 DecisionBase PDFs --
2008
 Overview:
The insomnia market has the potential to be one of the
remaining blockbuster markets in the drug industry, owing to the combination of
a prevalent population of more than 140 million individuals, steadily growing
diagnosis and drug-treatment rates, and a small number of branded drugs.
Moreover, the unmet needs for this disorder are numerous (e.g., more-selective
treatments, agents with no abuse potential, agents lacking residual next-day
effects, safe and effective therapies for chronic insomnia). Efficacious
emerging therapies that can address key remaining unmet needs stand to enjoy
considerable commercial success. However, because insomnia is considered a low-severity
disorder, emerging therapies must also have a highly favorable safety and
tolerability profile to gain widespread use.
Questions Answered in This Report:
 A drug’s performance on at least five efficacy end points,
including latency to sleep onset and sleep efficiency, is important for drug
approval and physician use. What are the key primary and secondary clinical
trial end points with which new therapies are evaluated? How do primary care
physicians weight efficacy measures and other drug attributes in their
prescribing decisions for insomnia?
Zolpidem (Sanofi-Aventis’s Ambien, generics) is the 2006
major-market sales leader for insomnia. How will emerging agents fare against
zolpidem? Will emerging therapies offer improvements in the efficacy end points
and drug attributes that are most influential in physician prescribing
decisions? Which emerging therapies, if any, are best positioned to challenge
the market-leading status of zolpidem?
Based on its clinical profile, controlled-release zolpidem
is the 2006 clinical gold standard in our drug comparator model. However, by
2011, low-dose doxepin will emerge as the gold-standard therapy in our model because of its improved clinical profile over the current
therapies evaluated in this study. On what clinical attributes is low-dose
doxepin most differentiated from its competitors? Which current therapies are
at greatest risk of being replaced by low-dose doxepin?
Scope:
Key drug development opportunity tested in our target
product profiles for insomnia: A hypnotic that is free of next-day residual
effects for the treatment of insomnia.
Physicians surveyed for this study: 60 U.S. primary care physicians.
Comprehensive List of Therapies Included in Our Research and
Modeling
Current therapies:
- Zolpidem (Sanofi-Aventis’s Ambien, generics)
- Controlled-release zolpidem (Sanofi-Aventis’s Ambien CR)
- Eszopiclone (Sepracor’s Lunesta)
- Ramelteon (Takeda’s Rozerem)
- Zaleplon (King Pharmaceuticals/Wyeth’s Sonata)
Emerging therapies:
- Low-dose doxepin (Somaxon’s Silenor)
- Eplivanserin (Sanofi-Aventis)
- VEC-162 (Vanda)
- HY-10275 (Eli Lilly)
- Adipiplon (Neurogen)
About DecisionBase
Insomnia: To Gain Share, Emerging Therapies Must Improve
Side Effects Without Compromising Efficacy is a DecisionBase 2008 study from
Decision Resources. DecisionBase 2008 combines market forecasts with clinical
and commercial end points to assess market share projections in 35 indications.
These outputs are driven by quantitative and qualitative primary research.
DecisionBase 2008 provides detailed market share, patient share, and
price-per-day projections for emerging drugs in development. The market share
projections are based on prescriber surveys that compare physicians’
expectations of a potential target product profile with an emerging product
profile of the leading drugs in development.
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