We hope you don’t need it, but if you do, Laminil is available now in the US, Canada, Australia, and Dubai.

What is Laminil?

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 IV Perfusion is an injectable solution for treating acute and chronic laminitis and is administered by limb perfusion.
  • Laminil Transdermal is a topical treatment for early symptoms of laminitis, chronic inflammation, and retarded hoof growth. Laminil cream is part of continued treatment after the perfusion.
  • Laminil Podiatry uses the Equimold© system to make a custom-fitted shoe that stabilizes the hoof capsule and supports the sole.

Laminil© is protected by U.S. Patent 9132116 and EU Patent 09844195.9 (pending).

How Does Laminil Stop Laminitis?

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.

Ingredients: What’s in Laminil?

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.

Safety: Is Laminil Safe in Treating 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.

Will Laminil Help My Horse with Laminitis?

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.

How is Laminil Administered? Perfusion Protocol

Watch a video of the Laminil Perfusion Process

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

  1. (2) 70 mL vials of Laminil (cromolyn injectable)
  2. (4) Sterile 35cc syringes (2 for each foot)
  3. Sedative to keep the horse calm and still during the perfusion
  4. Isopropyl alcohol to aseptically cleanse the injection area.
  5. (2) 22-23 gauge butterfly Surflo winged infusion sets (catheters)
  6. (2) 4×4 gauze rolls
  7. (1) Tourniquet (Esmach or Kerlix) that is at least 4-inches wide
  8. Tape to secure catheter.

PROCEDURE

  1. Fill and set aside four 35ml syringes with the contents of two 70ml vials of Laminil.
  2. Sedate the standing horse to remain calm and still during the perfusion (about an hour).
  3. Shave and aseptically prepare the injection area with isopropyl alcohol. Do not use iodine solution.
  4. Wrap leg with 4×4 rolled gauze above the chestnut and apply tourniquet over the gauze.
  5. Insert butterfly catheter into the cephalic vein below the chestnut and secure with tape.
  6. Insert syringe in catheter.
  7. Slowly infuse Laminil , taking at least 2 minutes to infuse each of two syringes.
  8. Keep both tourniquet and catheter in place for 30 minutes after infusion.
  9. Remove tourniquet before removing catheter to reduce swelling at the injection site.
  10. Complete the procedure on one leg before administration to second leg. Do not apply tourniquets to both legs at the same time.

After-care

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 resin, 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.

Applying Laminil Transdermal Cream

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.

Availability: How to Purchase Laminil

Laminil is available now by Veterinary prescription only as an extralabel 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. The retail price is $240 per vial for treatment of 1 foot.

Laminil Transdermal also is made by our pharmacy partners. Each Transdermal jar contains 120ml of cream intended to treat two feet for 30 days. The retail price is $240 per jar.

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)

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):

  1. Extralabel use in an animal of an approved new animal drug or human drug by a lay person (except when under the supervision of a licensed veterinarian);
  2. Extralabel use of an approved new animal drug or human drug in or on an animal feed;
  3. Extralabel use resulting in any residue which may present a risk to the public health; and
  4. Extralabel use resulting in any residue above an established safe level, safe concentration, or tolerance.

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:

  1. There is no approved animal drug that is labeled for such use and that contains the same active ingredient in the required dosage form and concentration, except where a veterinarian finds, within the context of a valid VCPR, that the approved animal drug is clinically ineffective for its intended use.
  2. Before prescribing or dispensing an approved animal drug or approved human drug for an extralabel use in food animals, the veterinarian must:
    • Make a careful diagnosis and evaluation of the conditions for which the drug is to be used;
    • Establish a substantially extended withdrawal period prior to marketing of milk, meat, eggs, or other edible products supported by appropriate scientific information, if applicable;
    • Institute procedures to assure that the identity of the treated animal or animals is carefully maintained; and
    • Take appropriate measures to assure that assigned time frames for withdrawal are met and no illegal drug residues occur in any food producing animal subjected to extra-label treatment.

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:

  1. Such use must be accomplished in accordance with an appropriate medical rationale; and
  2. If scientific information on the human food safety aspect of the use of the drug in food producing animals is not available, the veterinarian must take appropriate measures to assure that the animal and its food products will not enter the human food supply.

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:

  1. The name and address of the prescribing veterinarian. If the drug is dispensed by a pharmacy on the order of a veterinarian, the labeling shall include the name of the prescribing veterinarian and the name and address of the dispensing pharmacy, and may include the address of the prescribing veterinarian.
  2. The established name of the drug (active ingredient), or, if formulated from more than one active ingredient, the established name of each ingredient.
  3. Any directions for use specified by the veterinarian (including class/species or identification of the animal(s) being treated; dosage, frequency, and route of administration; and the duration of therapy).
  4. Any cautionary statements.
  5. The veterinarian’s specified withdrawal, withholding, or discard time(s) for meat, milk, eggs, or any food which might be derived from the treated animal(s).

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:

  1. An acceptable analytical method needs to be established and such method has not been established or cannot be established; or
  2. The extralabel use of the drug or class of drugs presents a risk to the public health.

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.

Herbal Origin of Laminil

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.

Who Invented Laminil?

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.

Mission Statement: Stop 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

now.

 

Who is Willowcroft Pharm?

Willowcroft Pharm Incorporated is a privately-held equine pharmaceutical company that develops innovative and effective treatments for horses. Our initial product, Laminil, is the first effective treatment for laminitis, which is the second leading cause of death in horses. Our next products will be similarly innovative and effective in treating common equine ailments.

The President, John Kelly, is an eventer with a Ph.D. who has written books and articles on topics ranging from whales to radioactive waste.  After five years as a university professor, Dr. Kelly founded a consulting firm that specialized in managing nuclear materials worldwide.  He ran the firm for 25 years, and now focuses on riding horses and competing in three-day eventing.  Over the past decade, Dr. Kelly has participated in several pharmaceutical start-ups as an advisor and investor.

In May 2016, at the request of his old fox-hunting friend, Charlie Owen, and with the enticement of saving horses, Dr. Kelly agreed to take the reins of Willowcroft Pharm and bring Laminil to market, which occurred in December 2016. Now, Dr. Kelly is building an international network of compounding pharmacies to make Laminil available worldwide and preparing Willowcroft Pharm’s next innovative treatment for market.

Willowcroft Directors include Charles Owen and Robert Stevenson, who are farriers with over 40 years of combined experience treating horses with laminitis. Charlie Owen dedicated nearly half his life to finding an effective treatment for laminitis; his story is told in the Who Invented Laminil section. Robert Stevenson is a master farrier from Queensland, Australia, an expert in equine podiatry, and the inventor of Equimold; his story is told in the Equimold section.

Many have contributed time, resources, and expertise to the development of Laminil. University faculty and staff helped Charlie go from test tubes to clinical trials and field studies in developing, testing, and confirming his theory of the laminitis cascade. Friends contributed resources and volunteered their horses in testing the product in development stages. Attorneys helped Charlie secure patents. Our webmaster, who cares for laminitic horses, has contributed countless hours to the Laminil.us website. Our compounding pharmacy partner has formulated Laminil products throughout the development process. Last and more important, hundreds of horses and their owners and veterinarians have participated in field studies, fortunately, with major benefit to the horses and no toxic effects. Now, the challenging work of marketing Laminil and the exciting work of saving horses begins.

 

Mailing address:

Willowcroft Pharm
14260 W Newberry Rd #363
Newberry, FL 32669

Email:

info@willowcroftpharm.com

Telephone:

Charles Owen,
Chief Technology Officer
(303) 875-7402