Liavium-CA1 Receives FDA Conditional Approval for Canine Neuropathic Pain

Pegasus Laboratories, Inc. (Pegasus), under its registered trademark PRN® Pharmacal brand, today announced that the U.S. Food and Drug Administration (FDA) has granted conditional approval to Liavium®-CA1 (pregabalin chewable tablets), a first-in-class therapy for dogs with Chiari-like malformation and syringomyelia (CM/SM), a painful neurologic condition that has long flown under the diagnostic radar.

"Liavium-CA1 signals a turning point in canine pain management by providing veterinarians a first-of-its-kind option to effectively manage neuropathic pain," said Dr. Heather Davis, DVM, PhD, DACVS-LA, Senior Director of Medical Affairs and Veterinary Services at Pegasus. "The conditional approval of Liavium-CA1 reflects Pegasus' ongoing commitment to delivering innovative solutions that address unmet needs in specialty animal health, supporting veterinarians and pet caretakers in improving the lives of the animals they care for."

CM/SM is a serious neurologic condition that causes chronic, often debilitating pain in dogs. Its hallmark signs of phantom scratching, vocalization, and sensitivity around the head and neck are routinely mistaken for anxiety, behavioral changes, or aging, leaving many dogs undiagnosed for years. While any dog can be affected, the condition is most common in small and toy breeds, particularly the Cavalier King Charles Spaniel.

FDA conditional approval of Liavium-CA1 follows results from a pilot study demonstrating its ability to manage pain and clinical signs associated with CM/SM, while also proving its ease of use in everyday veterinary practices. Pegasus, which acquired TriviumVet® in 2025, continues to study Liavium-CA1 in a pivotal clinical trial across investigator sites in the United States. Conditional approval, which is available for certain animal drugs that address a serious or life-threatening disease or an unmet animal health need, allows Pegasus to legally market Liavium®-CA1 while TriviumVet continues to collect the effectiveness data required for full approval, providing veterinarians with access to this therapy sooner.

Liavium-CA1 is slated to be available in 30 mg, 90 mg, and 180 mg beef-flavored chewable tablet strengths (the 90 mg tablet is scored for splitting) to accommodate dogs weighing approximately 6.6 to 50 pounds, by prescription from a licensed veterinarian. As a federally controlled substance (C-V), it is subject to state and federal prescribing, dispensing, and record-keeping requirements.

Indications and Important Safety Information

Indication: Liavium®-CA1 is indicated for the management of pain and clinical signs associated with Chiari-like malformation and syringomyelia in dogs.

Important Safety Information: Liavium-CA1 (pregabalin chewable tablets) is conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-606. Liavium-CA1 is a Schedule V controlled substance and should be handled and stored according to federal and state controlled-substance requirements. Based on publications in the scientific literature, the following adverse reactions are associated with administration of pregabalin in dogs: somnolence, increased appetite, decreased activity, increased water intake, decreased body temperature or hypothermia, ataxia and sedation. Liavium-CA1 has not been evaluated in dogs with renal disease. Pregabalin is excreted by the kidneys and an adjustment of the pregabalin dose in dogs with renal disease may be necessary. Liavium-CA1 has not been evaluated in dogs that are pregnant, nursing or intended for breeding. If the dog vomits after product administration, avoid skin contact with vomit and any tablet remnants, use impervious gloves during cleaning up and wash hands afterwards. Women who are pregnant who may become pregnant or are breastfeeding should take particular care to avoid contact with pregabalin. Not for human use. Keep out of reach of children. See prescribing information for complete details regarding adverse events, warnings, and precautions.