{"id":1207,"date":"2013-03-01T00:00:25","date_gmt":"2013-03-01T05:00:25","guid":{"rendered":"http:\/\/rhochistj.org\/RhoChiPost\/?p=1207"},"modified":"2014-02-24T16:30:36","modified_gmt":"2014-02-24T21:30:36","slug":"new-fda-approval-fycompa-treat-seizures","status":"publish","type":"post","link":"https:\/\/rhochistj.org\/RhoChiPost\/new-fda-approval-fycompa-treat-seizures\/","title":{"rendered":"New FDA Approval: Fycompa\u00ae to Treat Seizures"},"content":{"rendered":"

By: Bhavini Shah, PharmD Candidate c\/o 2013<\/strong><\/p>\n

\u00a0–<\/strong><\/p>\n

Fycompa\u00ae (perampanel) has received the U.S. Food and Drug Administration (FDA) approval for the adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older.1\u00a0 <\/sup>The drug, manufactured by Eisai Inc., is already approved for use in Iceland, Norway, and the European Commission.<\/p>\n

Epilepsy, sometimes referred to as\u00a0seizure disorder, <\/em>is defined by the occurrence of at least two unprovoked seizures separated by 24 hours.2<\/sup>\u00a0 A seizure is a temporary disturbance in brain function in which groups of nerve cells in the brain signal abnormally and excessively.3<\/sup>\u00a0 Partial seizures, the most common type of seizure seen in people with epilepsy, affect only a limited or localized area of the brain; however they can quickly spread to other parts of the brain.2,3<\/sup><\/p>\n

According to the Centers of Disease Control and Prevention (CDC), about two million people in the United States have epilepsy and more than one-third of people with epilepsy experience seizures despite taking current available treatments.3\u00a0 <\/sup>Fycompa\u00ae<\/sup> is the first and only licensed anti-epileptic drug\u00a0(AED) to selectively target AMPA receptors, a receptor in the brain which plays a critical role in the spread of epileptic seizures.1,4,5<\/sup> \u00a0This drug reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors.4,5<\/sup><\/p>\n

The approval of Fycompa\u00ae<\/sup> was primarily based on three Phase III studies (304, 305, and 306).\u00a0 All three studies \u2013 which\u00a0 were multi-center, randomized, double-blind, placebo-controlled, dose-escalation, and parallel group studies \u2013 evaluated the efficacy and safety of perampanel compared to a placebo given as adjunctive therapy in patients age 12 years and older with partial-onset seizures.\u00a0 In the first study, the percentage of patients who experienced a decrease in seizure frequency of at least 50% was 37.6% for patients taking 8 mg Fycompa and 36.1% for patients taking 12 mg Fycompa, compared with 26.4% of patients taking placebo. 6<\/sup>\u00a0 In the second study, 33.3% and 33.9% of patients taking 8 mg and 12 mg Fycompa respectively showed a decrease in seizure frequency of at least 50%, compared with 14.7% of patients taking placebo.7<\/sup>\u00a0 The third study showed a significant decrease in seizure frequency only in patients taking 4 mg and 8 mg Fycompa, but not in patients taking a dose of 2 mg.8 <\/sup>\u00a0These studies demonstrated that Fycompa\u00ae<\/sup> significantly reduced seizure frequency in patients with partial-onset seizures with or without secondarily generalized seizures.6,7,8<\/sup><\/p>\n

Fycompa\u00ae<\/sup> must be titrated in order to optimize the balance between efficacy and tolerability.4<\/sup>\u00a0 It should be used with caution in elderly, taking into account the drug interaction potential in poly-medicated patients.6,7,8\u00a0 <\/sup>Dose adjustment is not required in patients with mild renal impairment; however, dose increases in patients with mild and moderate hepatic impairment should be based on clinical response and tolerability.4<\/sup><\/p>\n

Fycompa\u00ae<\/sup> has the benefit of convenient, once-daily dosing at bedtime and is the only third generation partial epilepsy treatment approved to treat adolescents with epilepsy from launch. 4\u00a0 \u00a0<\/sup>Despite the various benefits, the drug does come with a host of potential side effects.\u00a0 A boxed warning flags the risks of life-threatening neuropsychiatric side effects including mood changes and other mental disturbances, including aggression, anxiety, and paranoia.4 <\/sup>\u00a0More common side effects include dizziness and weight gain.<\/p>\n

\n

The FDA has recommended that Fycompa\u00ae<\/sup> be classified by the U.S. Drug Enforcement Administration (DEA) as a scheduled drug.1 <\/sup>\u00a0The DEA will review the FDA’s recommendation and determine the final scheduling designation. \u00a0Once the DEA has provided the final scheduling designation, Eisai will announce when Fycompa\u00ae<\/sup> will be available to patients and physicians in\u00a0the United States.<\/p>\n<\/div>\n

SOURCES:<\/strong><\/span><\/p>\n

    \n
  1. FDA approves Fycompa to treat seizures. Avaialable at http:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm325038.htm.<\/a> Accessed Dec 27, 2012.<\/li>\n
  2. Rogers SJ, Cavazos JE. Chapter 65. Epilepsy. In: Talbert RL, DiPiro JT, Matzke GR, Posey LM, Wells BG, Yee GC, eds.\u00a0Pharmacotherapy: A Pathophysiologic Approach<\/i>. 8th ed. New York: McGraw-Hill; 2011.\u00a0http:\/\/www.accesspharmacy.com\/content.aspx?aID=7985219.<\/a> Accessed December 29, 2012.<\/li>\n
  3. Centers for Disease Control and Prevention: Epilepsy. Available at http:\/\/www.cdc.gov\/epilepsy\/.<\/a> Accessed Dec 27, 2012.<\/li>\n
  4. Fycompa [package insert]. Available at: http:\/\/ http:\/\/www.fycompa.eu\/.<\/a> Accessed Dec 27, 2012.<\/li>\n
  5. Rogawski MA. Revisiting AMPA receptors as an antiepileptic drug target. Epilepsy Curr. 2011(2);11;56-63.<\/li>\n
  6. French J, Krauss G, Biton V et al. Adjunctive perampanel for refractory partial-onset seizures; Randomized phase III study 304. Neurology 2012; 79: 589-596.<\/li>\n
  7. French J, Krauss G, Steinhoff B et al. Evaluation of adjunctive perampanel in patients with refractory partial-onset seizures: Results of a randomized global phase III study 305. Epilepsia 2012<\/li>\n
  8. Krauss G, Serratosa J, Villanueva V et al.
    \nRandomized phase III study 306: Adjunctive perampanel for refractory partial-onset seizures. Neurology 2012; 78:1408\u20131415<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    By: Bhavini Shah, PharmD Candidate c\/o 2013 \u00a0– Fycompa\u00ae (perampanel) has received the U.S. Food and Drug Administration (FDA) approval for the adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older.1\u00a0 The drug, manufactured by Eisai Inc., is already approved for use in Iceland,…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7,4],"tags":[190,343,2245,58,2243,1160,198,102,15,60,162,163,2021,13,2227,2232,35,314,1025,67,725,363,968,1625,1026,55,220,144,187,21,1161,16,623,59,1061],"class_list":["post-1207","post","type-post","status-publish","format-standard","hentry","category-clinical","category-featured","tag-account","tag-and","tag-approval","tag-brain","tag-cdc","tag-control","tag-daily","tag-december","tag-disease","tag-disorder","tag-disturbance","tag-dose","tag-double","tag-drug","tag-ebola-virus-disease","tag-fda","tag-food","tag-for","tag-fycompa","tag-hepatic","tag-mg","tag-of","tag-one","tag-or","tag-perampanel","tag-renal","tag-review","tag-seizure","tag-side","tag-study","tag-therapy","tag-treatment","tag-type","tag-weight","tag-with"],"views":742,"_links":{"self":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/posts\/1207","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/comments?post=1207"}],"version-history":[{"count":0,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/posts\/1207\/revisions"}],"wp:attachment":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/media?parent=1207"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/categories?post=1207"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/tags?post=1207"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}