{"id":29684,"date":"2022-03-25T14:33:54","date_gmt":"2022-03-25T14:33:54","guid":{"rendered":"http:\/\/tvp.tv-multi-theme.com.216-70-96-51.jvv2-rfnp.accessdomain.com\/?p=29684"},"modified":"2022-04-08T14:23:19","modified_gmt":"2022-04-08T14:23:19","slug":"imepitoin-in-behavioral-and-neurobehavioral-medicine","status":"publish","type":"post","link":"https:\/\/navc.sitepreview.app\/todaysveterinarypractice.com\/pharmacology\/imepitoin-in-behavioral-and-neurobehavioral-medicine\/","title":{"rendered":"Imepitoin in Behavioral and Neurobehavioral Medicine"},"content":{"rendered":"<p class=\"p1\"><span class=\"s1\">Imepitoin was developed as an anticonvulsant and has been used as an anticonvulsant in dogs alone or with other antiepileptic (AE) medications.<sup>1,2<\/sup> It has also been used for situational anxiety,<sup>3<\/sup> including anxiety that accompanies idiopathic epilepsy;<sup>4<\/sup> a number of canine fear and anxiety applications;<sup>5<\/sup> and fear of fireworks and storms.<sup>6,7<\/sup> It is licensed in Europe as Pexion (Boehringer Ingelheim, <\/span><a href=\"http:\/\/pexion.co.uk\"><span class=\"s2\">pexion.co.uk<\/span><\/a><span class=\"s1\">) as an atypical AE for dogs not responding to traditional AEs and for the situational treatment of fear of noises. It is licensed in the United States only for the latter application, again as Pexion, but not distributed in the U.S. at time of publication. To be successful in alleviating noise reactivity associated with anxiety and fear, it must be given by mouth twice a day, starting 2\u00a0days before the anticipated fear-provoking event (e.g., fireworks) and including the day of the event for 3 days of treatment.<\/span><\/p>\n<div class=\"su-box su-box-style-default\" id=\"\" style=\"border-color:#003d45;border-radius:3px;\"><div class=\"su-box-title\" style=\"background-color:#007078;color:#ffffff;border-top-left-radius:1px;border-top-right-radius:1px\">KEY POINTS<\/div><div class=\"su-box-content su-u-clearfix su-u-trim\" style=\"border-bottom-left-radius:1px;border-bottom-right-radius:1px\">\n<ul>\n<li class=\"p1\"><span class=\"s1\">Imepitoin (Pexion) is 1 of 2 medications licensed for the treatment of canine fear of noises. <\/span><\/li>\n<li class=\"p1\"><span class=\"s1\">Imepitoin was developed as an anticonvulsant and is a partial agonist of the benzodiazepine site of the gamma-aminobutyric acid A (GABAA) receptor. <\/span><\/li>\n<li class=\"p1\"><span class=\"s1\">Imepitoin has 12% to 21% the effect exerted by diazepam and is easily displaced by full agonists. <\/span><\/li>\n<li class=\"p1\"><span class=\"s1\">For use in fear of noises, the pivotal study showed that imepitoin must be given at 30 mg\/kg PO q12h for 3 days, starting 2\u00a0days prior to the expected noise event. <\/span><\/li>\n<li class=\"p1\"><span class=\"s1\">Ataxia is the most common adverse event and may last days after the initial 3-day treatment phase.<\/div><\/div><\/span><\/li>\n<\/ul>\n<h2 class=\"p2\">Mechanism of Action<\/h2>\n<p class=\"p1\"><span class=\"s1\">Imepitoin, an imidazolone structurally similar to phenytoin, is a partial agonist of the benzodiazepine site of the gamma-aminobutyric acid A (GABA<sub>A<\/sub>) receptor. As a partial agonist, it binds to activate the receptor, but at only partial efficacy relative to full agonists like diazepam and clonazepam (12% to 21% of the effect exerted by diazepam).<sup>8<\/sup> Like other low-affinity compounds, it has a short receptor interaction time and is easily displaced by full agonists.<span class=\"Apple-converted-space\">\u00a0<\/span><\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">Imepitoin also blocks voltage-gated calcium channels in a dose-dependent manner and may stimulate the barbiturate binding site of the GABA<sub>A<\/sub> receptor. These actions activate the GABA<sub>A<\/sub> receptor, stimulating inhibition of activity, and can counteract the excitatory effects of the amino acid glutamate. Glutamate spikes have been implicated in stroke; idiopathic epilepsy affecting the hippocampus and frontal cortex in humans, rodents, and cats; and behavioral pathologies involving impulsive components.<span class=\"Apple-converted-space\">\u00a0<\/span><\/span><\/p>\n<h2 class=\"p2\">Efficacy<\/h2>\n<h3 class=\"p3\">Epilepsy<\/h3>\n<p class=\"p1\"><span class=\"s1\">Expression of GABA<sub>A<\/sub> receptors is affected in epilepsy; accordingly, medications that affect various aspects of the GABA<sub>A<\/sub> receptor and potentiate its inhibitory effect may act as AEs. Drug-resistant epilepsy may be due to the activity of large numbers of GABA<sub>A<\/sub> receptor subtypes that function differently.<span class=\"Apple-converted-space\">\u00a0<\/span><\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">Imepitoin was effective in nonrefractory, newly diagnosed idiopathic epilepsy in dogs in a clinical trial.<sup>1<\/sup> In an open-label trial using imepitoin as an add-on medication to phenobarbital in dogs with drug-resistant idiopathic epilepsy, the combination of imepitoin and phenobarbital decreased monthly seizure frequency when imepitoin was started at dosages as low as 5 mg\/kg PO q12h.<sup>2<\/sup> In one treatment group, if imepitoin was not effective, phenobarbital was added, with effects similar to those of supplementing the original dose of phenobarbital with imepitoin. This result suggests intrinsic patient population heterogeneity in activation of the GABA<sub>A<\/sub> receptor in dogs considered drug resistant. Whether this population heterogeneity is due to functional variability in receptor subtypes is unknown. Supplementation was not effective in a group of dogs with cluster seizures,<sup>2<\/sup> suggesting that multiple mechanisms for seizures exist in these clinically polymorphic variants.<span class=\"Apple-converted-space\">\u00a0<\/span><\/span><\/p>\n<h3 class=\"p3\">Fear and Anxiety<\/h3>\n<p class=\"p1\"><span class=\"s1\">Imepitoin has been variously dosed and trialed for the treatment of nonspecific canine fears and anxieties,<sup>5<\/sup> canine generalized anxiety disorder,<sup>3<\/sup> comorbid anxiety in dogs with idiopathic epilepsy,<sup>4<\/sup> fear of noises associated with fireworks,<sup>6<\/sup> and fear of noises associated with storms.<sup>7<\/sup><\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">In an open-label, non-blinded, non\u2013placebo-controlled case series study of 20 dogs with various fear- and anxiety-related concerns, only 4 of which did not have an association with noise, 19 dogs were treated with a behavior modification program and imepitoin starting at 10 mg\/kg and increasing to a maximum of 30 mg\/kg PO q12h for 11 to 19 weeks.<sup>5<\/sup> Results for the 17 dogs that finished the study were based on self-reported, client-scaled assessments at baseline and after treatment and on client diaries, which were used to calculate average weekly fear-anxiety reaction scores and average weekly global fear-anxiety scores. Clients reported lower reaction scores between baseline and week 1 and baseline and week 11. There were 7 adverse events, including 2 related to sedation.<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">In a placebo-controlled, randomized, double-blind, single-site study, dogs with generalized anxiety disorder were treated for 3 days at 20 mg\/kg PO q12h.<sup>3<\/sup> Assessment was through response to a series of 14\u00a0provocative tests at baseline and after treatment and comparison of plasma cortisol levels for 54 dogs. No significant effect was seen for the behavioral tests. A statistically significant reduction in serum cortisol levels was associated with imepitoin treatment, and initial serum cortisol levels correlated with severity of the condition. Adverse events were reported in 13 dogs in the imepitoin group and 12 in the control group. <\/span>Ataxia was reported only in dogs in the imepitoin group.<\/p>\n<p class=\"p1\"><span class=\"s1\">An online survey of 85 owners of dogs with idiopathic epilepsy treated with imepitoin for comorbid anxiety evaluated effects on dog-directed fear, human stranger\u2013directed fear, non-social fear, pain sensitivity, and separation-related behavior.<sup>4<\/sup> Treatment was for a minimum of 4 weeks. No statistically significant differences were noted in any measures when scores obtained before and after treatment were compared. Seizure frequency did decrease. Dogs received imepitoin at dosages of 10 to 37.5 mg\/kg PO q12h. Adverse events primarily occurred within the first 2\u00a0weeks of treatment; the most common adverse effects were polyphagia and sedation.<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">A placebo-controlled, randomized, double-blind, multisite study of 238 dogs with fear of fireworks used a 16-item owner-completed assessment of fear and anxiety to measure response to treatment.<sup>6<\/sup> Dogs in the imepitoin group were treated for 3 days at 30 mg\/kg PO q12h. A statistically significant effect was noted for dogs in the imepitoin group. Ataxia occurred in more than 20% of the treated dogs, with half of the dogs taking 2 or more days to recover.<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">Longer-term effects of imepitoin on fear associated with storms were evaluated in a double-blind, placebo-controlled, randomized study in which 30 dogs received imepitoin (30 mg\/kg PO q12h) for 28 days.<sup>7<\/sup> Effects were evaluated using owner ratings of intensity for 16 common behaviors exhibited by dogs fearful of noises. Summary scores were compared with baseline and between groups. Clients also kept storm logs about their dog\u2019s behavioral responses. Mild\/moderate adverse effects were seen in 26 dogs, 24 of which were in the treatment group (80% of imepitoin-treated dogs), and ataxia was the most common adverse event. Adverse events resulted in withdrawal of 10 imepitoin-treated dogs from the study; there were no withdrawals in the control group. Imepitoin was statistically superior to placebo in both the logs and the scored ratings at weeks 2 and 4, but not continuously. Clients significantly reported beneficial effects on non-storm noises.<\/span><\/p>\n<h2 class=\"p2\">Clinical Applications<\/h2>\n<p class=\"p1\"><span class=\"s1\">The established clinical applications for imepitoin include interventional use as a supplemental medication for refractory or incompletely responsive idiopathic epilepsy in newly diagnosed dogs, prophylactic use over 3 days for dogs with a known heightened reactivity to or fear of noise when a known noise trigger is expected (e.g., fireworks), and both prophylactically and interventionally for dogs with known fear of storms where exposure is regular or chronic over at least a month.<\/span><\/p>\n<h2 class=\"p2\">Recommended Dosage<\/h2>\n<p class=\"p1\"><span class=\"s1\">Pexion is available (in Europe) in 100- and 400-mg scored tablets and dosed by weight at a range of 10 to 30 mg\/kg every 12 hours. For idiopathic epilepsy, the dosage starts at 5 to 10 mg\/kg PO q12h and increases by 50% to 100% weekly depending on degree of resolution.<sup>1,2<\/sup> In the study of dogs with generalized anxiety disorder, the dose was 20 mg\/kg PO q12h for 3\u00a0consecutive days.<sup>3<\/sup> Similar dosing is recommended for fear of noises, although the commonly recommended dosage is 30 mg\/kg PO q12h for 3 consecutive days for fireworks<sup>6<\/sup> (the licensing dosage) and up to 28 days for storms.<sup>7<\/sup><\/span><\/p>\n<h2 class=\"p2\">Pharmacokinetics<\/h2>\n<p class=\"p1\"><span class=\"s1\">High plasma levels of imepitoin are found within 30\u00a0minutes of dosing, with maximum plasma levels not reached in dogs until 2 to 3 hours after administration due to slow absorption associated with low solubility.<sup>8<\/sup> Plasma binding is only 55% and terminal half-life is 2\u00a0hours in dogs. Feeding and gender have no effect on outcome. Most (&gt;90%) is excreted in feces. No adverse signs were seen after 28 days of chronic treatment followed by abrupt cessation, and imepitoin induction of cytochrome P-450 enzymes appears minimal, rendering metabolism-induced drug interactions unlikely, but interactions with CYP1A1 are possible. Induction of liver enzymes does not occur at therapeutic dosages.<sup>8<\/sup><\/span><\/p>\n<h2 class=\"p2\">Benefits and Adverse Effects\/Contraindications<\/h2>\n<p class=\"p1\"><span class=\"s1\">Imepitoin is not water soluble and may benefit from low pH environments. Inhibition of stomach acid by proton pump inhibitors (i.e., omeprazole) may interfere with the action of imepitoin. Notable adverse effects reported in published trials include sedation and ataxia lasting for days.<sup>3-7<\/sup> Because the medication must also be given for 3 days, the sedation and ataxia must be considered as adverse events in any discussion of usage and cannot be viewed as transient.<span class=\"Apple-converted-space\">\u00a0<\/span><\/span><\/p>\n<div class=\"su-box su-box-style-default\" id=\"\" style=\"border-color:#003d45;border-radius:3px;\"><div class=\"su-box-title\" style=\"background-color:#007078;color:#ffffff;border-top-left-radius:1px;border-top-right-radius:1px\">Dexmedetomidine: An Overview<\/div><div class=\"su-box-content su-u-clearfix su-u-trim\" style=\"border-bottom-left-radius:1px;border-bottom-right-radius:1px\">Any licensed behavioral medication compound is an important addition to the behavioral medicine pharmacopeia. There are currently 2 medications with a license for use in the treatment of canine fear of noises: imepitoin (Pexion) and oral-transmucosal (OTM) dexmedetomidine (Sileo; Zoetis, <a href=\"http:\/\/zoetisus.com\">zoetisus.com<\/a>). However, they are very different medications and have different applications and different adverse event profiles due to their pharmacology.<\/p>\n<p>OTM dexmedetomidine is an \u03b1-agonist. It is delivered as a gel to the gums and can be given up to 5 times a day, with applications separated by 90 to 120 minutes.1 Only 4% of the compound is absorbed into the systemic circulation. In a placebo-controlled, randomized, double-blind, multisite study of 182 dogs using a standardized owner assessment of specific signs; owner assessment of overall treatment effect; and a scored, benchmarked functional assessment to assess any undesirable sedative effects, dexmedetomidine was found to have a significant effect on behavioral signs, with an odds ratio of 3.4 (P &lt;.0001).1 Most (85%) dexmedetomidine-treated dogs experienced no effects of sedation in the functional assessment and only 7 (7.9%) dogs in the interventional group and 2 in the control group were sufficiently sedated that they were difficult to rouse.<sup>1<\/sup> The adverse event profile of dexmedetomidine is superior to that for imepitoin.<\/p>\n<p>OTM dexmedetomidine can be given prophylactically or interventionally. Effects are seen within 20 minutes, with peak effects within an hour, making it the preferred choice for situational noise that is not expected or cannot be anticipated 2 days in advance. Additionally, repeated dosing benefits the dog and may help to improve the pathology, as indicated by a decreased need for future dosing. This result may suggest that dogs can learn to become less fearful when treated with repeated dosing of OTM dexmedetomidine.<sup>2<\/sup><\/p>\n<p><strong>References<\/strong><br \/>\n1. Korpivaara M, Laapas K, Huhtinen M, et al. Dexmedetomidine oromucosal gel for noise-associated acute anxiety and fear in dogs\u2014a randomised, double-blind, placebo-controlled clinical study. Vet Rec. 2017;180(14):356. doi: 10.1136\/vr.104045<br \/>\n2. Gruen M, Case BC, Robertson JB, et al. Evaluation of repeated dosing of a dexmedetomidine oromucosal gel for treatment of noise aversion in dogs over a series of noise events. Vet Rec. 2020;187(12):489. doi: 10.1136\/vr.106046<\/div><\/div>\n<h2 class=\"p2\">Conclusion<\/h2>\n<p class=\"p1\"><span class=\"s1\">No one medication works for all dogs in all circumstances in behavioral medicine. Having a choice of licensed compounds, each of which may help an individual dog at different times or help different dogs, benefits patients.<span class=\"Apple-converted-space\">\u00a0<\/span><\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">Imepitoin, while licensed a few years ago, is still not broadly available globally.<span class=\"Apple-converted-space\">\u00a0<\/span><\/span><\/p>\n<p class=\"p4\"><strong>Disclosure<\/strong><\/p>\n<p class=\"p6\"><span class=\"s1\">Dr. Overall has consulted for all of the drug companies that develop behavioral medicine for dogs and cats. She consults for Orion Pharmaceuticals and helped design the study that licensed Sileo.<span class=\"Apple-converted-space\">\u00a0<\/span><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Imepitoin is an anticonvulsant medication, as well as being used for canine fear and anxiety applications.<\/p>\n","protected":false},"author":9,"featured_media":29602,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"iawp_total_views":2634,"footnotes":""},"categories":[400],"tags":[13],"class_list":["post-29684","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-march-april-2022","tag-peer-reviewed","column-focus-on-pharmacology","clinical_topics-behavior","clinical_topics-pharmacology"],"acf":{"hide_sidebar":false,"hide_sidebar_ad":false,"hide_all_ads":false},"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v24.7 (Yoast SEO v27.3) - 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