{
 "query": "lacosamide",
 "ingredient": "lacosamide",
 "slug": "lacosamide",
 "rxcui": "623400",
 "brands": [
  "Vimpat",
  "Motpoly"
 ],
 "names": [
  "lacosamide"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 49,
   "INTRAVENOUS": 20
  },
  "boxed_warning": "",
  "indications_and_usage": "Lacosamide is indicated for: \u2022 Treatment of partial-onset seizures in patients 4 years of age and older ( 1.1 ) 1.1 Partial-Onset Seizures Lacosamide is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Additional pediatric use information is approved for UCB, Inc.'s VIMPAT \u00ae (lacosamide) tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
  "contraindications": "None. None ( 4 )",
  "warnings_and_cautions": "\u2022 Monitor patients for suicidal behavior and ideation ( 5.1 ) \u2022 Lacosamide may cause dizziness and ataxia ( 5.2 ) \u2022 Cardiac Rhythm and Conduction Abnormalities: Obtaining ECG before beginning and after titration to steady-state maintenance is recommended in patients with underlying proarrhythmic conditions or on concomitant medications that affect cardiac conduction; closely monitor these patients ( 5.3 , 7.2 ) \u2022 Lacosamide may cause syncope ( 5.4 ) \u2022 Lacosamide should be gradually withdrawn to minimize the potential of increased seizure frequency ( 5.5 ) \u2022 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/ Multi-Organ Hypersensitivity: Discontinue if no alternate etiology ( 5.6 ) 5.1 Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including lacosamide, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed ...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are described below and elsewhere in the labeling: \u2022 Suicidal Behavior and Ideation [see Warnings and Precautions (5.1) ] \u2022 Dizziness and Ataxia [see Warnings and Precautions (5.2) ] \u2022 Cardiac Rhythm and Conduction Abnormalities [see Warnings and Precautions (5.3) ] \u2022 Syncope [see Warnings and Precautions (5.4) ] \u2022 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Reactions [see Warnings and Precautions (5.6) ] \u2022 Adjunctive therapy: Most common adverse reactions in adults (\u226510% and greater than placebo) are diplopia, headache, dizziness, nausea, and somnolence ( 6.1 ) \u2022 Monotherapy: Most common adverse reactions are similar to those seen in adjunctive therapy studies ( 6.1 ) \u2022 Pediatric patients: Adverse reactions are similar to those seen in adult patients ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance Lacosamide is a Schedule V controlled substance. 9.2 Abuse Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. In a human abuse potential study, single doses of 200 mg (equal to the maximum single dosage) and 800 mg lacosamide (equal to twice the recommended daily maintenance dosage) produced euphoria-type subjective responses that differentiated statistically from placebo; at 800 mg, these euphoria-type responses were statistically indistinguishable from those produced by alprazolam, a Schedule IV drug. The duration of the euphoria-type responses following lacosamide was less than that following alprazolam. A high rate of euphoria was also reported as an adverse event in the human abuse potential study following single doses of 800 mg lacosamide (15% [5/34]) compared to placebo (0%) and in two pharmacokinetic studies following single and multiple doses of 300 mg to 800 mg lacosamide (ranging from 6% [2/33] to 25% [3/12]) compared to placebo (0%). However, the rate of euphoria reported as an adverse event in the lacosamide development program at therapeutic doses was less than 1%. 9.3...",
  "controlled_substance": "9.1 Controlled Substance Lacosamide is a Schedule V controlled substance.",
  "recent_major_changes": "Dosage and Administration ( 2.1 , 2.2 ) 4/2023",
  "information_for_patients": "Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide). Suicidal Thinking and Behavior Patients, their caregivers, and families should be counseled that AEDs, including lacosamide, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers [see Warnings and Precautions (5.1) ] . Dizziness and Ataxia Patients should be counseled that lacosamide use may cause dizziness, double vision, abnormal coordination and balance, and somnolence. Patients taking lacosamide should be advised not to drive, operate complex machinery, or engage in other hazardous activities until they have become accustomed to any such effects associated with lacosamide [see Warnings and Precautions (5.2) ] . Cardiac Rhythm and Conduction Abnormalities Patients should be counseled that lacosamide is associated with electrocardiographic changes that may predispose to irregular heart beat a...",
  "spl_medguide": "MEDICATION GUIDE Lacosamide Tablets CV (la KOE sa mide) film coated tablet, for oral use, CV Read this Medication Guide before you start taking lacosamide tablets and each time you get a refill. There may be new information. This Medication Guide describes important safety information about lacosamide tablets. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about lacosamide tablets? Do not stop taking lacosamide tablets without first talking to your healthcare provider. Stopping lacosamide tablets suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus). Lacosamide tablets can cause serious side effects, including: \u2022 Like other antiepileptic drugs, lacosamide tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: \u2022 thoughts about suicide or dying \u2022 attempt to commit suicide \u2022 new or worse depr...",
  "clinical_studies": "14.1 Monotherapy in Patients with Partial-Onset Seizures The efficacy of lacosamide in monotherapy was established in a historical-control, multicenter, randomized trial that included 425 patients, age 16 to 70 years, with partial-onset seizures (Study 1). To be included in Study 1, patients were required to be taking stable doses of 1 or 2 marketed antiepileptic drugs. This treatment continued into the 8 week baseline period. To remain in the study, patients were required to have at least 2 partial-onset seizures per 28 days during the 8 week baseline period. The baseline period was followed by a 3 week titration period, during which lacosamide was added to the ongoing antiepileptic regimen. This was followed by a 16-week maintenance period (i.e., a 6-week withdrawal period for background antiepileptic drugs, followed by a 10-week monotherapy period). Patients were randomized 3 to 1 to receive lacosamide 400 mg/day or lacosamide 300 mg/day. Treatment assignments were blinded. Response to treatment was based upon a comparison of the number of patients who met exit criteria during the maintenance phase, compared to historical controls. The historical control consisted of a pooled an...",
  "brand_name": "Lacosamide",
  "manufacturer": "Proficient Rx LP",
  "application_number": "ANDA205237",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240501",
  "set_id": "47ae2f1f-d135-4f4e-acc2-500c1afa7b8b",
  "has_boxed_warning": false,
  "controlled": true,
  "mentions_rems": false
 },
 "faers": {
  "total": 33314,
  "serious": 26312,
  "death": 2835,
  "hospitalization": 11559,
  "primary_suspect": 33110,
  "top_reactions": [
   [
    "Seizure",
    6878
   ],
   [
    "Drug Ineffective",
    3941
   ],
   [
    "Off Label Use",
    3922
   ],
   [
    "Dizziness",
    1417
   ],
   [
    "Somnolence",
    1337
   ],
   [
    "Epilepsy",
    1312
   ],
   [
    "Fatigue",
    1286
   ],
   [
    "Fall",
    1264
   ],
   [
    "Overdose",
    1199
   ],
   [
    "Generalised Tonic-Clonic Seizure",
    1195
   ],
   [
    "Status Epilepticus",
    1141
   ],
   [
    "Death",
    985
   ],
   [
    "Headache",
    952
   ],
   [
    "Drug Interaction",
    869
   ],
   [
    "Multiple-Drug Resistance",
    816
   ]
  ],
  "by_year": {
   "2019": 3798,
   "2020": 2960,
   "2021": 3570,
   "2022": 3207,
   "2023": 3136,
   "2024": 3493,
   "2025": 3308,
   "2026": 1547
  },
  "by_year_primary": {
   "2019": 3796,
   "2020": 2954,
   "2021": 3551,
   "2022": 3180,
   "2023": 3102,
   "2024": 3444,
   "2025": 3260,
   "2026": 1531
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260604",
   "reason": "Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.",
   "firm": "Annora Pharma Private Limited",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250313",
   "reason": "CGMP Deviations",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250313",
   "reason": "CGMP Deviations",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250313",
   "reason": "CGMP Deviations",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250313",
   "reason": "CGMP Deviations",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20221206",
   "reason": "Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content",
   "firm": "Camber Pharmaceuticals, Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20210315",
   "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
   "firm": "Cardinal Health Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 7,
 "drugsfda": {
  "applications": 50,
  "nda": 4,
  "anda": 44,
  "first_approval": "20081028",
  "rems": false,
  "rems_last": "20110810",
  "labeling_supplements": 49,
  "labeling_recent": 12,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ACELLA",
   "ACTAVIS LABS FL INC",
   "ADAPTIS",
   "AJENAT PHARMS",
   "ALEMBIC",
   "ALKEM LABS LTD",
   "AMNEAL PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "10/28/2008"
 },
 "trials": {
  "total": 121,
  "completed": 84,
  "terminated": 16,
  "with_results": 54,
  "industry": 74,
  "phase3": 41,
  "results_share": 0.6428571428571429,
  "terminated_share": 0.1322314049586777
 },
 "pubmed": {
  "rct": 57,
  "meta": 22,
  "recent_rct": 16,
  "cochrane": [
   {
    "pmid": "33998660",
    "title": "Lacosamide add-on therapy for focal epilepsy",
    "year": "2021"
   },
   {
    "pmid": "26077821",
    "title": "Lacosamide add-on therapy for partial epilepsy",
    "year": "2015"
   },
   {
    "pmid": "22336864",
    "title": "Lacosamide for neuropathic pain and fibromyalgia in adults",
    "year": "2012"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 101.94,
  "records": 5,
  "by_name": [
   [
    "Vimpat",
    101.94
   ]
  ],
  "names_checked": [
   "lacosamide",
   "Vimpat",
   "Motpoly"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 931819,
  "beneficiaries": 126122,
  "spend": 175910241.42,
  "by_brand": [
   {
    "brand": "Lacosamide",
    "claims": 887424,
    "per_claim": 125.02009789,
    "is_generic": true
   },
   {
    "brand": "Vimpat",
    "claims": 44046,
    "per_claim": 1465.9711651,
    "is_generic": false
   },
   {
    "brand": "Motpoly XR",
    "claims": 349,
    "per_claim": 1129.6278797,
    "is_generic": false
   }
  ],
  "per_claim": 188.7815567400965
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 8235,
  "fills": 931819,
  "per_million": 8837.553215806933,
  "ratio": 3.191662544150223,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 75,
   "letter": "B",
   "why": [
    "8,838 FDA reports naming it as the suspect drug per million Medicare fills, 3.2x the median drug on this site (-10)",
    "Federally controlled substance: dependence and misuse risk (-10)",
    "Death share in reports is near or below the FAERS average (0.9x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 61,
   "letter": "D",
   "why": [
    "57 randomized trials and 22 systematic reviews/meta-analyses indexed in PubMed",
    "3 independent Cochrane review(s) exist"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 81,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 6 Class II, 1 Class III across 44 generic makers (-6)",
    "12 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $102 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (44 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 76,
 "grade": "B",
 "questions": [
  "This is a controlled substance. What is the plan for how long I take it and how I stop?",
  "The most-reported problems in FDA's adverse event data are seizure, dizziness. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}