Abstract
Introduction
A poorly understood, complex disease that involves a number of
neurotransmitters, bipolar disorder presents several challenges for
pharmaceutical companies seeking to develop new treatments. While lithium and
several antiepileptic and antipsychotic agents are currently used to treat
either manic or mixed episodes of BPD, only Eli Lilly’s Symbyax and
AstraZeneca’s Seroquel have received FDA approval for treatment of
bipolar depression. The numerous unmet therapeutic needs resulting from the
incomplete understanding of BPD create significant opportunities within the
competitive BPD market.
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Bipolar disorder represents a market with significant opportunity, but few
drug companies are actively developing new agents. What obstacles are
currently deterring companies from entering the BPD market? What challenges
need to be addressed, and what therapeutic needs remain unmet?
The treatment of depression associated with BPD has not been as extensively
studied as the treatment of either unipolar depression or bipolar mania.
What strategies does treatment of bipolar depression rely upon? Which
classes of antidepressants appear to be the most effective for treating
bipolar depression?
Several agents have received specifi c approval for treating BPD; other agents
are commonly used off-label. Which agents are most frequently used as
off-label treatments for BPD? What competitive advantages, if any, does FDA
approval provide? Which companies are specifi cally pursuing FDA approval for
their BPD agents?
Scope
- BPD background: Symptoms, pathophysiology, and etiology.
- Treatment options: Current therapies for the four common types of
episodes associated with bipolar I disorder and bipolar II disorder.
- Market dynamics: Sales growth statistics for BPD-approved agents
versus non-BPD-approved agents; sales and prescriptions of antipsychotics and
antiepileptics in the United States.
- Emerging therapies: Antipsychotics and sodium- and calcium-channel
blockers currently in development, along with novel approaches.
- Market outlook: Limitations of current BPD agents; challenges still
remaining; and the likelihood that any one agent will dominate the BPD market.
Companies Mentioned in This Spectrum Report
- Abbott Laboratories
- AstraZeneca
- Bristol-Myers Squibb
- Dainippon
- D-Pharm
- Eli Lilly
- Forest Laboratories
- Gedeon Richter
- GlaxoSmithKline
- Hoechst Marion Roussel
- Janssen
- Janssen-Cilag International
- Johnson & Johnson
- Kyowa Hakko
- H. Lundbeck
- Marinus Pharmaceuticals
- McNeil
- Memory Pharmaceuticals
- Novartis
- Organon
- Ortho-McNeil
- Otsuka Pharmaceutical
- Pfi zer
- Repligen
- Sanofi -Aventis
- Shire Pharmaceutical
- Solvay Pharmaceuticals
- Taisho
- Titan Pharmaceuticals
- Vanda Pharmaceuticals
- Wyeth