Lamictal and Lamictal XR
Author: Ines Guerra
Publisher: Datamonitor Healthcare
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Drug Overview
Lamictal (GlaxoSmithKline) contains lamotrigine, a phenyltriazine antiepileptic drug that acts at voltage-sensitive sodium channels to stabilize neuronal membranes and inhibits the release of excitatory amino acid neurotransmitters. Lamictal initially launched as an adjunctive treatment for epilepsy in the US and EU in 1995 and 1997, respectively. In June 2003, the US Food and Drug Administration approved Lamictal for the long-term maintenance treatment of adults with bipolar I disorder.
Lamictal boasts a strong clinical profile, possessing superior tolerability compared to atypical antipsychotics. As the only anticonvulsant indicated for the maintenance phase of bipolar disorder, Lamictal carved a niche for itself for patients with depressive episodes. While Lamictal is yet to be approved for bipolar depression, its significant efficacy makes it amenable to off-label use in patients experiencing acute bipolar depression. This provides a prominent advantage to GlaxoSmithKline as it enjoys substantial market share in a less competitive space in the bipolar treatment algorithm without participating in the regulatory approval process. While Lamictal is clinically attractive, its commercial prospects in bipolar disorder are hampered by the widespread availability of lamotrigine generics.
TABLE OF CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 Lamictal : Bipolar disorder
15 Lamictal and Lamictal XR : Epilepsy
LIST OF FIGURES
10 Figure 1: Lamictal for bipolar disorder – SWOT analysis
11 Figure 2: Datamonitor Healthcare’s drug assessment summary for Lamictal in bipolar disorder
12 Figure 3: Datamonitor Healthcare’s drug assessment summary for Lamictal in bipolar disorder
32 Figure 4: Lamictal/Lamictal XR for epilepsy – SWOT analysis
33 Figure 5: Datamonitor Healthcare’s drug assessment summary for Lamictal in epilepsy
34 Figure 6: Datamonitor Healthcare’s drug assessment summary for Lamictal in epilepsy
LIST OF TABLES
5 Table 1: Lamictal bipolar disorder indication approvals
6 Table 2: Lamictal drug profile
7 Table 3: Overview of clinical trial data for Lamictal in maintenance treatment of adults with bipolar I disorder
8 Table 4: Key side effects reported in clinical trials of Lamictal as a maintenance therapy in adults with bipolar I disorder
9 Table 5: Selected clinical trials of Lamictal in bipolar depression
16 Table 6: Lamictal/Lamictal XR epilepsy indication approvals
19 Table 7: Lamictal and Lamictal XR drug profile
21 Table 8: Lamictal pivotal trial data in epilepsy
26 Table 9: Safety profile for Lamictal in epilepsy
28 Table 10: Lamictal XR pivotal trial data in epilepsy
31 Table 11: Safety profile for Lamictal XR in epilepsy
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