. Such particles are commonly found in hay and bedding.

Boehringer Ingelheim Animal Health used the Respimat inhaler, developed by the company's human pharmaceutical business, as a basis to develop the unique Soft Mist Technology of the Aservo EquiHaler, which is designed specifically for use in horses. The Aservo EquiHaler includes an ergonomic handle and dosing lever for ease of user handling, and a nostril adapter that fits inside the nostril of the horse, allowing them to easily inhale the medicated mist into their lungs.

The active ingredient in the Aservo EquiHaler (ciclesonide inhalation spray) is ciclesonide, a glucocorticoid (steroid) that becomes activated in the lungs, which allows for the targeted delivery and activation of the medication. Studies in horses with severe asthma have demonstrated that administration of ciclesonide reversed airway obstruction associated with severe asthma, and to date, ciclesonide is the only glucocorticoid not associated with suppression of serum cortisol, a desired treatment outcome.

To learn more about Aservo EquiHaler, click here.

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How Does Wildfire Smoke Affect Horse Health?

With over 100 wildfires raging in multiple states, both humans and animals are breathing unhealthy air containing smoke and particulates. These particulates can cause burning eyes, running noses and breathing complications like bronchitis. Smoke can also exacerbate heart and lung issues like congestive heart failure and asthma or heaves.

Though the composition of smoke differs with what is being burned, the particulate matter in the smoke is of the most concern. “Particulate” is a catch-all term used to encompass the mixture of solid particles and liquid droplets in the air. Particulates from smoke are very tiny, enabling them to get to the deepest part of the airways.

Horses that breathe particulates from smoke may have reduced lung function in addition to irritated eyes and respiratory tract. Particulates can also reduce the lung's ability to remove foreign materials like bacteria and pollen.

A healthy horse's respiration rate should be between 12 and 24 breaths per minute. If the horse is breathing consistently more than 30 breaths per minute, is having difficulty breathing, has flared nostrils, is coughing deeply or has abnormal nasal discharge, a veterinarian should be called.

To protect horse health during wildfires:

Limit exercise the horse is smoke is visible
Reduce exposure to dust by feeding dust-free hay or by soaking hay before feeding
Offer fresh water close to grain or hay; water will assist in clearing inhaled particulates
Contact a vet if the horse is coughing or having trouble breathing
Give a horse ideally 4 to 6 weeks to recover from airway damage from wildfire smoke once the air had cleared

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Clenbuterol Concerns Raised At Kentucky Equine Drug Research Council Meeting

The Kentucky Equine Drug Research Council (EDRC) is considering additional restrictions on clenbuterol use in the state after hair testing reveals widespread use in horses placed on the veterinarian's list after this year's federal indictments.

Dr. Bruce Howard, equine medical director for the Kentucky Horse Racing Commission, revealed at an EDRC meeting Sept. 11 that “a near 100 percent rate” of horses based in Kentucky had shown signs of clenbuterol administration on hair testing. Further, treatment sheets submitted to the KHRC as part of veterinary reporting regulations have shown instances of veterinarians prescribing the drug to entire stables.

“The KHRC office has received concerns from numerous trainers and owners who feel that clenbuterol is being misused,” said Howard, who pointed out California, Maryland, Canada, and Florida all have or are validating rules for a longer withdrawal time than Kentucky's.

Clenbuterol is a beta-2 agonist drug most commonly prescribed as a bronchodilator for horses dealing with breathing issues. As a beta-2 agonist however, it also has the side effect of repartitioning — converting slow-twitch muscle fibers to fast-twitch muscle fibers, which has a similar result to an anabolic steroid.

Currently, Kentucky regulations state clenbuterol may not be given closer than 14 days pre-race. Howard suggested pushing the timeframe back to 21 days pre-race and requiring blood and urine tests after a reported administration before the horse could return to the entry box.

But Standardbred representatives at the meeting, which was held by video conference, raised objections. Because harness horses race so frequently, they claim the 14-day timeline already makes it difficult for veterinarians to prescribe the drug to Standardbreds. Widening the gap further will exacerbate the problem.

“People will refuse appropriate treatment of their horses because of the long withdrawal period,” said council member Dr. Andy Roberts, referring to Standardbred horsemen. “It is not abused in the Standardbred sport to speak of. We have a four-day withdrawal period in the state of Ohio and you don't see horses shipping in from Ohio and just knocking people's heads in. It's really not an issue.

“I think the discussion on this drug has long been a case of people feeling like they're getting beat by somebody else when they're using this drug and I don't think there's any scientific fact that details that. As a matter of fact, the repartitioning effect, when you take the drug away, is very quickly reversed.”

Howard pointed out his intention by suggesting a longer withdrawal time was not to remove veterinarians' ability to treat horses, only to encourage responsible use.

Dr. Naveed Chowhan, chair of the EDRC, questioned whether the committee could recommend separate regulation for the breeds to the commission. Council member Dr. Jim Morehead indicated he thought this was a dangerous precedent to set.

The matter has been tabled for now.

Also at Friday's meeting, the council heard a presentation from ReCellerate, the makers of Equiflow aerosol mist. Equiflow is a non-drug biologic which is supposed to help repair damage from severe incidents of exercise-induced pulmonary hemorrhage (EIPH) and reduce incidents of bleeding without the use of Lasix. The substance, which is administered as an inhalant, is concentrated protein serum harvested from stem cell collection from donor horses.

ReCellerate representatives sought to get permission from the EDRC and KHRC to allow veterinarians to prescribe the substance to active racehorses in controlled conditions to get a better sense of its efficacy. The product is in the process of getting approval as a drug by the Food and Drug Administration (FDA); use of any non-FDA approved substance in a competing horse is required by rule to be approved by the commission.

Council members were interested in Equiflow's initally-promising results, but some voiced concerns about the challenges of getting a biologic product approved by the FDA as a drug, since it's derived from different donor horses at different times in different collections. ReCellerate representatives assured the council that along with safety and efficacy, uniformity was part of the FDA's rubric for approval.

The council also heard an update on plans for Kentucky to participate in a multi-state study on Lasix use as the state has begun its first year of a partial raceday Lasix phaseout. Initial study plans are in the works to collect video scopes on horses running with raceday and non-raceday Lasix, as well as blood samples to look for inflammatory biomarkers that could be related to EIPH incidents. Drs. Will Farmer, equine medical director for Churchill Downs Inc. and Stuart Brown, equine safety director for Keeneland, indicated the study plans are not yet ready for submission to the EDRC as part of a funding request, as organizers are still working out what the cost would be to each participating entity. The current study design would compare scopes and samples from Maryland, Kentucky, California, Louisiana, Pennsylvania, New Jersey, and Delaware.

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Ask Your Insurer Presented By Muirfield Insurance: What To Do When Shipping Your Horse To The Veterinary Clinic

Equine insurance experts answer your questions about insuring Thoroughbreds for the breeding and auction realms.

Email us at info@paulickreport. com if you have a question for an insurer.

QUESTION: In the event that my insured horse is being transported to the clinic for a procedure, what are my responsibilities as a policyholder? Are any veterinary expenses covered under my full mortality, or all-risk mortality policy?

BRYCE BURTON: The conditions of a full mortality insurance policy require that the underwriters are notified immediately should an insured animal become ill or injured. The underwriters must also be notified prior to any surgery being performed, unless the surgery is an emergency life-saving procedure. Notifying your agent and/or underwriter is mandatory at the earliest possible time.

The most efficient way to notify the underwriter is to contact your equine insurance agent so they can pass along the necessary information.

Most full mortality policies contain a free Emergency Colic Surgery Endorsement up to a $5,000 limit per occurrence on horses 91 days of age through 18 years, with no prior history of colic issues. Beyond the Emergency Colic Surgery Endorsement, either a Major Medical Endorsement, Surgical Endorsement, or Racehorse Surgical Endorsement would have to be in place in order to qualify for coverage of veterinary expenses. Please see the previous article regarding Major Medical coverage here.

QUESTION: What do I need to do in the event that my insured horse is in a life-threatening situation?

BRYCE BURTON: In the event that an insured horse is facing a life-threatening situation, the policyholder should call their agent immediately. It's always a good idea for an insured to have the agent's after-hours number saved so that it's accessible at all times.

It's also beneficial to have the horse's name, dam's name, age, attending veterinarian's contact, and care- taker's contact on hand for the agent. The agent will then reach out to an emergency adjuster, who will take over from there. The adjuster will need to speak directly to the vet and/or caretaker of the horse regarding the situation in order to ensure that everyone is on the same page with respect to the horse's health moving forward.

Bryce Burton is a property and liability specialist for Muirfield Insurance. He is from Frankfort, Ky., where
he grew up an avid race fan. His Thoroughbred racing fandom combined with a collegiate internship in the insurance industry, culminated in a start in the equine insurance field. Bryce has been with Muirfield Insurance since 2014, following his graduation from Transylvania University in Lexington.

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