The U.S. Food and Drug Administration (FDA) has granted conditional approval to Liavium-CA1 (pregabalin chewable tablets) for dogs with Chiari-like malformation and syringomyelia (CM/SM), a painful neurologic condition that is often underdiagnosed. BigStock The neurologic condition occurs when a dog’s skull is too small for its brain, disrupting cerebrospinal fluid flow and causing painful fluid-filled pockets along the spinal cord. According to the FDA, “These pockets swell and compress nerve fibers in the spinal cord, causing pain or discomfort that may make a dog cry out when its head, neck, or shoulders are touched. Dogs with CM may scratch themselves without any apparent reason (phantom scratching) or have trouble with walking or bowel movements due to increased pressure in the skull.” Pregabalin, the active ingredient in the medication, works by reducing neurotransmitters that send pain signals through the spinal cord. The prescription-only drug from Pegasus Laboratories/PRN Pharmacal is administered orally twice daily with food and cannot be accurately dosed in dogs under 3 kg (6.6 lbs.). It will be available by veterinary prescription in 30 mg, 90 mg, and 180 mg beef-flavored chewable tablets, including a scored 90 mg tablet for flexible dosing in dogs weighing about 3 to 23 kg (6.6 to 50 lbs.). As a Schedule V controlled substance, the drug is subject to federal and state prescribing, dispensing, and record-keeping regulations. “Liavium-CA1 signals a turning point in canine pain management by providing veterinarians a first-of-its-kind option to effectively manage neuropathic pain,” says Heather Davis, DVM, PhD, DACVS-LA, senior director of Medical Affairs and Veterinary Services at Pegasus Laboratories/PRN Pharmacal. “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.” The company has up to five years to provide additional effectiveness data required for full FDA approval.
