LAMICTAL ODT (lamotrigine)
Lamictal ODT (lamotrigine) is an anti-epileptic agent and mood stabilizer used to manage specific seizure types and bipolar I disorder. It is indicated as adjunctive therapy for partial-onset, primary generalized tonic-clonic, and Lennox-Gastaut syndrome seizures in patients aged two years and older, and as monotherapy for partial-onset seizures in patients aged 16 and older converting from certain other anti-epileptic drugs. Additionally, the medication is used for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes. The drug is not recommended for the treatment of acute manic or mixed episodes.
How LAMICTAL ODT Works
While the precise mechanism of action is unknown, lamotrigine is thought to inhibit voltage-sensitive sodium channels. By blocking these channels, the drug stabilizes neuronal membranes and modulates the presynaptic release of excitatory neurotransmitters like glutamate and aspartate. This activity helps prevent the spread of seizures in animal models, though the relevance to human epilepsy is not fully established. The specific mechanism by which the drug functions as a maintenance treatment for bipolar disorder has not been determined.
Details
- Status
- Prescription
- First Approved
- 2009-05-08
- Routes
- ORAL
- Dosage Forms
- TABLET, ORALLY DISINTEGRATING
LAMICTAL ODT Approval History
What LAMICTAL ODT Treats
5 indicationsLAMICTAL ODT is approved for 5 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Epilepsy
- Partial-Onset Seizures
- Generalized Tonic-Clonic Seizures
- Lennox-Gastaut Syndrome
- Bipolar Disorder
LAMICTAL ODT Boxed Warning
SERIOUS SKIN RASHES Lamotrigine can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.3% to 0.8% in pediatric patients (aged 2 to 17 years) and 0.08% to 0.3% in adults receiving lamotrigine. One rash-related death was reported in a prospectively followed cohort of 1,983 pediatric patients (aged 2 to 16 years) with epilepsy taking lamotrigine as adjunctive therapy. In wor...
WARNING: SERIOUS SKIN RASHES Lamotrigine can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.3% to 0.8% in pediatric patients (aged 2 to 17 years) and 0.08% to 0.3% in adults receiving lamotrigine. One rash-related death was reported in a prospectively followed cohort of 1,983 pediatric patients (aged 2 to 16 years) with epilepsy taking lamotrigine as adjunctive therapy. In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate. Other than age, there are as yet no factors identified that are known to predict the risk of occurrence or the severity of rash caused by lamotrigine. There are suggestions, yet to be proven, that the risk of rash may also be increased by (1) coadministration of lamotrigine with valproate (includes valproic acid and divalproex sodium), (2) exceeding the recommended initial dose of lamotrigine, or (3) exceeding the recommended dose escalation for lamotrigine. However, cases have occurred in the absence of these factors. Nearly all cases of life-threatening rashes caused by lamotrigine have occurred within 2 to 8 weeks of treatment initiation. However, isolated cases have occurred after prolonged treatment (e.g., 6 months). Accordingly, duration of therapy cannot be relied upon as means to predict the potential risk heralded by the first appearance of a rash. Although benign rashes are also caused by lamotrigine, it is not possible to predict reliably which rashes will prove to be serious or life threatening. Accordingly, lamotrigine should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug related. Discontinuation of treatment may not prevent a rash from becoming life threatening or permanently disabling or di
LAMICTAL ODT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
41 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06929273 | CN012-0038 U1111-1316-9287, 2024-520259-26 | Ph 3 | recruiting | A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3) |
| NCT06184581 LiLa-Bipolar | 2023-509607-32-00 10.46540/2096-00007B | Ph 4 | recruiting | Lithium Versus Lamotrigine in Bipolar Disorder, Type II |
| NCT06729970 | CN012-0035 | Ph 1 | completed | A Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Pharmacokinetics of KarXT and Effects of KarXT on the Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants |
| NCT04770493 results posted | 2004002676 R21AA028394 | Ph 2 | completed | Enhancing the Effects of Alcohol Treatment With Lamotrigine |
| NCT05881928 | lamotrigine , sodium valproate | Ph 4 | not yet recruiting | Effect of Adding Lamotrigine to Sodium Valproate in Childhood Epilepsy: Clinicolabratory Study |
| NCT04602221 results posted | 1289-0057 | Ph 1 | completed | A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine |
| NCT03504501 SynCoRAS | SYN-1748-MAL-0030-I 2016-005022-10 | Ph 2 | terminated | Synaptic Plasticity and Cognitive Function in RASopathies |
| NCT02158585 results posted | Zhang-001 | Ph 2 | completed | Study of Lamotrigine to Treat Ménière's Disease |
| NCT00571246 | 0705002634 | Ph 3 | withdrawn | The Use of Anticonvulsants for Treatment of Patients With Alcohol Dependence and Post Traumatic Stress Disorder |
| NCT00618241 GRANOLA | UMCN-AKF 07.06 | Ph 1 | completed | Pharmacokinetic Study on Raltegravir and Lamotrigine |
| NCT01588457 SMART results posted | HSC20110361H 1P30MH086045-01A2 | Ph 4 | completed | Sequential Multiple Assignment Treatment for Bipolar Disorder |
| NCT02708849 results posted | 1501015203 | Ph 1 | terminated | The Sustained Effects of Ketamine |
| NCT03695094 results posted | UP0070 2018-001941-16 | Ph 1 | completed | A Study in Participants With Epilepsy, to Evaluate the Pharmacokinetics, Safety and Tolerability of Oxcarbazepine on Padsevonil |
| NCT02256124 NF1-EXCEL | MEC-2013-460 2013-003405-26, NL 44912.078.13 | Ph 2, Ph 3 | terminated | Effect of Lamotrigine on Cognition in NF1 |
| NCT01674010 results posted | ELND005-BPD201 2012-001935-30 | Ph 2 | terminated | Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder |
| NCT04015687 | AG881-C-006 | Ph 1 | completed | A Study to Evaluate the Effect of AG-881 on the Pharmacokinetics of a Single Dose of Lamotrigine in Healthy Adults |
| NCT02389712 FLAME results posted | 13-003545-1 UL1TR000135 | Ph 4 | terminated | 16-week Comparative Effectiveness Trial of Lamotrigine vs. Fluoxetine for Bipolar Depression |
| NCT03898011 | LMTR-270418 v.1.1 01/29/2019 | Ph 1 | completed | A Bioequivalence Study of Two Formulations Lamotrigine 100 mg Tablets and Lamictal 100 mg Tablets in Healthy Adult Volunteers Under Fasting Conditions |
| NCT01015586 results posted | HR#19550 K23AA017666 | Ph 4 | completed | Treatment of Alcohol Dependence and Comorbid Bipolar Disorder |
| NCT01142310 results posted | 122009-028 R01MH082845 | Ph 4 | completed | Reversing Corticosteroid Induced Memory Impairment |
| NCT02081287 | DBDAT-2013-MJM | Ph 1 | completed | Inositol Hexaphosphate: A Novel Treatment Strategy for Bipolar Disorder? |
| NCT02374567 GAP | GAP-2014 | Ph 3 | terminated | Pharmacovigilance in Gerontopsychiatric Patients |
| NCT02556060 | TCHIRB-102309 | Ph 2, Ph 3 | completed | Lamotrigine for Ketamine Dependence Trial |
| NCT01357902 | 115261 | Ph 1 | completed | Lamotrigine Bioequivalence Study to Compare Dispersible Tables With Compressed Tablets in China |
| NCT01891890 COPE results posted | IRB00066541 PCORI 527 | Ph 3 | terminated | Cognitive AED Outcomes in Pediatric Localization Related Epilepsy (COPE) |
| NCT00627575 | LEP108937 | Ph 1 | completed | AED/Statin Interaction Study |
| NCT00907985 | 112676 | Ph 1 | terminated | A Study to Evaluate the Effect of Single Doses of Drug A (Lamotrigine) and Drug B (Vofopitant) Alone and in Combination on Resting Motor Threshold in Healthy Subjects |
| NCT01733394 | EQUIGEN Single Dose Protocol 005-1005 | Ph 4 | completed | Equivalence Among Antiepileptic Drug Generic and Brand Products in People With Epilepsy: Single-Dose 6-Period Replicate Design (EQUIGEN Single-Dose Study) |
| NCT02513654 | 114536 | Ph 1 | completed | Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects |
| NCT01602510 results posted | 113783 | Ph 3 | completed | Lamotrigine Phase III Study in Bipolar I Disorder |
| NCT00579982 results posted | LBI108884 | Ph 3 | completed | An Open-Label Trial Measuring Satisfaction And Convenience Of Two Formulations Of Lamotrigine In Subjects With A Mood Disorder |
| NCT01939561 | 2013-MY 2013-003309-24 | Ph 3 | completed | Lamotrigine as Treatment of Myotonia |
| NCT01042496 1HMRS-BP results posted | 09-004163 R01MH079261-01A2 | Ph 3 | completed | Bipolar Depression Before and After Lamotrigine Treatment |
| NCT02303106 | AKF-386 | Ph 4 | completed | Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study |
| NCT01888731 | 717/09 | Ph 1 | completed | Bioequivalence Study of Lamotrigine Extended-Release Tablets 50 mg Under Fasting Condition |
| NCT01888757 | 718/09 | Ph 1 | completed | Lamotrigine Extended-Release Tablets 50 mg Under Fed Condition |
| NCT01888263 | 672/09 | Ph 1 | completed | Bioequivalence Study of Lamotrigine Extended-Release Tablets 200mg Under Fed Condition |
| NCT01888250 | 671/09 | Ph 1 | completed | Bioequivalence Study of Lamotrigine Extended-Release Tablets 200mg Under Fasting Condition |
| NCT01864551 OCTLPODEPWBD | TSGH 097-05-061 | Ph 4 | completed | Olanzapine Compared to Lamotrigine in the Prevention of Depressive Episode in the Patients With Bipolar Disorder |
| NCT01618825 | Ipca/BA/1264034 | Ph 1 | completed | Bioequivalence Study of Lamotrigine Tablets 25 mg (2 x 25 mg Tablets) Under Fed Condition |
| NCT01618799 | Ipca/BA/1264033 | Ph 1 | completed | Bioequivalence Study of Lamotrigine Tablets 25 mg (2 x 25 mg Tablets) Under Fasting Condition |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LAMICTAL ODT FDA Label Details
Indications & Usage
FDA Label (PDF)LAMICTAL ODT is indicated for the treatment of Epilepsy; Partial-Onset Seizures; Generalized Tonic-Clonic Seizures; Lennox-Gastaut Syndrome; Bipolar Disorder.
WARNING: SERIOUS SKIN RASHES Lamotrigine can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.3% to 0.8% in pediatric patients (aged 2 to 17 years) and 0.08% to 0.3% in adu...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.