Laminil© is a new anti-inflammatory treatment that stops laminitis and is available now by prescription only from a Veterinarian. Laminil is a comprehensive treatment with three components:
Laminil© is protected by U.S. Patent 9132116 and EU Patent 09844195.9 (pending).
Laminitis is an inflammatory response to stress. Laminil halts the inflammatory process. It’s simple and complex.
Like many diseases and conditions, laminitis occurs when an immune system response to stress goes wrong and starts a cascade of biochemical processes that cause inflammation and destruction of the foot. Mast cells play a key role in that cascade by releasing histamine and other inflammatory mediators, such as neutrophils, lymphocytes, and macrophages. These inflammatory agents, in turn, activate pro-inflammatory cytokines (cell-signaling proteins) that incite inflammation. Cytokines also inhibit growth factor receptors and the expression of genes involved in hoof growth and maturity. Thus, the inflammatory response both destroys cells and stops cell replacement.
Laminil is a mast cell inhibitor that intercepts the laminitis cascade at the mast cells and inhibits the release of histamine and other inflammatory mediators. By interrupting the inflammatory process at the mast cells, Laminil prevents continued release of inflammatory mediators and enables growth to resume.
Other equine products treat inflammation after it has occurred, which is good. Laminil halts the biochemical processes that result in inflammation. As inflammation subsides, growth processes can resume, and the horse can begin to heal itself. With the help of proper podiatry and continuing care, the horse will recover.
However, Laminil cannot be effective unless the stressor that initiated the laminitis episode has been positively identified and completely removed from the horse’s environment where possible.
Identifying the stressor can be difficult because the clinical signs of laminitis do not appear until 72-96 hours after initial exposure to the stressor. To identify the stressor entails thinking back to what changes occurred in the horse’s life three or four days before the clinical signs appeared.
A laminitis stressor can be a biological agent, environmental condition, or other external stimulus that causes stress to the animal. The animal responds to the stressor as a threat, which elicits the flight-or-fight immune system response that starts the laminitis cascade.
Laminitis stressors include grain overload, grass founder, equine metabolic syndrome, insulin resistance, colic, Cushings, Potomac Fever, retained placenta, steroids, vaccinations, concussion from work on hard ground, a long trailer ride, and accident.
In cases of grain, grass, and other environmental conditions, the stressor must be removed completely and immediately. The immune response and laminitis cascade will continue as long as the animal is exposed to the stressor, regardless of the quantity of exposure. Reducing the amount of the stressor will not stop the cascade.
In cases of hay laminitis where there has been no change in diet, the animal may have received too much forage and might be diagnosed as Equine Metabolic Syndrome or EMS, which is associated with obesity. Just reducing the amount of the same hay will not stop the laminitis process. The current hay has to be stopped immediately and completely. A different hay can be given in reduced amount.
The Obel Grading System is used to diagnose and assess the progression of laminitis in horses and to measure the effectiveness of treatment.
Grade 0: No lameness observed at a walk or trot, even on hard surfaces.
Grade 1: The horse may alternately lift its feet, but no lameness is observable at a walk. The horse may have a short, stilted gait when trotting in a straight line on a hard surface, and turns carefully at a walk.
Grade 2: Moves with a stiff gait at the walk. The horse may have a short, stilted gait at a trot on a hard surface. Turns with great difficulty. A foot can be lifted off the ground without great difficulty.
Grade 3: Reluctant to move at a walk on any surface. It is difficult to lift a limb. The horse may be almost non-weight bearing on one limb.
Grade 4: The animal will not move, and is particularly reluctant to move from a soft to a hard surface. It is almost impossible to lift a limb.
Laminil Perfusion was tested in clinics and in the field. In clinical studies, horses were induced to simulate grain overload laminitis. Forty-eight hours after induction, the horses displayed an average Obel Grade 3. Some horses were treated with Laminil Perfusion, and others received a placebo perfusion. All were evaluated before and 5 days after treatment.
|Before Treatment||Five Days after Treatment|
While the placebo group showed some improvement, all of the horses treated with Laminil improved dramatically—75% fully recovered to Grade 0.
The clinical results provided proof of concept for Laminil.
Halting the inflammatory response at the mast cell can stop laminitis, at least in the clinical setting with artificially induced grain overload. The real test would be in the field.
Field studies involved over a hundred horses located in clinics and barns around the country. Horses of many breeds, ages, background and conditions were involved. All had acute or chronic laminitis at median Grade 3 on the Obel Scale. The initiating stressors ran the gamut: carbohydrate overload, insulin resistance, Potomac fever, road founder, weight bearing, prolonged high fever, heat stress, retained placenta, colic, endotoxins, Cushing disease, steroids, toxic weed, and pasture founder.
All horses received Laminil Perfusion by the attending Veterinarian; there are no controls in field studies for ethical reasons. When treated and 14 days later, the horses were evaluated based on the Obel Scale, heat in feet, digital pulse, hoof tester sensitivity, and discomfort level. The results are summarized below:
Most of the owners and trainers were convinced that Laminil had helped their horses. Many felt that Laminil had saved their horses’ careers. Some felt that Laminil had saved their horses’ lives. (And that’s why we’re making Laminil available now.)
The field study showed that Laminil can help horses with acute and chronic laminitis regardless of the initiating stressor, current Obel grade, duration of current episode, or other factors. Horses that have displayed acute or chronic laminitis for weeks or months before treatment may improve more slowly and take weeks or months to recover. In every case, recovery depends greatly on continuing care, such as standing wraps, pain relief, and appropriate podiatry that stabilizes the hoof capsule and supports the sole.
The active pharmaceutical ingredient in Laminil is Cromolyn (sodium cromoglycate) which is approved by the FDA for human drugs, such as NasalCrom (NDA 20-463). Cromolyn is used to treat allergies and asthma by inhibiting the release of histamine and other agents that cause allergic reactions. Most allergy drugs are anti-histamines that combat histamine after it has been released. Cromolyn stops the allergenic response and prevents the release of histamine before it can cause allergic reactions and asthma in humans. The mode of action of Cromolyn is similar in humans and horses. Cromolyn halts the inflammatory response that characterizes laminitis.
The active pharmaceutical ingredient in Laminil, Cromolyn, has been extensively tested and widely used in humans. In FDA toxicity studies, Cromolyn was given at 388 times the recommended dose without adverse effects. According to Dr. Shirley Murphy, a leading expert, “Cromolyn sodium is virtually nontoxic because it is not metabolized in the body and is excreted unchanged in the urine and bile. This explains the almost complete absence of toxic or unwanted side-effects.” In the Laminil Perfusion, systemic exposure is limited by the tourniquet. Laminil Transdermal is applied topically around the coronary band and bulb only. Laminil has been given to over 200 horses with no toxic effects.
Shirley Murphy, M.D., Cromolyn Sodium: Basic Mechanisms and Clinical Usage.
Laminil Perfusion can help a horse with acute or chronic laminitis if, and only if, the stressor that initiated the laminitis has been identified and removed from the horse where possible.
Early diagnosis and treatment can hasten recovery. In most cases, obvious signs of improvement appear 3 days after Laminil Perfusion. With continuing care and appropriate podiatry, improvement on the Obel scale should be apparent 7 days after treatment. Failure to improve after 14 days would warrant re-examination and possibly another Laminil Perfusion.
Laminil Transdermal should be applied daily around the coronary band, heel and bulb as part of continuing care after a Perfusion. Laminil Transdermal also can be used as a prophylactic for horses prone to laminitis. However, Laminil Transdermal alone is not recommended for acute or chronic laminitis, which warrants the immediacy of a Laminil Perfusion unless that is not available for some reason.
Many farriers say that laminitis should be the first suspect when a horse has sore and ouchy feet with heat, pulse, and sensitivity. Until now, there has been no treatment for these early signs of laminitis. Laminil Transdermal promises to fill this painful gap in the arsenal of hoof care treatments.
Laminil Transdermal can stop the chronic inflammation that retards growth. Daily application around the coronary band, heel and bulb should show results in 20-30 days (one jar). Laminil Transdermal can help horses with thin-walled, thin-soled hooves, grow strong and healthy feet.
Laminil Perfusion is for veterinary use only and is administered by limb perfusion via injection into the cephalic vein at or above the knee with a tourniquet applied above the injection site. Laminil should be administered to one leg at a time. Apply the tourniquet just above the chestnut and insert the catheter just below the chestnut. Slowly infuse the entire contents of the 70ml vial. Leave tourniquet in place for 30 minutes. Remove tourniquet before removing catheter.
Withhold vasoconstrictors (cryotherapy or ice), anti-inflammatories (phenylbutazone or bute), and other vasodilators for 6 hours before and 6 hours after treatment.
MATERIALS CHECKLIST for two feet
After Laminil perfusion, apply a “standing wrap” or “track bandage”—not a polo wrap—to all four legs to support the suspensory apparatus and fetlock. Refresh and rewrap legs daily until horse can stand comfortably.
Begin daily application of Laminil Transdermal cream to the coronary band, heel, and bulb of the feet.
Apply podiatry to stabilize the hoof capsule and support the sole, which is critically important to the comfort and recovery of the horse with laminitis. Laminil Equimold Podiatry System offers a flexible mold that is easily fitted to the hoof, injected with polymer glue, and removed to leave a custom-made polymer shoe that provides proper support for the laminitic horse. Current radiographs are useful to ensure proper support is provided.
Wait 72 hours before expecting results from the Laminil perfusion, depending on timing. Early diagnosis and treatment improve results. After Laminil stops the inflammatory response, it takes time for the horse to heal, and appropriate shoeing is necessary to support the foot. In most cases, the horse shows signs of improvement 3 days after perfusion. After 7 days with prescribed after-care, the horse’s improvement should be apparent on the Obel Scale. If there’s no improvement after 14 days, re-examination by the attending Veterinarian may be necessary, and another Laminil Perfusion may be appropriate.
Apply Laminil Transdermal Cream to the coronary band and across the cleft of the bulb, daily for 30 days. One 120ml jar should be adequate for two feet for 30 days.
Prepare the area by shaving the hairline 1/4 inch above the coronary band. Daily, clean area with dry cloth and apply and rub in cream using (included) applicator. For added effect, massage cream into coronary band with gloved hands.
Laminil is available now by Veterinary prescription only as an off-label use of a drug (Cromolyn) that has been approved by the FDA for human use (NDA 20-463). Under the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA), drugs approved by the FDA for human use are available for animal use by prescription from a Veterinarian with a client/patient relationship.
Laminil Perfusion is compounded by our pharmacy partners on demand. Because Laminil Perfusion has a short shelf-life, vials are prepared when ordered and shipped overnight so Veterinarians can perform the Laminil Perfusion as soon as they receive it.
Laminil Transdermal also is made by our pharmacy partners. Each Transdermal jar contains 120ml of cream intended to treat two feet for 30 days.
Veterinarians can register, prescribe, and order Laminil Perfusion and Transdermal for clients and their horses by going to the page For Veterinarians.
The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) permits veterinarians to prescribe extralabel uses of certain approved new animal drugs and approved human drugs for animals under certain conditions. Extralabel use refers to the use of an approved drug in a manner that is not in accordance with the approved label directions. Under AMDUCA and its implementing regulations published at Title 21, Code of Federal Regulations, Part 530 (21 CFR 530), any extralabel use of an approved new animal or human drug must be by or on the lawful order of a veterinarian within the context of a veterinarian-client-patient relationship (VCPR). Extralabel use must also comply with other provisions of 21 CFR 530. A list of drugs specifically prohibited from extralabel use appears in 21 CFR 530.41.
Extralabel Use of FDA Approved Drugs in Animals
“Extralabel use” is defined as:
“Actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling. This includes, but is not limited to, use in species not listed in the labeling, use for indications (disease and other conditions) not listed in the labeling, use at dosage levels, frequencies, or routes of administration other than those stated in the labeling, and deviation from labeled withdrawal time based on these different uses.” (21 CFR 530.3(a))
Under the provisions of 21 CFR 530, the FDA recognizes the professional judgment of veterinarians, and permits the extralabel use of drugs by veterinarians under certain conditions. Extralabel use of drugs may only take place within the scope of a valid VCPR. In the absence of a valid VCPR, if an approved new animal drug is used for a use for which it is not labeled, such use has caused the drug to be deemed unsafe under the Federal Food, Drug and Cosmetic Act (“the Act”) (21 U.S.C. 360b), and therefore adulterated under the Act (21 U.S.C. 351(a)(5)).
An approved animal drug or approved human drug intended to be used for an extralabel use in an animal, other than a use in or on animal feed, is not unsafe under the Act (21 U.S.C. 360b) and is exempt from the labeling requirements under the Act (21 U.S.C. 502(f)), if such use is by or on the lawful written or oral order of a licensed veterinarian within the context of a valid VCPR and such use complies with the extralabel use regulation (21 CFR 530). Extralabel use is limited to circumstances when the health of an animal is threatened, or suffering or death may result from failure to treat. This means that extralabel use to enhance production is not permitted.
Limitations to Extralabel Use Provisions of AMDUCA
In addition to uses which do not comply with the conditions for permitted extralabel use set forth in 21 CFR 530, the following specific extralabel uses included in 21 CFR 530.11 are not permitted and result in the drug being deemed unsafe within the meaning of section 512 of the Act (21 U.S.C. 360b):
Extralabel Use in Food-Producing Animals
There are additional specific conditions that must be met for extralabel use of approved animal and approved human drugs in food-producing animals. The following conditions appear in 21 CFR 530.20:
The following additional conditions must be met for a permitted extralabel use, in food producing animals, of an approved human drug, or of an animal drug approved only for use in animals not intended for human consumption:
Extralabel use of an approved human drug in a food producing animal is not permitted if an animal drug approved for use in food producing animals can be used in an extralabel manner for the particular use.
Labeling of Drugs Prescribed for Extralabel Use
Any drug prescribed and dispensed for extralabel use by a veterinarian or dispensed by a pharmacist on the order of a veterinarian must bear or be accompanied by labeling information adequate to assure the safe and proper use of the drug. (21 CFR 530.12) At a minimum, such information shall include the following:
Prohibitions Under AMDUCA
Under the AMDUCA provisions, FDA has the right to prohibit extralabel uses of certain drugs in animals.
FDA may prohibit the extralabel use of an approved animal drug or approved human drug or class of drugs in food-producing animals if FDA determines that:
A prohibition may be a general ban on the extralabel use of the drug or class of drugs or may be limited to a specific species, indication, dosage form, route of administration, or combination of factors. 21 CFR 530.21
FDA may prohibit the extra-label use of an animal or human drug in nonfood-producing animals if FDA determines that such extra-label use presents a risk to the public health. 21 CFR 530.30
A list of drugs, families of drugs, and substances prohibited for extra-label use in animals appears in 21 CFR 530.41.
The active pharmaceutical ingredient in Laminil, Sodium Cromoglycate or Cromolyn, was discovered in 1965 by Dr. Roger Altounyan. The Armenian-American physician and pharmacologist was, himself, a lifelong asthma sufferer. Altounyan was investigating certain plants and herbs which have bronchodilation properties, when he found khella (Ammi visnaga), which had been used as a muscle relaxant since ancient times in Egypt. He inhaled derivatives of the active ingredient khellin to determine if it could block his asthma attacks. These tests resulted in his discovery of a novel class of compounds that have since entered clinical practice, and are used exclusively in Laminil equine products.
Twenty-eight years ago, Charles Owen, a farrier by training known to most as Charlie, began his amazing journey to unlock the mystery of laminitis. Starting with an idea of how laminitis originated, Charlie spent the next 17 years conducting a methodical research program to refine and validate his theory of the laminitis cascade, the chain of biochemical events that leads to laminitis. A self-educated scientist, Charlie, turned to Colorado State University to test his basic theory that the laminitis cascade can be stopped at the mast cell.
With his basic theory confirmed, the task was to find a drug that would interrupt and halt the laminitis cascade by inhibiting mast cell. Charlie contacted a major hospital that specialized in immune system treatments, and they pointed to some compounds that might succeed. He tested the compounds in the CSU laboratory and found that cromone molecules—cromolyn and nedocromil—appeared promising. He filed patents on the use of these drugs to treat laminitis under the copyrighted name Laminil©.
Next, Charlie arranged proof of concept studies on horses that had been artificially induced with laminitis. He devised the limb perfusion to deliver the drug to the affected area and converged on the appropriate dose through successive trials. In clinical studies, horses treated with Laminil recovered significantly faster than horses treated with a placebo.
With proof of concept confirmed, Charlie took Laminil to the field to test it on horses with naturally occurring laminitis. Over a hundred horses were involved in the field study. The results showed that Laminil can stop laminitis.
Charlie’s theory of laminitis was confirmed. His concept of intercepting the laminitis cascade at the mast cell was validated. His discovery of cromone molecules as effective mast cell inhibiters was clearly established. Decades of devotion and persistence came to fruition in Laminil and the new hope for horses with laminitis.
Every minute of every day,
thousands of horses around the world
endure the pain and suffering of laminitis.
It takes the lives of tens of thousands of horses every year.
It is the second leading medical cause of death.
Yet, there has been no treatment for laminitis, until now.
Laminil stops laminitis. It doesn’t cure the disease.
Laminil halts the inflammatory response
and enables the horse to heal and recover.
Our mission is to stop the pain and suffering
and the tragic loss of life
by making Laminil available to the horses that need it
Willowcroft Pharm Incorporated is a privately-held corporation dedicated to the health and happiness of hooves. We are focused on relieving horses of the pain and suffering of laminitis and helping their hooves to grow.
Our founders, Charles Owen and Robert Stevenson, are farriers. Our webmaster cares for laminitic horses. Our CEO, John Kelly, is an amateur eventer. We know that Laminil stops laminitis and promotes hoof growth. We’ve seen it work in our own horses and hundreds of others.
14260 W Newberry Rd #363
Newberry, FL 32669
Chief Technology Officer
Willowcroft Pharm, Inc., is a privately held pharma company developing products to save the lives of horses and other animals.
Willowcroft Pharm Inc.
14260 W Newberry Rd #363
Newberry, FL 32669