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Drug Class Review Newer Anticonvulsant Agents 28:12:92 Anticonvulsants, Other

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Drug Class Review Newer Anticonvulsant Agents 28:12:92 Anticonvulsants, Other Drug Class Review Newer Anticonvulsant Agents 28:12:92 Anticonvulsants, Other Brivaracetam (Briviact®) Clobazam (Onfi®) Eslicarbazepine (Aptiom®) Ezogabine (Potiga®) Felbamate (Felbatol®, others) Gabapentin (Neurontin®) Lacosamide (Vimpat®, others) Lamotrigine (Lamictal®, others) Levetiracetam (Keppra®, others) Oxcarbazepine (Trileptal®, Oxtellar XR®, others) Perampanel (Fycompa®) Pregabalin (Lyrica ®) Rufinamide (Banzel®) Tiagabine (Gabitril®) Topiramate (Topamax ®, Trokendi XR, Qudenxi XR, others) Vigabatrin (Sabril®) Zonisamide (Zonergan ®, others) Final Report June 2016 Review prepared by: Vicki Frydrych, Clinical Pharmacist University of Utah College of Pharmacy Copyright © 2016 by University of Utah College of Pharmacy Salt Lake City, Utah. All rights reserved. Table of Contents Introduction ....................................................................................................................... 1 Table 1: Comparison of Newer Anticonvulsant Agents ...................................... 2 Table 2: FDA-Approved Indications for Newer Anticonvulsant Agents ........... 16 Disease Overview ............................................................................................................ 17 Table 3: The International League Against Epilepsy Classification of Seizures ............................................................................................... 19 Table 4: Newer Antiepileptic Drugs Which May Exacerbate Seizures ............. 21 Table 5: Clinical Practice Guideline Recommendations for Epilepsy .............. 22 Pharmacology .................................................................................................................. 34 Table 6: Pharmacokinetics of the Newer Antiepileptic Drugs .......................... 38 Table 7: Newer Antiepileptic Drug Metabolic Pathways and in-vitro Hepatic Enzyme Effects .............................................................................. 41 Table 8: Drug Interactions Between Newer Antiepileptic Agents .................... 41 Table 9: Interactions Between Newer Anticonvulsant Medications and Other Drugs ........................................................................................ 43 Special Populations ......................................................................................................... 44 Table 10: Special Populations ............................................................................ 46 Methods ........................................................................................................................... 51 Clinical Efficacy .............................................................................................................. 51 Safety ............................................................................................................................... 59 Table 11: Adverse reactions associated with the newer antiepileptic agents ..... 61 Comparative Evidence .................................................................................................... 63 Summary: ........................................................................................................................ 69 REFERENCES ................................................................................................................ 71 Appendix 1: Clinical Trials Evaluating the Efficacy of Antiepileptic Agents for use in Seizure Disorders .............................................. 83 i I ntroduction The history of seizures dates back to the Babylonians. Ancient peoples have considered seizures indicative of demonic possession; hence, the word “seizure” comes from the Latin, sacire “to take possession of”. Greeks believed it to be a curse of the gods and referred to it as the Sacred Disease.1,2 The first medications used for seizures included bromide in the 19th century and phenobarbital as the first synthetic organic compound in the early 20th century.3 The medications found useful to control seizures are diverse in mechanism of action and pharmacologic class, including hydantoins (phenytoin, fosphenytoin, ethotoin), anti-seizure barbiturates (phenobarbital, pentobarbital), iminostilbenes (carbamazepine), succinimides (ethosuximide), valproic acid and derivatives, benzodiazepines (clonazepam, clorazepate, midazolam, diazepam, lorazepam, clobazam) and others (acetazolamide, brivaracetam, eslicarbazepine, ezogabine, felbamate, gabapentin, lacosamide, lamotrigine, levetiracetam, magnesium sulfate, oxcarbazepine, perampanel, pregabalin, rufinamide, tiagabine, topiramate, vigabatrin and zonisamide). Newer agents were developed in an attempt to minimize adverse effects, drug interactions, safety concerns and offer an improved risk:benefit ratio.4 Some of these agents are new chemical entities and others are analogues of currently available medications. Eslicarbazepine and oxcarbazepine are carbamazepine derivatives, pregabalin is a gabapentin derivative and brivaracetam is a levetiracetam derivative.5 This report will focus on the comparative clinical efficacy and safety evidence of the following “newer” agents, brivaracetam, clobazam, eslicarbazepine, ezogabine, felbamate, gabapentin, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, perampanel, pregabalin, rufinamide, tiagabine, topiramate, vigabatrin and zonisamide for use in seizure disorders and epilepsies. One combination agent (topiramate/phentermine, Qsymia®) used exclusively for weight loss is not included in this review. All 17 agents are available in oral tablet or capsule formulations.6-8 Ten of the seventeen agents are available for administration as oral liquid formulations: clobazam, felbamate, gabapentin, oxcarbazepine (suspension), brivaracetam, clobazam, gabapentin lacosamide, levetiracetam, pregabalin, rufinamide (solution) and vigabatrin (powder for solution). Topiramate is available as both immediate- and extended-release oral sprinkle formulations. Three agents are available for injection: brivaracetam, lacosamide and levetiracetam (also available premixed in sodium chloride). Lamotrigine is available in chewable/dispersible tablets, orally disintegrating tablets and titration kits. Lamotrigine and gabapentin are available as starter packs. Five extended- release oral dosage form products are available: gabapentin, lamotrigine, levetiracetam, oxcarbazepine, and topiramate. These medications are each FDA approved for use in at least one seizure disorder, including infantile spasms, Lennox-Gastaut syndrome, myoclonic seizures, partial-onset seizures (mono/adjunct therapy), partial-onset seizures with complex symptomatology, refractory complex partial seizures and tonic-clonic seizures (mono/adjunct therapy). Some of the agents have additional, non-seizure disorder indications including bipolar disorder (lamotrigine), fibromyalgia (pregabalin), migraine prophylaxis (topiramate), neuropathic pain (pregabalin) and postherpetic neuralgia (gabapentin and pregabalin). Three of the agents are DEA Schedule V medications (lacosamide, ezogabine, pregabalin). A comparison of the newer antiepileptic agents is found in Table 1 and 2. 1 Table 1. Comparison of Newer Anticonvulsant Agents 7,8 3,6,8- 30 Generic Formulations Indications/Uses Oral Dose Range, Adults Oral Dose Range, Pediatrics Available Brivaracetam Oral Tablets: 10 mg, 25 mg, Partial-onset seizures: Partial-onset Seizures: 50-200 mg daily, 16 years and older: No 50 mg, 75 mg, 100 mg Adjunctive therapy in the divided twice a day (Briviact®) • 50-200 mg daily, divided twice treatment of partial-onset Solution; oral: 10 mg/mL a day seizures in adults and Injection, solution: 10 mg/mL adolescents 16 years and older with epilepsy Clobazam Oral Suspension: 2.5 mg/mL Lennox-Gastaut syndrome: >30 kg: ≤30 kg: No Adjunctive treatment in patients (Onfi®) Oral Tablet: 10 mg, 20 mg • Initial dosage: 5 mg twice daily for • Initial dosage: 5 mg once daily, ≥2 years 7 days then increase to 10 mg twice increase after > 1 week to 5 mg daily and after 14 days to 20 mg twice daily and then to 10 mg twice daily. twice daily. < 30 kg: >30 kg: • Initial dosage: 2.5 mg twice daily for • Initial dosage: 5 mg twice daily 7 days then increase to 5 mg twice for ≥1 week, then increase to daily and after 14 days to 10 mg 10 mg twice daily and 20 mg twice daily. twice daily at intervals of at least 1 week. Eslicarbazepine Oral Tablet: 200 mg, 400 mg, Partial-onset seizures: Partial-onset seizures: Monotherapy Not established No Acetate 600 mg, 800 mg Monotherapy or adjunctive 800-1600 mg once daily therapy in the treatment of (Aptiom®) • Adjunctive therapy 800-1600 mg partial-onset seizures once daily not recommended with oxcarbazine • Higher doses may be required with enzyme inducing antiepileptic drugs (phenobarbital, phenytoin, primidone) • Dose adjustment of either carbamazepine or eslicarbazepine may be required when used together 2 Generic Formulations Indications/Uses Oral Dose Range, Adults Oral Dose Range, Pediatrics Available Ezogabine Oral Tablet: 50 mg, 200 mg, Partial-onset seizures: As Partial-onset seizures: Not established No 300 mg, 400 mg adjunctive treatment for partial- (Potiga®) 200-400 mg three times daily; onset seizures in patients 18 Maximum 1200 mg/day years and older who have responded inadequately to Schedule V several alternative treatments and for whom the benefits outweigh the risk of retinal abnormalities and potential decline in visual acuity Felbamate Oral Suspension:600 mg/5 ML Not indicated as a first-line Partial seizure, With and without Partial seizure,
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