Lamictal has been approved in over 30 markets for the treatment of bipolar disorder. It is joined by valproate and carbamazepine – anticonvulsant drugs which later received licenses for bipolar disorder. Unlike other mood stabilizers (such as lithium, valproate, and carbamazepine) that are effective primarily in mania, Lamictal appears to primarily work by stabilizing the depressive symptoms of patients. These symtoms, related to the depressive pole, are responsible for the greatest amount of suffering and disability.

Strengths:

• First product indicated for the prevention of bipolar depression (EU/International).
• First product indicated for delaying the occurrence of mood episodes (mania, hypomania, depression, and mixed
  episodes) (USA).
• Once-daily dosing.
• Does not cause cognitive impairment as a side effect.
• Blood monitoring is not required.
• Does not destabilize mood.
• Does not cause weight gain.
• APA guidelines recommend the use of Lamictal for acute depression.
• ICG guidelines recommend the use of Lamictal as first-line therapy.
• A starter pack is available to improve titration to the correct dose, minimizing the risk of rash.
• There is extensive product experience and use due to existing indications for epilepsy.
• Well tolerated with minimal drug–drug interactions.
• Strong KOL relationships.
• Excellent clinical trial and regulatory experience.
• Worldwide launch capabilities.
• Extensive market analysis and research has been conducted.

Weaknesses:

• Associated with severe rash in a small percentage of patients.
• Associated with benign rash in approximately 11% of patients, which is difficult to distinguish from severe rash in the early stages, raising the barrier to prescription.
• Dosage titration is required to minimize the risk of rash.
• Increased risk of rash when used in conjunction with valproate.
• Patent expiry will occur in May 2005 in the EU and January 2009 in the USA (worst case scenario).
• Lack of definitive data on efficacy in acute mania (including failed studies).
• Lack of data on efficacy in unipolar depression.
• Lack of data on combination therapy.
• Principal efficacy is in the depressive pole; therefore, Lamictal is not a monotherapy solution.
• Lack of data on the maintenance of bipolar II disorder.
• High cost compared with current mood stabilizers.
• GSK is reducing SOV with psychiatrists.

Opportunities:

• Large and growing market: 1% worldwide prevalence, 6.6 million patients in G7 countries, 10% CAGR.
• Opportunity for market expansion.
• Low rates of diagnosis (currently, only 50–60% of bipolar patients are treated).
• Use in acute bipolar depression.
• Use in bipolar II disorder.
• Failure to correctly diagnose bipolar depression (often misdiagnosed as unipolar depression).
• High unmet medical need.
• High cost to society supports the price of effective drugs.
• Market interest in combination regimens.
• Competitor drugs have poor tolerability profiles.
• Increased awareness of the benefits of Lamictal use to quality of life.
• Efficacious as an add-on therapy in schizophrenia.

Threats:

• Perception that current mania stabilizers also work for depression.
• Lack of data on efficacy in acute mania/hypomania.
• Competition is perceived as less expensive.
• Depression is often overlooked – mania remains the icon of bipolar disorder.
• OFC approved for acute bipolar depression but will also claim an antimanic component.
• High SOV and 'noise' from Lilly (olanzapine).