Lamictal ODT and XR

Drug - Lamictal ODT, Lamictal XR (lamotrigine) [GlaxoSmithKline]

December 2009

Therapeutic area - Anticonvulsant

FDA approved indication

Indications

• Lamictal ODT has the same indications as Lamictal tablets and chewable dispersible tablets.
• Lamictal XR indication is limited to partial onset seizures with or without secondary generalization in patients ≥13 years of age.

Criteria

Lamictal ODT

A patient can not otherwise swallow or be administered a lamotrigine tablet.

Lamictal XR

• Lamictal XR is being used as indicated for adjunctive therapy for partial onset seizures with or without secondary generalization in patients ≥13 years of age AND
• Patient has been stabilized on lamotrigine with benefit AND
• Patient would benefit clinically from once daily dosing

Rationale

Table 1. Pricing per tablet

Strength	Tablet Generic (mac)	ODT AWP-15%	XR AWP-15%
25 mg	$0.10	$4.33	$4.33
50 mg	NA	$4.64	$8.66
100 mg	$0.14	$4.95	$9.28
150 mg	$0.20	NA	NA
200 mg	$0.20	$5.91	$9.90

NA - strength not available in that formulation

Pharmacokinetic comparison ODT to tablet

In terms of rate and extent of absorption, lamotrigine orally disintegrating tablets whether disintegrated in the mouth or swallowed whole with water were equivalent to the lamotrigine compressed tablets swallowed with water.

Questions?

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