The field study for Laverdia-CA1’s (verdinexor tablets) safety and effectiveness in dogs with lymphoma has been completed, according to Anivive, a software-driven pet health company behind the drug’s development. Laverdia-CA1, which received conditional approval from the FDA in 2021, presents a promising oral treatment option for canine lymphoma as it offers a non-invasive approach for veterinary oncology patients, according to a news release.

For the study, 150 dogs were chosen to participate in the trial from more than 700 applicants. The study was a randomized, placebo-controlled, double-masked study that was conducted throughout 12 clinical sites in the United States. Patient treatment and data collection concluded with the closure of the final study site on December 12, 2024, according to Anivive.

With data collection now finished, Anivive has locked the database to start statistical analysis. Results are anticipated in the coming months. The company plans to submit the Effectiveness technical section of the new animal drug application for regulatory review this summer. The FDA has already deemed all other major sections of the application complete, according to Anivive.

 The company will also be submitting for full approval of the drug in Brazil, Australia, the United Kingdom, and the European Union once the data package is finalized.

“This achievement represents a key milestone in Anivive's mission to deliver innovative cancer treatments to companion animals, such as this new first-in-class XP01 blocker,” wrote the company in a news release.

"The completion of our critical study for LAVERDIA-CA1 marks a major milestone in bringing forward an innovative therapy for canine lymphoma,” Dylan Balsz, CEO of Anivive, said in the release.

 "We are excited to analyze the data and move closer to making an oral treatment option available for dogs living with this challenging disease."

In 2021, Laverdia-CA1 became the first conditionally approved oral treatment for dogs with lymphoma. The drug prevents certain proteins from leaving the nucleus of cancer cells, in turn helping these proteins control the growth of cancerous cells in dogs and prevent their spread.

 It is administered orally twice a week with at least 72 hours between doses.

When handling Laverdia-CA1 and cleaning up after a treated dog, and for 3 days post-treatment, veterinarians should wear gloves tested for use with chemotherapy drugs. Cases where gloves should be worn include handling the patient’s food and water bowls, and the patient’s feces, urine, vomit or saliva.

Owners of dogs with lymphoma can also administer the drug at home with a veterinarian prescription and client information sheet.

According to the FDA, pregnant women, women who may become pregnant, nursing women, and children should not handle or administer Laverdia-CA1 nor touch the feces, urine, vomit or saliva of treated dogs.

 with dvm360, Craig A Clifford, DVM, MS, DACVIM (Oncology), offered insight on the novel drug. “We know for the average dog, it may hold the disease for about 3 months or so, so [the drug is] not meant to be a silver bullet—a cure-all for lymphoma,” he explained.

 “[Most] likely in the future, oncologists will be combining it with other agents in other types of protocols. But to me, knowing that 80% of lymphomas are left untreated, [the drug] gives the primary care a game changer—something else that they can utilize, other than just prednisone.”

According to Clifford, veterinary oncologists are beginning to see that Laverdia-CA1 also has a very high response rate against T cell lymphoma—a rare form of cancerous lymphoma that is challenging to treat with few drugs that treat it available. “We’re starting to see that there may be other avenues for this agent,” said Clifford.

“Right now, I view it more as a primary care drug, and I think that’s great because to me, we’re expanding access, meaning more cases are going to get treated, and it’s an unmet need, and I think this drug checks both of those boxes,” he concluded.

Anivive announces completion of Laverdia®-CA1 pivotal field study for canine lymphoma. News release. Anivive Lifesciences Inc. February 14, 2025. Accessed February 14, 2025. 

https://prnmedia.prnewswire.com/news-releases/anivive-announces-completion-of-laverdia-ca1-pivotal-field-study-for-canine-lymphoma-302377090.html

FDA conditionally approves first oral tablet to treat lymphoma in dogs. News release. US Food and Drug Administration. January 11, 2021. Accessed February 14, 2025. 

https://www.fda.gov/news-events/press-announcements/fda-conditionally-approves-first-oral-tablet-treat-lymphoma-dogs

Bautista-Alejandre A, Clifford C. About the novel drug for canine lymphoma. 

. January 6, 2025. Accessed February 14, 2025. 

https://www.dvm360.com/view/about-the-novel-drug-for-canine-lymphoma

Articles

Most major sections of the new animal drug application for Laverdia-CA1 have been deemed complete by the FDA, bringing the drug closer to approval

Laverdia-CA1's field trial ends, statistical analysis to begin 

Happy Friday dvm360 readers! We hope that everyone had a great week and are ready for the weekend. Did you know that we are almost officially 1 month away from our first Fetch conference of the year, 

? Join us in the Queen’s City for a weekend full of educational lectures from the best faculty around, networking opportunities with fellow professionals, and more! This is a conference you do not want to miss, so register here today!

Here is what was popular this week on dvm360.com:

The US Department of Agriculture (USDA) Animal and Plant Health Inspection (APHIS) 

 that dairy cattle in Nevada have been confirmed to have the H5N1 clade 2.3.4.4b genotype D1. 1, making it the first case of this genotype found in dairy cattle.

 the launch of AI Masses, the latest addition to its Vetscan Imagyst platform. This addition will use artificial intelligence to perform quick clinical screenings of common lymph node and subcutaneous lesion at the point of care.

 of The Vet Blast Podcast presented by dvm360, Kemba L. Marshall, MPH, DVM, DABVP (Avian), shared more about her book 

Diversity, Equity, and Inclusion in Veterinary Medicine 

with our host Adam Christman, DVM, MBA, including what inspired her to become an author. dvm360 and Marshall have also partnered together for a giveaway of her book, so head over to 

, has been reintroduced in Congress. The bill, endorsed by the American Veterinary Medical Association, will categorize xylazine as a Schedule III controlled substance and provide protection to animal care professionals that prescribe and administer it.

Bison and cattle imports from Mexico are set to resume soon, according to USDA APHIS, after pausing shipments in November 2024 due to 

 being detected in cattle in Mexico. APHIS and Mexico will be implementing extensive protocols for pre-clearance inspections and treatment.

Wrap up: Cattle and bison imports from Mexico to resume under new screwworm inspection protocol, and other news

A new, generic, non-steroidal anti-inflammatory drug (NSAID) is now available for managing osteoarthritis (OA) pain in horses. Aurora Pharmaceutical’s EquiCoxib is bioequivalent to the Equioxx brand oral paste (Boehringer Ingelheim) using firocoxib as the active ingredient.

Approved by the FDA in January 2024, EquiCoxib is a noninvasive, liquid formulation. The FDA permitted the application for EquiCoxib approval to differ in dosage form and strength from the brand product. An in vivo blood-level study in horses was conducted to demonstrate that the 9.0 mg/mL EquiCoxib oral solution is bioequivalent to the 8.2 mg/g Equioxx oral paste. Based on study data submitted to the FDA by Aurora Pharmaceutical, the agency determined that EquiCoxib is safe and effective when used according to its’ label.

EquiCoxib is indicated for oral administration once a day for up to 14 days in equine patients, and should not be injected. This therapy is available by prescription from a licensed veterinarian, and should not be used with other NSAIDs, corticosteroids or nephrotoxic medication.

"EquiCoxib is [a]… cost-effective option that doesn't compromise quality," Mike Strobel, DVM, MS, founder and CEO of Aurora Pharmaceutical, said in a news release.

 "We're excited to share our latest offering to horse owners and their veterinarians."

Aurora Pharmaceutical specializes in developing, manufacturing, and distributing animal health products. Based in Northfield, Minnesota, the company aims to serve veterinarians, livestock producers, and pet owners.

With EquiCoxib, Aurora Pharmaceutical is advising veterinarians to provide a client information sheet to the patient’s owner with every prescription and refill. Veterinary professionals and client should be aware of potential risks associated with firocoxib, and clients should also be advised to observed for signs of potential drug toxicity, according to the company.

The most common adverse effects associated with EquiCoxib include erosions and ulcers of the gums, tongue, lips and face, and kidney problems. As a NSAID, EquiCoxib may be associated with gastrointestinal, hepatic and renal toxicity. Additional adverse reactions of firocoxib use in horses may also include weight loss, colic, diarrhea, or icterus. Aurora Pharmaceutics recommends that veterinary teams advise clients to discontinue NSAID therapy and contact their veterinarian immediately if any adverse signs of intolerance are observed.

Aurora Pharmaceuticals delivers on FDA-approved generic for equine pain relief. Aurora Pharmaceuticals. February 13, 2025. Accessed February 14, 2025. 

https://prnmedia.prnewswire.com/news-releases/aurora-pharmaceutical-delivers-on-fda-approved-generic-for-equine-pain-relief-302376438.html

Freedom of information summary: ANADA 200-766. FDA. January 11, 2024. Accessed February 14, 2025. 

https://aurorapharmaceutical.com/wp-content/uploads/2024/03/FOI-Summary-oA-200-766-Approved-January-11-2024.pdf

EquiCoxib (firocoxib) oral solution for horses. Aurora Pharmaceuticals. Accessed February 14, 2025. 

https://aurorapharmaceutical.com/wp-content/uploads/2024/07/EquiCoxib-Product-Insert.pdf

Approved by the FDA in January 2024, EquiCoxib is a noninvasive, liquid formulation.

Generic therapy is available for managing OA pain in horses

Photo courtesy of Alex Sigmund, DVM, DACVO

This image was submitted by Alex Sigmund, DVM, DACVO; CEO of Insight Veterinary Eye Care based in Atlanta, Georgia, and known as The Vet Eye Guy to his more than 35,000 followers on Instagram. He wants every veterinarian to be comfortable with the basics of ophthalmology to improve patient care and client understanding. What ophthalmologic condition do you think the image shows?

Image quiz: Identify an eye condition

Entropion is a condition where the eyelid rolls inward, causing the periocular hair to rub against the cornea. It can affect any aspect of the upper or lower eyelids, but the lower, lateral aspect is most commonly affected. This constant friction leads to irritation and discomfort, and, if left untreated, can result in tearing, keratitis, and corneal ulcers. 

Although it may seem minor, entropion can severely impact a pet’s quality of life, causing pain and potential vision loss if ulcers worsen. Factors that affect the risk of entropion include eyelid fissure length, skull conformation, orbital anatomy, gender, and periocular facial folds.

Excessive tearing, especially from the lower lateral eyelid.

Chronic corneal ulceration, especially on the lower, lateral cornea.

There are 4 types of entropion. They are as follows:

This is the most common form and often affects breeds with specific facial structures and tissue development rates. Rottweilers, Great Danes, Mastiffs, and Labradors are a few common canine breeds. Persians, Maine coons, and domestic shorthairs are a few common feline breeds. Brachycephalic breeds commonly have medial entropion from facial folds. A polygenic inheritance is suspected with no identified genetic mutations for screening purposes.

Depending on breed, occurrence can occur at 4 to 7 months of age, but breeds such as the Shar-Pei and Chow Chow can have entropion as early as 2 to 6 weeks of age. Temporary tacking sutures or hyaluronic acid-based fillers can be used in young patients to allow them grow into their features. If closer to 6-12 months, then surgical intervention is likely needed.

This type of entropion occurs secondary to discomfort that can occur from severe conjunctivitis and corneal ulcers. With corneal pain, the eye becomes enophthalmic which allows the eyelids to roll inward and contact the eye which worsens the squinting and the entropion. Applying a topical anesthetic can temporarily eliminate the cause of discomfort and allow the eye’s position to relax to help diagnose this condition. If the entropion resolves, then a surgical option is not necessarily needed and a temporary procedure is needed, such as tacking sutures.

This form of entropion occurs from scar tissue from trauma. This trauma can be physical, such as an eyelid laceration, but it can also be from chronic, painful ocular disease, such as herpetic conjunctivitis especially in cats. Treatment commonly involves surgery.

The last form of entropion occurs from loss of orbital tissue (both muscle and fat). This can occur from aging, severe weight loss, hyperthyroidism, and neurogenic muscle atrophy. There is no reliable treatment for restoring orbital tissue mass, so surgically addressing the entropion is usually needed. Unfortunately, entropion can recur due to continued loss of orbital tissue. Hyaluronic acid-based filler agents can be used as a temporary nonsurgical route to address mild to moderate entropion.

Answer to identifying an eye condition

Becky Carstens arrived home one day to discover that her boyfriend had given Nellie, their doodle puppy, a zolpidem (Ambien) pill instead of the medication she was prescribed for her urinary tract infection. According to the release, Carstens has prescriptions for her dogs from 2 different veterinary clinics, one using a brown bottle and the other, which were Nellie’s, were in a blue bottle.

 However, Carstens' Ambien bottle also came in a brown bottle.

Carstens explained that she had run out of her Ambien and needed a refill, so she left the pill bottle on the counter next to her dogs’ medications. Having to leave the house, she asked her boyfriend to give their dog his medication, and he told her when she returned that he had given both dogs the medication. Carstens knew that Nellie’s UTI medication had run out, realizing that he had given Nellie the Ambien, she called the veterinarian immediately. Their veterinarian then encouraged them to call Pet Poison Helpline.

“Never keep your pet’s medication with any human medications,” expressed Renee Schmid, DVM, DABT, DABVT, a senior veterinary toxicologist and director of Veterinary Medicine at Pet Poison Helpline.

 “In fact, if you have multiple pets, you should also store their medications separately, as it is very easy to mix up bottles and severe effects may occur if unnecessary medication is given.”

Canines ingest entire bottle of calming chews

“Also, never give your pets their medications together, as you might drop a pill, and the other animal will beat you to it! Finally, make sure your pets aren’t around when you take your own medication, as that could also fall on the floor and become a deadly treat,” she continued.

Nellie was rushed to an urgent care facility after being given Ambien instead of her urinary tract infection medication (Image courtesy of Pet Poison Helpline)

Carstens brought Nellie to Urgent Pet Care in Omaha, Nebraska, where she provided the veterinary staff with her Pet Poison Helpline case number, where they then had access to their medical team to call Pet Poison Helpline and begin developing a treatment plan. The teams were worried about blood pressure changes, severe neurologic depression or agitation, and an increase in heart rate. The team at Urgent Pet Care induced vomiting by administering activated charcoal to absorb the toxin and then placed her on IV fluids. They monitored her closely overnight and provided supportive care.

Ambien is a human sleep medication that is designed to cause sleep and sedation in humans but can have the opposite effect on pets. If a pet ingests Ambien or any other common sleep medication, common signs to be on the lookout for are

At the end of the ordeal, Nellie’s veterinary bill was more than $1200, but thanks to pet insurance, after the deductible, 90% of the expenses were covered, including the cost of the call to Pet Poison Helpline.

“Pet Poison Helpline and pet insurance make for a good combination,” said Ricky Walther, DVM, chief medical officer at Pawlicy Advisor, the company that insured Nellie.

 “The experts at Pet Poison Helpline provide industry-leading pet toxicology advice, and having the 

 pet insurance ensures that you can make the best medical care decisions possible without worrying about the cost of treatment.”

All Toxin Tails installments from Pet Poison Helpline are designed to educate pet lovers and the veterinary community on the multiple types of poisoning pets face inside and out of the home. All pets featured were successfully treated and made a full recovery.

Medication Mix-up Poisons Doodle Puppy. News release. Pet Poison Helpline. February 12, 2025. Accessed February 13, 2025. https://www.prnewswire.com/news-releases/medication-mix-up-poisons-doodle-puppy-302373881.html

Ambien. Pet Poison Helpline. Accessed February 13, 2025. https://www.petpoisonhelpline.com/poison/ambien/

Nellie, a doodle puppy, was accidentally given Ambien instead of UTI medication 